Armodafinil
Drug150 mg/day armodafinil
Other names: R-modafinil, CEP-10953
NCT Number: NCT00772005
The primary objective of the study is to evaluate whether armodafinil treatment is more effective than placebo as adjunctive therapy to antipsychotic medication in alleviating the negative symptoms of schizophrenia
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Notify Me18 year–65 year
All sexes
Interventional
Phase 2
K and S Professional Research Services, LLC, Little Rock, Arkansas, United States
This study was designed and was powered to evaluate the efficacy and safety of armodafinil treatment at dosages of 150, 200, and 250 mg/day compared with placebo over 24 weeks as an adjunctive therapy to antipsychotic medication (olanzapine, oral risperidone, or paliperidone) in adults with schizophrenia who were clinically stable at study entry. Specifically, the effects of armodafinil treatment on the negative symptoms of schizophrenia were the primary assessment in this study.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
150 mg/day armodafinil
Other names: R-modafinil, CEP-10953
placebo
Time frame: Baseline and Endpoint (Week 24 or last observation after baseline)
PANSS rates severity of psychopathology in schizophrenics. 7 items measure NEGATIVE symptoms: blunted affect, social withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Negative Scale score ranges from 7-49 (higher more severe). Data represents change in Negative Rating Scale from baseline to endpoint with positive scores indicating more severe pathology.
Time frame: Baseline and Endpoint (Week 24 or last observation after baseline)
PANSS is a clinician rating severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Total scores range from 30 to 210. Data represents change in total score from baseline to endpoint, higher (positive) scores indicate more severe pathology.
Time frame: Baseline and Week 1
PANSS rates severity of psychopathology in schizophrenics. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg.anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Total scores range from 30 to 210. The data here represents the change in total score from baseline to week 1 and higher (positive) scores indicate more severe pathology.
Time frame: Baseline and Week 2
PANSS is a clinician rating severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Total scores range from 30 to 210. Data represents the change in total score from baseline to week 2, higher (positive) scores indicate more severe pathology.
Time frame: Baseline and Week 4
PANSS is a clinician rating severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Total scores range from 30 to 210. Data represents the change in total score from baseline to week 4, higher (positive) scores indicate more severe pathology.
Time frame: Baseline and Week 8
PANSS is a clinician rating severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Total scores range from 30 to 210. Data represents the change in total score from baseline to week 8, higher (positive) scores indicate more severe pathology.
Time frame: Baseline and Week 12
PANSS is a clinician rating severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Total scores range from 30 to 210. Data represents the change in total score from baseline to week 12, higher (positive) scores indicate more severe pathology.
Time frame: Baseline and Week 16
PANSS is a clinician rating severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Total scores range from 30 to 210. Data represent the change in total score from baseline to week 16, higher (positive) scores indicate more severe pathology.
Time frame: Baseline and Week 20
PANSS is a clinician rating severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Total scores range from 30 to 210. Data represents the change in total score from baseline to week 20, higher (positive) scores indicate more severe pathology.
Time frame: Baseline and Week 24
PANSS is a clinician rating severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Total scores range from 30 to 210. Data represent the change in total score from baseline to week 24, higher (positive) scores indicate more severe pathology.
Time frame: Baseline and Week 1
PANSS rates the severity of psychopathology in schizophrenics. 7 items measure negative symptoms: blunted affect, social withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Data represents change in Negative Rating Scale from baseline to week 1. Negative Scale score ranges from 7 to 49, higher (positive) score indicates more severe pathology.
Time frame: Baseline and Week 2
PANSS rates the severity of psychopathology in schizophrenics. 7 items measure negative symptoms: blunted affect, social withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Data represents change in Negative Rating Scale from baseline to week 2. Negative Scale score ranges from 7 to 49, higher (positive) score indicates more severe pathology.
Time frame: Baseline and Week 4
PANSS rates the severity of psychopathology in schizophrenics. 7 items measure negative symptoms: blunted affect, social withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Data represents change in Negative Rating Scale from baseline to week 4. Negative Scale score ranges from 7 to 49, higher (positive) score indicates more severe pathology.
Time frame: Baseline and Week 8
PANSS rates the severity of psychopathology in schizophrenics. 7 items measure negative symptoms: blunted affect, social withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Data represents change in Negative Rating Scale from baseline to week 8. Negative Scale score ranges from 7 to 49, higher (positive) score indicates more severe pathology.
Time frame: Baseline and Week 12
PANSS rates the severity of psychopathology in schizophrenics. 7 items measure negative symptoms: blunted affect, social withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Data represents change in Negative Rating Scale from baseline to week 12. Negative Scale score ranges from 7 to 49, higher (positive) score indicates more severe pathology.
Time frame: Baseline and Week 16
PANSS rates the severity of psychopathology in schizophrenics. 7 items measure negative symptoms: blunted affect, social withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Data represents change in Negative Rating Scale from baseline to week 16. Negative Scale score ranges from 7 to 49, higher (positive) score indicates more severe pathology.
Time frame: Baseline and Week 20
PANSS rates the severity of psychopathology in schizophrenics. 7 items measure negative symptoms: blunted affect, social withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Data represents change in Negative Rating Scale from baseline to week 20. Negative Scale score ranges from 7 to 49, higher (positive) score indicates more severe pathology.
Time frame: Baseline and Week 24
PANSS rates the severity of psychopathology in schizophrenics. 7 items measure negative symptoms: blunted affect, social withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Data represents change in Negative Rating Scale from baseline to week 24. Negative Scale score ranges from 7 to 49, higher (positive) score indicates more severe pathology.
Time frame: Baseline and Endpoint (Week 24 or last observation)
PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The data here represents the change in the Positive scale score from baseline to endpoint. The scale may range from 7 to 49, higher (positive) score indicating more severe pathology.
Time frame: Baseline and Week 1
PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The data here represents the change in the Positive scale score from baseline to Week 1. The scale may range from 7 to 49, higher (positive) score indicating more severe pathology.
Time frame: Baseline and Week 2
PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The data here represents the change in the Positive scale score from baseline to Week 2. The scale may range from 7 to 49, higher (positive) score indicating more severe pathology.
Time frame: Baseline and Week 4
PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The data here represents the change in the Positive scale score from baseline to Week 4. The scale may range from 7 to 49, higher (positive) score indicating more severe pathology.
Time frame: Baseline and Week 8
PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The data here represents the change in the Positive scale score from baseline to Week 8. The scale may range from 7 to 49, higher (positive) score indicating more severe pathology.
Time frame: Baseline and Week 12
PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The data here represents the change in the Positive scale score from baseline to Week 12. The scale may range from 7 to 49, higher (positive) score indicating more severe pathology.
Time frame: Baseline and Week 16
PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The data here represents the change in the Positive scale score from baseline to Week 16. The scale may range from 7 to 49, higher (positive) score indicating more severe pathology.
Time frame: Baseline and Week 20
PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The data here represents the change in the Positive scale score from baseline to Week 20. The scale may range from 7 to 49, higher (positive) score indicating more severe pathology.
Time frame: Baseline and Week 24
PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The data here represents the change in the Positive scale score from baseline to Week 24. The scale may range from 7 to 49, higher (positive) score indicating more severe pathology.
Time frame: Baseline and Endpoint (Week 24 or last observation after baseline)
PANSS rates psychopathology severity in schizophrenics. 16 items form a General Psychopathology scale:somatic concern, anxiety, guilt feeling, tension, mannerisms/posturing, depression, motor retardation, uncooperative, unusual thoughts, disorientation, poor attention, poor judgment/insight, disturbance of volition, poor impulse control, preoccupation, social avoidance. Scored on severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 16 to 112, higher (positive) score more severe pathology. Data shows change from baseline to endpoint.
Time frame: Baseline and Week 1
PANSS rates psychopathology severity in schizophrenics. 16 items form a General Psychopathology scale:somatic concern, anxiety, guilt feeling, tension, mannerisms/posturing, depression, motor retardation, uncooperative, unusual thoughts, disorientation, poor attention, poor judgment/insight, disturbance of volition, poor impulse control, preoccupation, social avoidance. Scored on severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 16 to 112, higher (positive) score more severe pathology. Data show change from baseline to week 1.
Time frame: Baseline and Week 2
PANSS rates psychopathology severity in schizophrenics. 16 items form a General Psychopathology scale:somatic concern, anxiety, guilt feeling, tension, mannerisms/posturing, depression, motor retardation, uncooperative, unusual thoughts, disorientation, poor attention, poor judgment/insight, disturbance of volition, poor impulse control, preoccupation, social avoidance. Scored on severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 16 to 112, higher (positive) score more severe pathology. Data show change from baseline to week 2.
Time frame: Baseline and Week 4
PANSS rates psychopathology severity in schizophrenics. 16 items form a General Psychopathology scale:somatic concern, anxiety, guilt feeling, tension, mannerisms/posturing, depression, motor retardation, uncooperative, unusual thoughts, disorientation, poor attention, poor judgment/insight, disturbance of volition, poor impulse control, preoccupation, social avoidance. Scored on severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 16 to 112, higher (positive) score more severe pathology. Data show change from baseline to week 4.
Time frame: Baseline and Week 8
PANSS rates psychopathology severity in schizophrenics. 16 items form a General Psychopathology scale:somatic concern, anxiety, guilt feeling, tension, mannerisms/posturing, depression, motor retardation, uncooperative, unusual thoughts, disorientation, poor attention, poor judgment/insight, disturbance of volition, poor impulse control, preoccupation, social avoidance. Scored on severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 16 to 112, higher (positive) score more severe pathology. Data show change from baseline to week 8.
Time frame: Baseline and Week 12
PANSS rates psychopathology severity in schizophrenics. 16 items form a General Psychopathology scale:somatic concern, anxiety, guilt feeling, tension, mannerisms/posturing, depression, motor retardation, uncooperative, unusual thoughts, disorientation, poor attention, poor judgment/insight, disturbance of volition, poor impulse control, preoccupation, social avoidance. Scored on severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 16 to 112, higher (positive) score more severe pathology. Data show change from baseline to week 12.
Time frame: Baseline and Week 16
PANSS rates psychopathology severity in schizophrenics. 16 items form a General Psychopathology scale:somatic concern, anxiety, guilt feeling, tension, mannerisms/posturing, depression, motor retardation, uncooperative, unusual thoughts, disorientation, poor attention, poor judgment/insight, disturbance of volition, poor impulse control, preoccupation, social avoidance. Scored on severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 16 to 112, higher (positive) score more severe pathology. Data show change from baseline to week 16.
Time frame: Baseline and Week 20
PANSS rates psychopathology severity in schizophrenics. 16 items form a General Psychopathology scale:somatic concern, anxiety, guilt feeling, tension, mannerisms/posturing, depression, motor retardation, uncooperative, unusual thoughts, disorientation, poor attention, poor judgment/insight, disturbance of volition, poor impulse control, preoccupation, social avoidance. Scored on severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 16 to 112, higher (positive) score more severe pathology. Data show change from baseline to week 20.
Time frame: Baseline and Week 24
PANSS rates psychopathology severity in schizophrenics. 16 items form a General Psychopathology scale:somatic concern, anxiety, guilt feeling, tension, mannerisms/posturing, depression, motor retardation, uncooperative, unusual thoughts, disorientation, poor attention, poor judgment/insight, disturbance of volition, poor impulse control, preoccupation, social avoidance. Scored on severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 16 to 112, higher (positive) score more severe pathology. Data show change from baseline to week 24.
Time frame: Baseline and Endpoint (Week 24 or last observation)
PANSS rates the severity of psychopathology in patients with schizophrenia. The negative symptoms factor score includes 5 negative symptoms (blunted affect, emotional withdrawal, poor rapport, positive/apathetic social withdrawal, lack of spontaneity) and 2 general psychopathology symptoms (motor retardation, active social avoidance). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 7 to 49. Higher (positive) score indicates worsening. Data represents change from baseline to endpoint.
Time frame: Baseline and Week 1
PANSS rates the severity of psychopathology in patients with schizophrenia. The negative symptoms factor score includes 5 negative symptoms (blunted affect, emotional withdrawal, poor rapport, positive/apathetic social withdrawal, lack of spontaneity) and 2 general psychopathology symptoms (motor retardation, active social avoidance). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 7 to 49. Higher (positive) score indicates worsening. Data represents change from baseline to week 1.
Time frame: Baseline and Week 2
PANSS rates the severity of psychopathology in patients with schizophrenia. The negative symptoms factor score includes 5 negative symptoms (blunted affect, emotional withdrawal, poor rapport, positive/apathetic social withdrawal, lack of spontaneity) and 2 general psychopathology symptoms (motor retardation, active social avoidance). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 7 to 49. Higher (positive) score indicates worsening. Data represents change from baseline to week 2.
Time frame: Baseline and Week 4
PANSS rates the severity of psychopathology in patients with schizophrenia. The negative symptoms factor score includes 5 negative symptoms (blunted affect, emotional withdrawal, poor rapport, positive/apathetic social withdrawal, lack of spontaneity) and 2 general psychopathology symptoms (motor retardation, active social avoidance). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 7 to 49. Higher (positive) score indicates worsening. Data represents change from baseline to week 4.
Time frame: Baseline and Week 8
PANSS rates the severity of psychopathology in patients with schizophrenia. The negative symptoms factor score includes 5 negative symptoms (blunted affect, emotional withdrawal, poor rapport, positive/apathetic social withdrawal, lack of spontaneity) and 2 general psychopathology symptoms (motor retardation, active social avoidance). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 7 to 49. Higher (positive) score indicates worsening. Data represents change from baseline to week 8.
Time frame: Baseline and Week 12
PANSS rates the severity of psychopathology in patients with schizophrenia. The negative symptoms factor score includes 5 negative symptoms (blunted affect, emotional withdrawal, poor rapport, positive/apathetic social withdrawal, lack of spontaneity) and 2 general psychopathology symptoms (motor retardation, active social avoidance). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 7 to 49. Higher (positive) score indicates worsening. Data represents change from baseline to week 12.
Time frame: Baseline and Week 16
PANSS rates the severity of psychopathology in patients with schizophrenia. The negative symptoms factor score includes 5 negative symptoms (blunted affect, emotional withdrawal, poor rapport, positive/apathetic social withdrawal, lack of spontaneity) and 2 general psychopathology symptoms (motor retardation, active social avoidance). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 7 to 49. Higher (positive) score indicates worsening. Data represents change from baseline to week 16.
Time frame: Baseline and Week 20
PANSS rates the severity of psychopathology in patients with schizophrenia. The negative symptoms factor score includes 5 negative symptoms (blunted affect, emotional withdrawal, poor rapport, positive/apathetic social withdrawal, lack of spontaneity) and 2 general psychopathology symptoms (motor retardation, active social avoidance). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 7 to 49. Higher (positive) score indicates worsening. Data represents change from baseline to week 20.
Time frame: Baseline and Week 24
PANSS rates the severity of psychopathology in patients with schizophrenia. The negative symptoms factor score includes 5 negative symptoms (blunted affect, emotional withdrawal, poor rapport, positive/apathetic social withdrawal, lack of spontaneity) and 2 general psychopathology symptoms (motor retardation, active social avoidance). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 7 to 49. Higher (positive) score indicates worsening. Data represents change from baseline to week 24.
Time frame: Baseline and Endpoint (Week 24 or last observation)
PANSS rates severity of psychopathology in patients with schizophrenia. The positive symptoms dimension is the sum of 4 positive symptoms (delusions, hallucinatory behavior, grandiosity, suspiciousness/persecution), 1 negative symptom (stereotyped thinking), and 3 general psychopathology symptoms (somatic concern, unusual thought content, lack of judgment/insight). Each item scored on 7-point scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 8 to 56. Higher (positive) scores indicate worsening. Data show change from baseline to endpoint.
Time frame: Baseline and Week 1
PANSS rates severity of psychopathology in patients with schizophrenia. Positive symptoms dimension is the sum of 4 positive symptoms (delusions, hallucinatory behavior, grandiosity, suspiciousness/persecution), 1 negative symptom (stereotyped thinking), and 3 general psychopathology symptoms (somatic concern, unusual thought content, lack of judgment/insight). Each item is scored on a 7-point scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 8 to 56. Higher (positive) scores indicate worsening. Data show change from baseline to week 1.
Time frame: Baseline and Week 2
PANSS rates severity of psychopathology in patients with schizophrenia. The positive symptoms dimension is sum of 4 positive symptoms (delusions, hallucinatory behavior, grandiosity, suspiciousness/persecution), 1 negative symptom (stereotyped thinking), and 3 general psychopathology symptoms (somatic concern, unusual thought content, lack of judgment/insight). Each item is scored on a 7-point scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 8 to 56. Higher (positive) scores indicate worsening. Data show change from baseline to week 2.
Time frame: Baseline and Week 4
PANSS rates severity of psychopathology in patients with schizophrenia. The positive symptoms dimension is sum of 4 positive symptoms (delusions, hallucinatory behavior, grandiosity, suspiciousness/persecution), 1 negative symptom (stereotyped thinking), and 3 general psychopathology symptoms (somatic concern, unusual thought content, lack of judgment/insight). Each item is scored on a 7-point scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 8 to 56. Higher (positive) scores indicate worsening. Data show change from baseline to week 4.
Time frame: Baseline and Week 8
PANSS rates severity of psychopathology in patients with schizophrenia. The positive symptoms dimension is sum of 4 positive symptoms (delusions, hallucinatory behavior, grandiosity, suspiciousness/persecution), 1 negative symptom (stereotyped thinking), and 3 general psychopathology symptoms (somatic concern, unusual thought content, lack of judgment/insight). Each item is scored on a 7-point scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 8 to 56. Higher (positive) scores indicate worsening. Data show change from baseline to week 8.
Time frame: Baseline and Week 12
PANSS rates severity of psychopathology in patients with schizophrenia. The positive symptoms dimension is sum of 4 positive symptoms (delusions, hallucinatory behavior, grandiosity, suspiciousness/persecution), 1 negative symptom (stereotyped thinking), and 3 general psychopathology symptoms (somatic concern, unusual thought content, lack of judgment/insight). Each item is scored on a 7-point scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 8 to 56. Higher (positive) scores indicate worsening. Data show change from baseline to week 12.
Time frame: Baseline and Week 16
PANSS rates severity of psychopathology in patients with schizophrenia. The positive symptoms dimension is sum of 4 positive symptoms (delusions, hallucinatory behavior, grandiosity, suspiciousness/persecution), 1 negative symptom (stereotyped thinking), and 3 general psychopathology symptoms (somatic concern, unusual thought content, lack of judgment/insight). Each item is scored on a 7-point scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 8 to 56. Higher (positive) scores indicate worsening. Data show change from baseline to week 16.
Time frame: Baseline and Week 20
PANSS rates severity of psychopathology in patients with schizophrenia. The positive symptoms dimension is sum of 4 positive symptoms (delusions, hallucinatory behavior, grandiosity, suspiciousness/persecution), 1 negative symptom (stereotyped thinking), and 3 general psychopathology symptoms (somatic concern, unusual thought content, lack of judgment/insight). Each item is scored on a 7-point scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 8 to 56. Higher (positive) scores indicate worsening. Data show change from baseline to week 20.
Time frame: Baseline and Week 24
PANSS rates severity of psychopathology in patients with schizophrenia. The positive symptoms dimension is sum of 4 positive symptoms (delusions, hallucinatory behavior, grandiosity, suspiciousness/persecution), 1 negative symptom (stereotyped thinking), and 3 general psychopathology symptoms (somatic concern, unusual thought content, lack of judgment/insight). Each item is scored on a 7-point scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 8 to 56. Higher (positive) scores indicate worsening. Data show change from baseline to week 24.
Time frame: Baseline and Endpoint (Week 24 or last observation)
PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The anxiety/depression dimension is the sum of 4 general psychopathology symptoms (anxiety, guilt feelings, tension, depression). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to endpoint. Higher (positive) scores indicate worsening.
Time frame: Baseline and Week 1
PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The anxiety/depression dimension is the sum of 4 general psychopathology symptoms (anxiety, guilt feelings, tension, depression). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 1. Higher (positive) scores indicate worsening.
Time frame: Baseline and Week 2
PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The anxiety/depression dimension is the sum of 4 general psychopathology symptoms (anxiety, guilt feelings, tension, depression). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 2. Higher (positive) scores indicate worsening.
Time frame: Baseline and Week 4
PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The anxiety/depression dimension is the sum of 4 general psychopathology symptoms (anxiety, guilt feelings, tension, depression). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 4. Higher (positive) scores indicate worsening.
Time frame: Baseline and Week 8
PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The anxiety/depression dimension is the sum of 4 general psychopathology symptoms (anxiety, guilt feelings, tension, depression). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 8. Higher (positive) scores indicate worsening.
Time frame: Baseline and Week 12
PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The anxiety/depression dimension is the sum of 4 general psychopathology symptoms (anxiety, guilt feelings, tension, depression). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 12. Higher (positive) scores indicate worsening.
Time frame: Baseline and Week 16
PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The anxiety/depression dimension is the sum of 4 general psychopathology symptoms (anxiety, guilt feelings, tension, depression). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 16. Higher (positive) scores indicate worsening.
Time frame: Baseline and Week 20
PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The anxiety/depression dimension is the sum of 4 general psychopathology symptoms (anxiety, guilt feelings, tension, depression). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 20. Higher (positive) scores indicate worsening.
Time frame: Baseline and Week 24
PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The anxiety/depression dimension is the sum of 4 general psychopathology symptoms (anxiety, guilt feelings, tension, depression). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 24. Higher (positive) scores indicate worsening.
Time frame: Baseline and Endpoint (Week 24 or last observation)
PANSS rates severity of psychopathology in schizophrenic patients. Disorganized thought dimension is the sum of 1 positive symptom (conceptual disorganization), 1 negative symptom (difficulty in abstract thinking), and 5 general psychopathology symptoms (mannerisms/posturing, disorientation, poor attention, disturbance of volition, preoccupation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 7 to 49. Higher (positive) score indicates worsening. Data indicates change from baseline to endpoint.
Time frame: Baseline and Week 1
PANSS rates severity of psychopathology in schizophrenics. Disorganized thought dimension is the sum of 1 positive symptom (conceptual disorganization), 1 negative symptom (difficulty in abstract thinking), and 5 general psychopathology symptoms (mannerisms and posturing, disorientation, poor attention, disturbance of volition, preoccupation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 7 to 49. Higher (positive) score indicates worsening. Data indicates change from baseline to week 1.
Time frame: Baseline and Week 2
PANSS rates severity of psychopathology in schizophrenics. Disorganized thought dimension is the sum of 1 positive symptom (conceptual disorganization), 1 negative symptom (difficulty in abstract thinking), and 5 general psychopathology symptoms (mannerisms and posturing, disorientation, poor attention, disturbance of volition, preoccupation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 7 to 49. Higher (positive) score indicates worsening. Data indicates change from baseline to week 2.
Time frame: Baseline and Week 4
PANSS rates severity of psychopathology in schizophrenics. Disorganized thought dimension is the sum of 1 positive symptom (conceptual disorganization), 1 negative symptom (difficulty in abstract thinking), and 5 general psychopathology symptoms (mannerisms and posturing, disorientation, poor attention, disturbance of volition, preoccupation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 7 to 49. Higher (positive) score indicates worsening. Data indicates change from baseline to week 4.
Time frame: Baseline and Week 8
PANSS rates severity of psychopathology in schizophrenics. Disorganized thought dimension is the sum of 1 positive symptom (conceptual disorganization), 1 negative symptom (difficulty in abstract thinking), and 5 general psychopathology symptoms (mannerisms and posturing, disorientation, poor attention, disturbance of volition, preoccupation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 7 to 49. Higher (positive) score indicates worsening. Data indicates change from baseline to week 8.
Time frame: Baseline and Week 12
PANSS rates severity of psychopathology in schizophrenics. Disorganized thought dimension is the sum of 1 positive symptom (conceptual disorganization), 1 negative symptom (difficulty in abstract thinking), and 5 general psychopathology symptoms (mannerisms and posturing, disorientation, poor attention, disturbance of volition, preoccupation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 7 to 49. Higher (positive) score indicates worsening. Data indicates change from baseline to week 12.
Time frame: Baseline and Week 16
PANSS rates severity of psychopathology in schizophrenics. Disorganized thought dimension is the sum of 1 positive symptom (conceptual disorganization), 1 negative symptom (difficulty in abstract thinking), and 5 general psychopathology symptoms (mannerisms and posturing, disorientation, poor attention, disturbance of volition, preoccupation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 7 to 49. Higher (positive) score indicates worsening. Data indicates change from baseline to week 16.
Time frame: Baseline and Week 20
PANSS rates severity of psychopathology in schizophrenics. Disorganized thought dimension is the sum of 1 positive symptom (conceptual disorganization), 1 negative symptom (difficulty in abstract thinking), and 5 general psychopathology symptoms (mannerisms and posturing, disorientation, poor attention, disturbance of volition, preoccupation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 7 to 49. Higher (positive) score indicates worsening. Data indicates change from baseline to week 20.
Time frame: Baseline and Week 24
PANSS rates severity of psychopathology in schizophrenics. Disorganized thought dimension is the sum of 1 positive symptom (conceptual disorganization), 1 negative symptom (difficulty in abstract thinking), and 5 general psychopathology symptoms (mannerisms and posturing, disorientation, poor attention, disturbance of volition, preoccupation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 7 to 49. Higher (positive) score indicates worsening. Data indicates change from baseline to week 24.
Time frame: Baseline and Endpoint (Week 24 or last observation)
PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The hostility/excitement dimension is the sum of 2 positive symptoms (excitement, hostility) and 2 general psychopathology symptoms (uncooperativeness, poor impulse control). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to endpoint. Higher (positive) score indicates worsening.
Time frame: Baseline and Week 1
PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The hostility/excitement dimension is the sum of 2 positive symptoms (excitement, hostility) and 2 general psychopathology symptoms (uncooperativeness, poor impulse control). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 1. Higher (positive) score indicates worsening.
Time frame: Baseline and Week 2
PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The hostility/excitement dimension is the sum of 2 positive symptoms (excitement, hostility) and 2 general psychopathology symptoms (uncooperativeness, poor impulse control). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 2. Higher (positive) score indicates worsening.
Time frame: Baseline and Week 4
PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The hostility/excitement dimension is the sum of 2 positive symptoms (excitement, hostility) and 2 general psychopathology symptoms (uncooperativeness, poor impulse control). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 4. Higher (positive) score indicates worsening.
Time frame: Baseline and Week 8
PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The hostility/excitement dimension is the sum of 2 positive symptoms (excitement, hostility) and 2 general psychopathology symptoms (uncooperativeness, poor impulse control). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 8. Higher (positive) score indicates worsening.
Time frame: Baseline and Week 12
PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The hostility/excitement dimension is the sum of 2 positive symptoms (excitement, hostility) and 2 general psychopathology symptoms (uncooperativeness, poor impulse control). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 12. Higher (positive) score indicates worsening.
Time frame: Baseline and Week 16
PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The hostility/excitement dimension is the sum of 2 positive symptoms (excitement, hostility) and 2 general psychopathology symptoms (uncooperativeness, poor impulse control). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 16. Higher (positive) score indicates worsening.
Time frame: Baseline and Week 20
PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The hostility/excitement dimension is the sum of 2 positive symptoms (excitement, hostility) and 2 general psychopathology symptoms (uncooperativeness, poor impulse control). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 20. Higher (positive) score indicates worsening.
Time frame: Baseline and Week 24
PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The hostility/excitement dimension is the sum of 2 positive symptoms (excitement, hostility) and 2 general psychopathology symptoms (uncooperativeness, poor impulse control). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 24. Higher (positive) score indicates worsening.
Time frame: Baseline and Endpoint (Week 24 or last observation)
The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to endpoint in the CGI-S rating. A negative value indicates improvement.
Time frame: Baseline and Week 1
The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 1 in the CGI-S rating. A negative value indicates improvement.
Time frame: Baseline and Week 2
The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 2 in the CGI-S rating. A negative value indicates improvement.
Time frame: Baseline and Week 4
The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 4 in the CGI-S rating. A negative value indicates improvement.
Time frame: Baseline and Week 6
The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 6 in the CGI-S rating. A negative value indicates improvement.
Time frame: Baseline and Week 8
The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 8 in the CGI-S rating. A negative value indicates improvement.
Time frame: Baseline and Week 10
The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 10 in the CGI-S rating. A negative value indicates improvement.
Time frame: Baseline and Week 12
The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 12 in the CGI-S rating. A negative value indicates improvement.
Time frame: Baseline and Week 14
The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 14 in the CGI-S rating. A negative value indicates improvement.
Time frame: Baseline and Week 16
The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 16 in the CGI-S rating. A negative value indicates improvement.
Time frame: Baseline and Week 18
The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 18 in the CGI-S rating. A negative value indicates improvement.
Time frame: Baseline and Week 20
The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 20 in the CGI-S rating. A negative value indicates improvement.
Time frame: Baseline and Week 22
The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 22 in the CGI-S rating. A negative value indicates improvement.
Time frame: Baseline and Week 24
The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 24 in the CGI-S rating. A negative value indicates improvement.
Time frame: Baseline and Endpoint (Week 24 or last observation)
PSP is a validated clinician-rated assessment of functioning. Four areas of functioning (socially useful activities, personal/social relationships, self-care, disturbing/aggressive behaviors) are assessed on a 6-point scale (0=absent to 5=very severe). A transformed score from 1 to 100 is generated from the raw score based on the clinical interpretation of the scores generated in the 4 areas of functioning, with a higher transformed score indicating better function. Data presented here represents change from baseline to endpoint in the overall score with positive values signifying improvement.
Time frame: Baseline and Week 4
PSP is a validated clinician-rated assessment of functioning. Four areas of functioning (socially useful activities, personal/social relationships, self-care, disturbing/aggressive behaviors) are assessed on a 6-point scale (0=absent to 5=very severe). A transformed score from 1 to 100 is generated from the raw score based on the clinical interpretation of the scores generated in the 4 areas of functioning, with a higher transformed score indicating better function. Data presented here represents change from baseline to week 4 in the overall score with positive values signifying improvement.
Time frame: Baseline and Week 12
PSP is a validated clinician-rated assessment of functioning. Four areas of functioning (socially useful activities, personal/social relationships, self-care, disturbing/aggressive behaviors) are assessed on a 6-point scale (0=absent to 5=very severe). A transformed score from 1 to 100 is generated from the raw score based on the clinical interpretation of the scores generated in the 4 areas of functioning, with a higher transformed score indicating better function. Data presented here represents change from baseline to week 12 in the overall score with positive values signifying improvement.
Time frame: Baseline and Week 24
PSP is a validated clinician-rated assessment of functioning. Four areas of functioning (socially useful activities, personal/social relationships, self-care, disturbing/aggressive behaviors) are assessed on a 6-point scale (0=absent to 5=very severe). A transformed score from 1 to 100 is generated from the raw score based on the clinical interpretation of the scores generated in the 4 areas of functioning, with a higher transformed score indicating better function. Data presented here represents change from baseline to week 24 in the overall score with positive values signifying improvement.
Time frame: Baseline and Endpoint (Week 24 or last observation)
CNSVitalSigns cognitive battery consists of 4 tests (Verbal Memory, Symbol-Digit Coding Test, Shifting Attention Test, Continuous Performance Test [CPT]). With Verbal Memory Test, patient asked to remember 15 words within a field of 15 distractors immediately and after twenty minute delay. Score is the sum of correct immediate "hits", correct immediate "passes", correct delayed "hits", and correct delayed "passes". Total score may range from 0 to 60, with a higher score indicating more correct responses. Data represents change from baseline to endpoint, with positive score showing improvement.
Time frame: Baseline and Week 12
CNSVitalSigns cognitive battery consists of 4 tests (Verbal Memory, Symbol-Digit Coding Test, Shifting Attention Test, Continuous Performance Test [CPT]). With Verbal Memory Test, patient asked to remember 15 words within a field of 15 distractors immediately and after twenty minute delay. Score is the sum of correct immediate "hits", correct immediate "passes", correct delayed "hits", and correct delayed "passes". Total score may range from 0 to 60, with a higher score indicating more correct responses. Data represents change from baseline to week 12, with positive score showing improvement.
Time frame: Baseline and Week 24
CNSVitalSigns cognitive battery consists of 4 tests (Verbal Memory, Symbol-Digit Coding Test, Shifting Attention Test, Continuous Performance Test [CPT]). With Verbal Memory Test, patient asked to remember 15 words within a field of 15 distractors immediately and after twenty minute delay. Score is the sum of correct immediate "hits", correct immediate "passes", correct delayed "hits", and correct delayed "passes". Total score may range from 0 to 60, with a higher score indicating more correct responses. Data represents change from baseline to week 24, with positive score showing improvement.
Time frame: Baseline and Endpoint (Week 24 or last observation)
Symbol-digit coding test (SDCT) is one test in the CNSVitalSigns cognitive battery. SDCT assesses speed of processing. Subject is taught to link numbers to digits. The test consists of serial presentations of screens, each of which contains a bank of 8 symbols above and 8 empty boxes below. The subject types in the number that corresponds to the symbol highlighted. Scoring is the number of correct responses generated in 2 minutes. A higher score indicates greater processing speed. Data represents change from baseline to endpoint with positive values representing improvement.
Time frame: Baseline and Week 12
Symbol-digit coding test (SDCT) is one test in the CNSVitalSigns cognitive battery. SDCT assesses speed of processing. Subject is taught to link numbers to digits. The test consists of serial presentations of screens, each of which contains a bank of 8 symbols above and 8 empty boxes below. The subject types in the number that corresponds to the symbol highlighted. Scoring is the number of correct responses generated in 2 minutes. A higher score indicates greater processing speed. Data represents change from baseline to week 12 with positive values representing improvement.
Time frame: Baseline and Week 24
Symbol-digit coding test (SDCT) is one test in the CNSVitalSigns cognitive battery. SDCT assesses speed of processing. Subject is taught to link numbers to digits. The test consists of serial presentations of screens, each of which contains a bank of 8 symbols above and 8 empty boxes below. The subject types in the number that corresponds to the symbol highlighted. Scoring is the number of correct responses generated in 2 minutes. A higher score indicates greater processing speed. Data represents change from baseline to week 24 with positive values representing improvement.
Time frame: Baseline and Endpoint (Week 24 or last observation)
The Shifting Attention Test is a test in the CNSVitalSigns cognitive battery. The Shifting Attention Test assesses attention and executive function. Patients were instructed to match geometric objects either by shape or by color. Composite Scoring presented here was calculated as the number of correct responses minus the number of errors. A higher score indicates more correct responses. The data represent the change from baseline to endpoint and a positive value represents improvement.
Time frame: Baseline and Week 12
The Shifting Attention Test is a test in the CNSVitalSigns cognitive battery. The Shifting Attention Test assesses attention and executive function. Patients were instructed to match geometric objects either by shape or by color. Composite Scoring presented here was calculated as the number of correct responses minus the number of errors. A higher score indicates more correct responses. The data represent the change from baseline to week 12 and a positive value represents improvement.
Time frame: Baseline and Week 24
The Shifting Attention Test is a test in the CNSVitalSigns cognitive battery. The Shifting Attention Test assesses attention and executive function. Patients were instructed to match geometric objects either by shape or by color. Composite Scoring presented here was calculated as the number of correct responses minus the number of errors. A higher score indicates more correct responses. The data represent the change from baseline to week 24 and a positive value represents improvement.
Time frame: Baseline and Endpoint (Week 24 or last observation)
The 4-Part Continuous Performance Test (CPT) is a component of the CNSVitalSigns cognitive battery. The 4-Part CPT assesses working memory. The patient was presented with targets and had to remember target presentation sequencing in order to respond to the directions. The complexity of the directions increased as the patient proceeded through the 4 parts of the test. Scoring is based on the number of correct responses, with a higher number indicating more correct responses. Data represents change from baseline to endpoint with positive values demonstrating improvement.
Time frame: Baseline and Week 12
The 4-Part Continuous Performance Test (CPT) is a component of the CNSVitalSigns cognitive battery. The 4-Part CPT assesses working memory. The patient was presented with targets and had to remember target presentation sequencing in order to respond to the directions. The complexity of the directions increased as the patient proceeded through the 4 parts of the test. Scoring is based on the number of correct responses, with a higher number indicating more correct responses. Data represents change from baseline to week 12 with positive values demonstrating improvement.
Time frame: Baseline and Week 24
The 4-Part Continuous Performance Test (CPT) is a component of the CNSVitalSigns cognitive battery. The 4-Part CPT assesses working memory. The patient was presented with targets and had to remember target presentation sequencing in order to respond to the directions. The complexity of the directions increased as the patient proceeded through the 4 parts of the test. Scoring is based on the number of correct responses, with a higher number indicating more correct responses. Data represents change from baseline to week 24 with positive values demonstrating improvement.
Time frame: Baseline and Endpoint (Week 24 or last observation)
Abnormal Involuntary Movement Scale (AIMS) is a 14-item, clinician-rated scale to assess the severity of dyskinesias in patients taking neuroleptic drugs. Items 1 through 10 were rated using a 5-point (0-4) scale, items 11 through 14 were rated using a 2-point (no or yes) scale. The AIMS total score is the sum of items 1 through 10, and can range from 0-40. A higher score indicates a presence of more severe dyskinesias. Data represents change from baseline to endpoint, positive value represents worsening.
Time frame: Baseline and Week 1
Abnormal Involuntary Movement Scale (AIMS) is a 14-item, clinician-rated scale to assess the severity of dyskinesias in patients taking neuroleptic drugs. Items 1 through 10 were rated using a 5-point (0-4) scale, items 11 through 14 were rated using a 2-point (no or yes) scale. The AIMS total score is the sum of items 1 through 10, and can range from 0-40. A higher score indicates a presence of more severe dyskinesias. Data represents change from baseline to week 1, positive value represents worsening.
Time frame: Baseline and Week 2
Abnormal Involuntary Movement Scale (AIMS) is a 14-item, clinician-rated scale to assess the severity of dyskinesias in patients taking neuroleptic drugs. Items 1 through 10 were rated using a 5-point (0-4) scale, items 11 through 14 were rated using a 2-point (no or yes) scale. The AIMS total score is the sum of items 1 through 10, and can range from 0-40. A higher score indicates a presence of more severe dyskinesias. Data represents change from baseline to week 2, positive value represents worsening.
Time frame: Baseline and Week 4
Abnormal Involuntary Movement Scale (AIMS) is a 14-item, clinician-rated scale to assess the severity of dyskinesias in patients taking neuroleptic drugs. Items 1 through 10 were rated using a 5-point (0-4) scale, items 11 through 14 were rated using a 2-point (no or yes) scale. The AIMS total score is the sum of items 1 through 10, and can range from 0-40. A higher score indicates a presence of more severe dyskinesias. Data represents change from baseline to week 4, positive value represents worsening.
Time frame: Baseline and Week 8
Abnormal Involuntary Movement Scale (AIMS) is a 14-item, clinician-rated scale to assess the severity of dyskinesias in patients taking neuroleptic drugs. Items 1 through 10 were rated using a 5-point (0-4) scale, items 11 through 14 were rated using a 2-point (no or yes) scale. The AIMS total score is the sum of items 1 through 10, and can range from 0-40. A higher score indicates a presence of more severe dyskinesias. Data represents change from baseline to week 8, positive value represents worsening.
Time frame: Baseline and Week 12
Abnormal Involuntary Movement Scale (AIMS) is a 14-item, clinician-rated scale to assess the severity of dyskinesias in patients taking neuroleptic drugs. Items 1 through 10 were rated using a 5-point (0-4) scale, items 11 through 14 were rated using a 2-point (no or yes) scale. The AIMS total score is the sum of items 1 through 10, and can range from 0-40. A higher score indicates a presence of more severe dyskinesias. Data represents change from baseline to week 12, positive value represents worsening.
Time frame: Baseline and Week 16
Abnormal Involuntary Movement Scale (AIMS) is a 14-item, clinician-rated scale to assess the severity of dyskinesias in patients taking neuroleptic drugs. Items 1 through 10 were rated using a 5-point (0-4) scale, items 11 through 14 were rated using a 2-point (no or yes) scale. The AIMS total score is the sum of items 1 through 10, and can range from 0-40. A higher score indicates a presence of more severe dyskinesias. Data represents change from baseline to week 16, positive value represents worsening.
Time frame: Baseline and Week 20
Abnormal Involuntary Movement Scale (AIMS) is a 14-item, clinician-rated scale to assess the severity of dyskinesias in patients taking neuroleptic drugs. Items 1 through 10 were rated using a 5-point (0-4) scale, items 11 through 14 were rated using a 2-point (no or yes) scale. The AIMS total score is the sum of items 1 through 10, and can range from 0-40. A higher score indicates a presence of more severe dyskinesias. Data represents change from baseline to week 20, positive value represents worsening.
Time frame: Baseline and Week 24
Abnormal Involuntary Movement Scale (AIMS) is a 14-item, clinician-rated scale to assess the severity of dyskinesias in patients taking neuroleptic drugs. Items 1 through 10 were rated using a 5-point (0-4) scale, items 11 through 14 were rated using a 2-point (no or yes) scale. The AIMS total score is the sum of items 1 through 10, and can range from 0-40. A higher score indicates a presence of more severe dyskinesias. Data represents change from baseline to week 24, positive value represents worsening.
Time frame: Baseline and Endpoint (Week 24 or last observation)
The Simpson-Angus EPS Scale is a clinician-rated scale to assess parkinsonian and extrapyramidal symptoms (10 items) associated with antipsychotic medications. Each item is rated on a 5-point scale. In addition, this scale was used to evaluate and characterize adverse events of extrapyramidal symptoms. Total scores are calculated by summing the scores of each item (minimum 0, maximum 40) and dividing by the number of items (10). Scores can range from 0-4. A higher score indicates more severe symptoms. Data represents change from baseline to endpoint, positive values represent worsening.
Time frame: Baseline and Week 1
The Simpson-Angus EPS Scale is a clinician-rated scale to assess parkinsonian and extrapyramidal symptoms (10 items) associated with antipsychotic medications. Each item is rated on a 5-point scale. In addition, this scale was used to evaluate and characterize adverse events of extrapyramidal symptoms. Total scores are calculated by summing the scores of each item (minimum 0, maximum 40) and dividing by the number of items (10). Scores can range from 0-4. A higher score indicates more severe symptoms. Data represents change from baseline to week 1, positive values represent worsening.
Time frame: Baseline and Week 2
The Simpson-Angus EPS Scale is a clinician-rated scale to assess parkinsonian and extrapyramidal symptoms (10 items) associated with antipsychotic medications. Each item is rated on a 5-point scale. In addition, this scale was used to evaluate and characterize adverse events of extrapyramidal symptoms. Total scores are calculated by summing the scores of each item (minimum 0, maximum 40) and dividing by the number of items (10). Scores can range from 0-4. A higher score indicates more severe symptoms. Data represents change from baseline to week 2, positive values represent worsening.
Time frame: Baseline and Week 4
The Simpson-Angus EPS Scale is a clinician-rated scale to assess parkinsonian and extrapyramidal symptoms (10 items) associated with antipsychotic medications. Each item is rated on a 5-point scale. In addition, this scale was used to evaluate and characterize adverse events of extrapyramidal symptoms. Total scores are calculated by summing the scores of each item (minimum 0, maximum 40) and dividing by the number of items (10). Scores can range from 0-4. A higher score indicates more severe symptoms. Data represents change from baseline to week 4, positive values represent worsening.
Time frame: Baseline and Week 8
The Simpson-Angus EPS Scale is a clinician-rated scale to assess parkinsonian and extrapyramidal symptoms (10 items) associated with antipsychotic medications. Each item is rated on a 5-point scale. In addition, this scale was used to evaluate and characterize adverse events of extrapyramidal symptoms. Total scores are calculated by summing the scores of each item (minimum 0, maximum 40) and dividing by the number of items (10). Scores can range from 0-4. A higher score indicates more severe symptoms. Data represents change from baseline to week 8, positive values represent worsening.
Time frame: Baseline and Week 12
The Simpson-Angus EPS Scale is a clinician-rated scale to assess parkinsonian and extrapyramidal symptoms (10 items) associated with antipsychotic medications. Each item is rated on a 5-point scale. In addition, this scale was used to evaluate and characterize adverse events of extrapyramidal symptoms. Total scores are calculated by summing the scores of each item (minimum 0, maximum 40) and dividing by the number of items (10). Scores can range from 0-4. A higher score indicates more severe symptoms. Data represents change from baseline to week 12, positive values represent worsening.
Time frame: Baseline and Week 16
The Simpson-Angus EPS Scale is a clinician-rated scale to assess parkinsonian and extrapyramidal symptoms (10 items) associated with antipsychotic medications. Each item is rated on a 5-point scale. In addition, this scale was used to evaluate and characterize adverse events of extrapyramidal symptoms. Total scores are calculated by summing the scores of each item (minimum 0, maximum 40) and dividing by the number of items (10). Scores can range from 0-4. A higher score indicates more severe symptoms. Data represents change from baseline to week 16, positive values represent worsening.
Time frame: Baseline and Week 20
The Simpson-Angus EPS Scale is a clinician-rated scale to assess parkinsonian and extrapyramidal symptoms (10 items) associated with antipsychotic medications. Each item is rated on a 5-point scale. In addition, this scale was used to evaluate and characterize adverse events of extrapyramidal symptoms. Total scores are calculated by summing the scores of each item (minimum 0, maximum 40) and dividing by the number of items (10). Scores can range from 0-4. A higher score indicates more severe symptoms. Data represents change from baseline to week 20, positive values represent worsening.
Time frame: Baseline and Week 24
The Simpson-Angus EPS Scale is a clinician-rated scale to assess parkinsonian and extrapyramidal symptoms (10 items) associated with antipsychotic medications. Each item is rated on a 5-point scale. In addition, this scale was used to evaluate and characterize adverse events of extrapyramidal symptoms. Total scores are calculated by summing the scores of each item (minimum 0, maximum 40) and dividing by the number of items (10). Scores can range from 0-4. A higher score indicates more severe symptoms. Data represents change from baseline to week 24, positive values represent worsening.
Time frame: Baseline and Endpoint (Week 24 or last observation)
Barnes Akathisia Rating Scale (BARS) measures presence and severity of drug-induced akathisia. Items related to objective akathisia, subjective awareness of restlessness, and distress related to restlessness were rated using a 4-point scale: 0=normal/no distress, 1=presence of restlessness/mild distress, 2=observable restlessness/moderate distress, 3=constant restlessness/severe distress. Total score is sum of scores of each item and range from 0-9. Higher score indicates greater restlessness and distress. Data represent change from baseline to endpoint, positive values represent worsening.
Time frame: Baseline and Week 1
Barnes Akathisia Rating Scale (BARS) measures presence and severity of drug-induced akathisia. Items related to objective akathisia, subjective awareness of restlessness, and distress related to restlessness were rated using a 4-point scale: 0=normal/no distress, 1=presence of restlessness/mild distress, 2=observable restlessness/moderate distress, 3=constant restlessness/severe distress. Total score is sum of scores of each item and range from 0-9. Higher score indicates greater restlessness and distress. Data represent change from baseline to week 1, positive values represent worsening.
Time frame: Baseline and Week 2
Barnes Akathisia Rating Scale (BARS) measures presence and severity of drug-induced akathisia. Items related to objective akathisia, subjective awareness of restlessness, and distress related to restlessness were rated using a 4-point scale: 0=normal/no distress, 1=presence of restlessness/mild distress, 2=observable restlessness/moderate distress, 3=constant restlessness/severe distress. Total score is sum of scores of each item and range from 0-9. Higher score indicates greater restlessness and distress. Data represent change from baseline to week 2, positive values represent worsening.
Time frame: Baseline and Week 4
Barnes Akathisia Rating Scale (BARS) measures presence and severity of drug-induced akathisia. Items related to objective akathisia, subjective awareness of restlessness, and distress related to restlessness were rated using a 4-point scale: 0=normal/no distress, 1=presence of restlessness/mild distress, 2=observable restlessness/moderate distress, 3=constant restlessness/severe distress. Total score is sum of scores of each item and range from 0-9. Higher score indicates greater restlessness and distress. Data represent change from baseline to week 4, positive values represent worsening.
Time frame: Baseline and Week 8
Barnes Akathisia Rating Scale (BARS) measures presence and severity of drug-induced akathisia. Items related to objective akathisia, subjective awareness of restlessness, and distress related to restlessness were rated using a 4-point scale: 0=normal/no distress, 1=presence of restlessness/mild distress, 2=observable restlessness/moderate distress, 3=constant restlessness/severe distress. Total score is sum of scores of each item and range from 0-9. Higher score indicates greater restlessness and distress. Data represent change from baseline to week 8, positive values represent worsening.
Time frame: Baseline and Week 12
Barnes Akathisia Rating Scale (BARS) measures presence and severity of drug-induced akathisia. Items related to objective akathisia, subjective awareness of restlessness, and distress related to restlessness were rated using a 4-point scale: 0=normal/no distress, 1=presence of restlessness/mild distress, 2=observable restlessness/moderate distress, 3=constant restlessness/severe distress. Total score is sum of scores of each item and range from 0-9. Higher score indicates greater restlessness and distress. Data represent change from baseline to week 12, positive values represent worsening.
Time frame: Baseline and Week 16
Barnes Akathisia Rating Scale (BARS) measures presence and severity of drug-induced akathisia. Items related to objective akathisia, subjective awareness of restlessness, and distress related to restlessness were rated using a 4-point scale: 0=normal/no distress, 1=presence of restlessness/mild distress, 2=observable restlessness/moderate distress, 3=constant restlessness/severe distress. Total score is sum of scores of each item and range from 0-9. Higher score indicates greater restlessness and distress. Data represent change from baseline to week 16, positive values represent worsening.
Time frame: Baseline and Week 20
Barnes Akathisia Rating Scale (BARS) measures presence and severity of drug-induced akathisia. Items related to objective akathisia, subjective awareness of restlessness, and distress related to restlessness were rated using a 4-point scale: 0=normal/no distress, 1=presence of restlessness/mild distress, 2=observable restlessness/moderate distress, 3=constant restlessness/severe distress. Total score is sum of scores of each item and range from 0-9. Higher score indicates greater restlessness and distress. Data represent change from baseline to week 20, positive values represent worsening.
Time frame: Baseline and Week 24
Barnes Akathisia Rating Scale (BARS) measures presence and severity of drug-induced akathisia. Items related to objective akathisia, subjective awareness of restlessness, and distress related to restlessness were rated using a 4-point scale: 0=normal/no distress, 1=presence of restlessness/mild distress, 2=observable restlessness/moderate distress, 3=constant restlessness/severe distress. Total score is sum of scores of each item and range from 0-9. Higher score indicates greater restlessness and distress. Data represent change from baseline to week 24, positive values represent worsening.
Time frame: Baseline and Endpoint (Week 24 or last observation)
Calgary Depression Scale for Schizophrenia (CDSS) assesses the level of depression in patients with schizophrenia. Nine items (depression, hopelessness, self-depreciation, pathological guilt, guilty ideas of reference, morning depression, early awakening, suicidal, observed depression) are each scored on a 4-point scale: 0=absent, 1=mild, 2=moderate, 3=severe. The total score is a sum of the scores of each item and may range from 0 to 27. Higher score more severe pathology. Data presented here represents the change from baseline to endpoint, positive values represent worsening.
Time frame: Baseline and Week 1
Calgary Depression Scale for Schizophrenia (CDSS) assesses the level of depression in patients with schizophrenia. Nine items (depression, hopelessness, self-depreciation, pathological guilt, guilty ideas of reference, morning depression, early awakening, suicidal, observed depression) are each scored on a 4-point scale: 0=absent, 1=mild, 2=moderate, 3=severe. The total score is a sum of the scores of each item and may range from 0 to 27. Higher score more severe pathology. Data presented here represents the change from baseline to week 1, positive values represent worsening.
Time frame: Baseline and Week 2
Calgary Depression Scale for Schizophrenia (CDSS) assesses the level of depression in patients with schizophrenia. Nine items (depression, hopelessness, self-depreciation, pathological guilt, guilty ideas of reference, morning depression, early awakening, suicidal, observed depression) are each scored on a 4-point scale: 0=absent, 1=mild, 2=moderate, 3=severe. The total score is a sum of the scores of each item and may range from 0 to 27. Higher score more severe pathology. Data presented here represents the change from baseline to week 2, positive values represent worsening.
Time frame: Baseline and Week 4
Calgary Depression Scale for Schizophrenia (CDSS) assesses the level of depression in patients with schizophrenia. Nine items (depression, hopelessness, self-depreciation, pathological guilt, guilty ideas of reference, morning depression, early awakening, suicidal, observed depression) are each scored on a 4-point scale: 0=absent, 1=mild, 2=moderate, 3=severe. The total score is a sum of the scores of each item and may range from 0 to 27. Higher score more severe pathology. Data presented here represents the change from baseline to week 4, positive values represent worsening.
Time frame: Baseline and Week 8
Calgary Depression Scale for Schizophrenia (CDSS) assesses the level of depression in patients with schizophrenia. Nine items (depression, hopelessness, self-depreciation, pathological guilt, guilty ideas of reference, morning depression, early awakening, suicidal, observed depression) are each scored on a 4-point scale: 0=absent, 1=mild, 2=moderate, 3=severe. The total score is a sum of the scores of each item and may range from 0 to 27. Higher score more severe pathology. Data presented here represents the change from baseline to week 8, positive values represent worsening.
Time frame: Baseline and Week 12
Calgary Depression Scale for Schizophrenia (CDSS) assesses the level of depression in patients with schizophrenia. Nine items (depression, hopelessness, self-depreciation, pathological guilt, guilty ideas of reference, morning depression, early awakening, suicidal, observed depression) are each scored on a 4-point scale: 0=absent, 1=mild, 2=moderate, 3=severe. The total score is a sum of the scores of each item and may range from 0 to 27. Higher score more severe pathology. Data presented here represents the change from baseline to week 12, positive values represent worsening.
Time frame: Baseline and Week 16
Calgary Depression Scale for Schizophrenia (CDSS) assesses the level of depression in patients with schizophrenia. Nine items (depression, hopelessness, self-depreciation, pathological guilt, guilty ideas of reference, morning depression, early awakening, suicidal, observed depression) are each scored on a 4-point scale: 0=absent, 1=mild, 2=moderate, 3=severe. The total score is a sum of the scores of each item and may range from 0 to 27. Higher score more severe pathology. Data presented here represents the change from baseline to week 16, positive values represent worsening.
Time frame: Baseline and Week 20
Calgary Depression Scale for Schizophrenia (CDSS) assesses the level of depression in patients with schizophrenia. Nine items (depression, hopelessness, self-depreciation, pathological guilt, guilty ideas of reference, morning depression, early awakening, suicidal, observed depression) are each scored on a 4-point scale: 0=absent, 1=mild, 2=moderate, 3=severe. The total score is a sum of the scores of each item and may range from 0 to 27. Higher score more severe pathology. Data presented here represents the change from baseline to week 20, positive values represent worsening.
Time frame: Baseline and Week 24
Calgary Depression Scale for Schizophrenia (CDSS) assesses the level of depression in patients with schizophrenia. Nine items (depression, hopelessness, self-depreciation, pathological guilt, guilty ideas of reference, morning depression, early awakening, suicidal, observed depression) are each scored on a 4-point scale: 0=absent, 1=mild, 2=moderate, 3=severe. The total score is a sum of the scores of each item and may range from 0 to 27. Higher score more severe pathology. Data presented here represents the change from baseline to week 24, positive values represent worsening.
Time frame: Endpoint (Week 24 or last observation)
The C-SSRS was performed at weeks 8, 16, and 24 (or last observation after baseline), and at any time if clinically indicated. The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The data presented here represents the percentage of patients in each arm found to have suicidal behavior in the judgment of a clinician and based upon a clinicians interpretation of the subject's responses to the C-SSRS questions.
Time frame: Week 8
The C-SSRS was performed at weeks 8, 16, and 24 (or last observation after baseline), and at any time if clinically indicated. The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The data presented here represents the percentage of patients in each arm found to have suicidal behavior at week 8 in the judgment of a clinician and based upon a clinicians interpretation of the subject's responses to the C-SSRS questions.
Time frame: Week 16
The C-SSRS was performed at weeks 8, 16, and 24 (or last observation after baseline), and at any time if clinically indicated. The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The data presented here represents the percentage of patients in each arm found to have suicidal behavior in the judgment of a clinician and based upon a clinicians interpretation of the subject's responses to the C-SSRS questions at week 16.
Time frame: Week 24
The C-SSRS was performed at weeks 8, 16, and 24 (or last observation after baseline), and at any time if clinically indicated. The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The data presented here represents the percentage of patients in each arm found to have suicidal behavior in the judgment of a clinician and based upon a clinicians interpretation of the subject's responses to the C-SSRS questions at week 24.
Time frame: Endpoint (Week 24 or last observation)
The C-SSRS was performed at weeks 8, 16, and 24 (or last observation after baseline), and at any time if clinically indicated. The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The data presented here represents the percentage of patients in each arm found to have suicidal ideation in the judgment of a clinician and based upon a clinicians interpretation of the subject's responses to the C-SSRS questions at endpoint.
Time frame: Week 8
The C-SSRS was performed at weeks 8, 16, and 24 (or last observation after baseline), and at any time if clinically indicated. The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The data presented here represents the percentage of patients in each arm found to have suicidal ideation in the judgment of a clinician and based upon a clinicians interpretation of the subject's responses to the C-SSRS questions at week 8.
Time frame: Week 16
The C-SSRS was performed at weeks 8, 16, and 24 (or last observation after baseline), and at any time if clinically indicated. The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The data presented here represents the percentage of patients in each arm found to have suicidal ideation in the judgment of a clinician and based upon a clinicians interpretation of the subject's responses to the C-SSRS questions at week 16.
Time frame: Week 24
The C-SSRS was performed at weeks 8, 16, and 24 (or last observation after baseline), and at any time if clinically indicated. The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The data presented here represents the percentage of patients in each arm found to have suicidal ideation in the judgment of a clinician and based upon a clinicians interpretation of the subject's responses to the C-SSRS questions at week 24.
Time frame: Baseline and Endpoint (Week 24 or last observation)
A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency (time till fall asleep), duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to endpoint in reported sleep latency. There is no range of possible values, positive values represent prolongation of sleep latency.
Time frame: Baseline and Week 12
A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency (time till fall asleep), duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to week 12 in reported sleep latency. There is no range of possible values, positive values represent prolongation of sleep latency.
Time frame: Baseline and Week 24
A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency (time till fall asleep), duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to week 24 in reported sleep latency. There is no range of possible values, positive values represent prolongation of sleep latency.
Time frame: Baseline and Endpoint (Week 24 or last observation)
A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to endpoint in reported number of nighttime awakenings. A positive value represents an increase in number of night time awakenings.
Time frame: Baseline and Week 12
A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to week 12 in reported number of nighttime awakenings. A positive value represents an increase in number of night time awakenings.
Time frame: Baseline and Week 24
A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to week 24 in reported number of nighttime awakenings. A positive value represents an increase in number of night time awakenings.
Time frame: Baseline and Endpoint (Week 24 or last observation)
A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to endpoint in reported time spent awake at night. A positive value represents longer period awake at night.
Time frame: Baseline and Week 12
A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to week 12 in reported time spent awake at night. A positive value represents longer period awake at night.
Time frame: Baseline and Week 24
A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to week 24 in reported time spent awake at night. A positive value represents longer period awake at night.
Time frame: Baseline and Endpoint (Week 24 or last observation)
A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to endpoint in reported time spent asleep at night. A positive value indicates increased time spent asleep at night.
Time frame: Baseline and Week 12
A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to week 12 in reported time spent asleep at night. A positive value indicates increased time spent asleep at night.
Time frame: Baseline and Week 24
A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to week 24 in reported time spent asleep at night. A positive value indicates increased time spent asleep at night.
Time frame: Baseline and Endpoint (Week 24 or last observation)
A sleep questionnaire was used to evaluate the effect of armodafinil on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to endpoint in participants' ratings of their quality of sleep as measured on a 4-point scale (1=Poor, 2=Fair, 3=Good, 4=Excellent). A positive value represents improvement in sleep quality.
Time frame: Baseline and Week 12
A sleep questionnaire was used to evaluate the effect of armodafinil on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to week 12 in participants' ratings of their quality of sleep as measured on a 4-point scale (1=Poor, 2=Fair, 3=Good, 4=Excellent). A positive value represents improvement in sleep quality.
Time frame: Baseline and Week 24
A sleep questionnaire was used to evaluate the effect of armodafinil on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to week 24 in participants' ratings of their quality of sleep as measured on a 4-point scale (1=Poor, 2=Fair, 3=Good, 4=Excellent). A positive value represents improvement in sleep quality.
Cephalon
Industry
A 24-Week, Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dosage Study to Evaluate the Efficacy and Safety of Armodafinil (150, 200, and 250 mg/ Day) as Adjunctive Therapy in Adults With Schizophrenia
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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