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Completed

NCT Number: NCT00337662

Efficacy Study of Early Onset of Antipsychotic Drug Action in Schizophrenia

The current study has been designed to address the significance of early onset of response prospectively in patients treated with an atypical antipsychotic.

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Key information

Conditions

Schizophrenia Mental Disorders Psychotic Disorders Schizoaffective Disorder Schizophrenia Spectrum and Other Psychotic Disorders Schizophreniform Disorder

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients must demonstrate acute psychopathologic severity criteria and be at least moderately ill.
  • Patients must have experienced an exacerbation of their illness within the previous 2 weeks.
  • Patients in whom a switch to another antipsychotic medication is acutely indicated.

Exclusion criteria

  • Patients who are deemed nonresponsive to risperidone or olanzapine.
  • Patients who have been hospitalized for greater than 2 weeks immediately prior to Visit 1.
  • Patients having received olanzapine or risperidone in the past 30 days.
  • Treatment with clozapine within 1 year prior to Visit 1.
  • Diagnosis of substance-induced psychosis by Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria within 7 days of Visit 1 (or at any time during the study), or confirmed on clinical grounds within 72 hours subsequent to Visit 1 (or at any time during the study).
  • A diagnosis of Parkinson's disease, dementia-related psychosis, or related disorders.

Treatment and study plan

Olanzapine

Drug

10-20 milligrams (mg), oral, daily, 10 weeks.

Other names: LY170053, Zyprexa

Risperidone

Drug

2-6 mg, oral, daily, for 10 weeks.

Primary outcomes

  1. Changes From Study Period II Baseline (Week 0) to Weeks 3, 4, 6, 8, and 12 in Positive and Negative Syndrome Scale (PANSS) Total Score in Early Onset Response and Not Early Onset Response-Risperidone Patients

    Time frame: Weeks 0, 3, 4, 6, 8, 12

    Assesses positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. Scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Sum of 30 items is PANSS total score and ranges from 30 to 210. Change = time point - single-blind baseline (Week 0).

Secondary outcomes

  1. Changes From Study Period III Baseline (Week 2) to Weeks 3, 4, 6, 8, and 12 in Positive and Negative Syndrome Scale Total Score in Not Early Onset Response-Risperidone and Not Early Onset Response-Olanzapine Patients

    Time frame: Weeks 2, 3, 4, 6, 8, 12

    Assesses positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. Scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Sum of 30 items is PANSS total score and ranges from 30 to 210. Change = time point - double-blind baseline (Week 2).

  2. The Number of Participants in the Early Onset (EO) and Not Early Onset-Risperidone (NEO-RIS) Groups Who Show a 20% or Greater Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score

    Time frame: Week 0 to Week 12

    The number of participants who experienced a 20% or greater reduction in their PANSS Total score during the 12 weeks they were on risperidone.

  3. The Number of Participants in the Not Early Onset-Risperidone (NEO-RIS) and Not Early Onset-Olanzapine (NEO-OLZ) Groups Who Show a 20% or Greater Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score

    Time frame: Week 0 to Week 12

    The number of not early onset participants who experienced a 20% or greater reduction in PANSS Total Score at any time during the 12 weeks of combined Study Period II and Study Period III.

  4. Number of Participants in the Early Onset and Not Early Onset-Risperidone Groups Who Show a 50% or Greater Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score From Baseline or Meet 'a Priori' Specified Criteria for Remission

    Time frame: Week 0 to Week 12

    'a priori' specified criteria for remission defined as a score of 3 (mild), 2 (minimal), or 1 (absent) on all of the following 8 PANSS items: delusions, conceptual disorganization, hallucinatory behavior, unusual thought content, mannerisms and posturing, blunted effect, passive/apathetic withdrawal, lack of spontaneity and flow of conversation.

  5. Number of Participants in the Not Early Onset-Risperidone and Not Early Onset-Olanzapine Groups Who Show a 50% or Greater Reduction in Positive and Negative Syndrome Scale Total Score From Baseline or Meet 'a Priori' Specified Criteria for Remission

    Time frame: Week 2 to Week 12

    'a priori' specified criteria for remission defined as a score of 3 (mild), 2 (minimal), or 1 (absent) on all of the following 8 PANSS items: delusions, conceptual disorganization, hallucinatory behavior, unusual thought content, mannerisms and posturing, blunted effect, passive/apathetic withdrawal, lack of spontaneity and flow of conversation.

  6. Number of Participants With Psychiatric Hospitalizations in the Early Onset and Not Early Onset-Risperidone Groups

    Time frame: Week 2 to Week 12

    Psychiatric Hospitalizations were measured by the Modified Schizophrenia Care and Assessment Program Health Questionnaire (SCAP-HQ) from which it could be determined the number of patients with a psychiatric episode that required an overnight stay in a hospital.

  7. Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Body Mass Index

    Time frame: Week 2 to Week 12

    Body mass index is an estimate of body fat based on body weight divided by height squared. Change = Endpoint minus baseline.

  8. Number of Participants With Treatment-Emergent Abnormal Fasting Laboratory Analytes Reported in >=2% of All Participants

    Time frame: Week 2 to Week 12

    Number of participants who experienced abnormal fasting laboratory values at any time during Study Period III. Laboratory reference ranges are dependent on the patient's gender, origin, and age.

  9. Mean Change From Baseline to 10 Week Endpoint in Extrapyramidal Symptoms as Measured by the Modified Simpson-Angus Scale

    Time frame: Week 2 to Week 12

    Measures neuroleptic-induced parkinsonism. Total score consists of the sum of 10 items: 7 items (items 1, 3, 4, 7, 8, 9, 10) rated on a 4-point severity scale where 0=normal and 4=extreme, and 3 items (items 2, 5, 6) rated on a 2-point severity scale where 0=normal and 2=definitely abnormal/present. The total score ranges from 0 to 34.

  10. Mean Change From Baseline to 10 Week Endpoint in Extrapyramidal Symptoms as Measured by the Barnes Akathisia Rating Scale - Total Score

    Time frame: Week 2 to Week 12

    Evaluates akathisia associated with use of antipsychotic medications, includes objective and subjective component plus global impression rating for overall disorder. Components rated on scale of 0 to 3 for objective and subjective items and 0 to 5 for global clinical assessment, for total score of 0 (absence of akathisia) to 11 (severe akathisia).

  11. Mean Change From Baseline to 10 Week Endpoint in Extrapyramidal Symptoms as Measured by the Abnormal Involuntary Movement Scale (AIMS)- Non-Global Total Score

    Time frame: Week 2 to Week 12

    A 12-item instrument assesses observed abnormal movements in different parts of body. Ten items are scored in a 5-point scale (0 = none/normal, 4 = severe) which evaluates abnormal movements in three main anatomic areas (orofacial area, extremities, and trunk). Two items are yes/no questions regarding dentures. Total scores range from 0 to 42.

  12. Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Sitting Pulse Rate

    Time frame: Week 2 and Week 12

    Changes from Study Period III baseline to endpoint in sitting pulse rate. Change = Endpoint minus baseline.

  13. Vital Signs - Change From Baseline to 10 Week Endpoint in Standing Diastolic Blood Pressure

    Time frame: Week 2 and Week 12

    Change from Study Period III baseline to endpoint in standing blood pressure. Change = Endpoint minus baseline.

  14. Vital Signs - Change From Baseline to 10 Week Endpoint in Standing Mean Arterial Pressure

    Time frame: Week 2 and Week 12

    Change from Study Period III baseline to endpoint in standing mean arterial pressure. Change = Endpoint minus baseline.

  15. Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Standing Pulse Rate

    Time frame: Week 2 and Week 12

    Change from Study Period III baseline to endpoint in standing pulse rate. Change = Endpoint minus baseline.

  16. Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Standing Systolic Blood Pressure

    Time frame: Week 2 and Week 12

    Change from Study Period III baseline to endpoint in standing systolic blood pressure. Change = Endpoint minus baseline.

  17. Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Body Weight

    Time frame: Week 2 and Week 12

    Change from Study Period III baseline to endpoint in body weight. Change = Endpoint minus baseline.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Predicting Response to Risperidone Treatment Through Identification of Early-onset of Antipsychotic Drug Action in Schizophrenia.

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Jun 16, 2006
Registry last updated
Feb 17, 2010

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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