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OpenTrials
Completed

NCT Number: NCT01086748

A Study in Schizophrenia Patients

An inpatient/outpatient study to see if LY2140023 is better than placebo in acutely ill patients with schizophrenia.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

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., Zagreb, Croatia

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of schizophrenia as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR; APA 2000) (Disorganized, 295.10; Catatonic, 295.20; Paranoid 295.30; or Undifferentiated, 295.90) and confirmed by the Structured Clinical Interview for DSM-IV-TR (SCID).
  • Non pregnant female patients who agree to use acceptable birth control
  • At entry to the study must be considered moderately ill in the opinion of the investigator
  • Willing to participate in a minimum of 3 weeks of inpatient hospitalization and this must be appropriate for the patient in the clinical judgment of the investigator.
  • 1 year history of Schizophrenia prior to entering the study
  • At study entry patients with a history of antipsychotic treatment must have a lifetime history of at least one hospitalization for the treatment of schizophrenia, not including the hospitalization required for study. Patients who have never taken antipsychotic treatment may enter the study even without a history of hospitalization.
  • At study entry patients with a history of antipsychotic treatment must have a history of at least one episode of illness exacerbation requiring an intensification of treatment intervention or care in the last 2 years, not including the present episode of illness. Patients who have never taken antipsychotic treatment may enter the study without a past history of illness exacerbation and intensification of treatment in the last 2 years.
  • At study entry patients must have experienced an exacerbation of illness within the 2 weeks prior to entering the study, leading to an intensification of psychiatric care in the opinion of the investigator. If exacerbation occurs in patients who are presently hospitalized, the patient must not have been hospitalized longer than 60 days at entry of the study

Exclusion criteria

  • Participated in any clinical trial with any pharmacological treatment intervention for which they received a study-related medication in the 6 months prior to visit 1
  • Previously completed or withdrawn from this study, or any other study investigating LY2140023 or any predecessor molecules with glutamatergic activity.
  • Treatment with clozapine at doses greater than 200 mg daily within 12 months prior to entering the study, or who have received any clozapine at all during the month before entering the study
  • Patients currently receiving treatment (within 1 dosing interval, minimum of 4 weeks, prior entering the study) with a depot formulation of an antipsychotic medication.
  • Patients who are currently suicidal.
  • Females who are pregnant, nursing, or who intend to become pregnant within 30 days of completing the study.
  • Patients with uncorrected narrow-angle glaucoma, uncontrolled diabetes, certain diseases of the liver, renal insufficiency, uncontrolled thyroid condition or other serious or unstable illnesses
  • Have a history of one or more seizures, except for those who experienced a single simple febrile seizure between ages 6 months and 5 years
  • Patients are excluded if their, biological father, mother, brother, sister, or child has a history of idiopathic epilepsy.
  • Within 1 year of study enrollment, patients have a history of central nervous system infection, uncontrolled migraine, transient ischemic attack (TIA), or head trauma with loss of consciousness or a post-concussive
  • Patients are excluded if they have a lifetime history of any of the following:
  • head trauma, stroke, or CNS infection with persistent neurological deficit (focal or diffuse);
  • brain surgery;
  • an electroencephalogram with paroxysmal (epileptiform) activity, or
  • brain structural lesion, including developmental abnormalities, as determined by examination or previous neuroimaging studies that are consistent with a diagnosable neurological disease or syndrome.
  • Electroconvulsive therapy (ECT) within 3 months of entering the study or who will have ECT at any time during the study.
  • Leukopenia
  • Medical history of Human Immunodeficiency Virus positive (HIV+) status.
  • Higher than normal blood prolactin levels
  • Certain electrocardiogram results

Treatment and study plan

Risperidone

Drug

Administered orally.

Placebo

Drug

Administered orally.

LY2140023

Drug

Administered orally.

Primary outcomes

  1. A change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score in overall schizophrenia population

    Time frame: baseline, up to 7 weeks of treatment

  2. A change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score in a genetic subgroup of schizophrenia patients

    Time frame: baseline, up to 7 weeks of treatment

Secondary outcomes

  1. A change from baseline in the Personal and Social Performance (PSP) score in the overall schizophrenia population

    Time frame: baseline, up to 7 weeks of treatment

  2. A change from baseline in the Personal and Social Performance (PSP) score in a genetic subgroup of schizophrenia patients

    Time frame: baseline, up to 7 weeks of treatment

  3. A change from baseline in the PANSS positive scale

    Time frame: baseline, up to 7 weeks of treatment

  4. A change from baseline in the PANSS negative scale

    Time frame: baseline, up to 7 weeks of treatment

  5. A change from baseline in PANSS General Psychopathology subscale

    Time frame: baseline, up to 7 weeks of treatment

  6. A change from baseline in the Clinical Global Impression-Severity Scale (CGI-S)

    Time frame: baseline, up to 7 weeks of treatment

  7. A change from baseline in the 16-item Negative Symptoms Assessment (NSA-16)

    Time frame: baseline, up to 7 weeks of treatment

  8. A change from baseline in the Montgomery-Ǻsberg Depression Rating Scale (MADRS)

    Time frame: baseline, up to 7 weeks of treatment

  9. PANSS total score

    Time frame: up to 7 weeks of treatment

  10. A change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score in a female patients

    Time frame: baseline, up to 7 weeks of treatment

  11. Rate of discontinuation

    Time frame: baseline, up to 7 weeks of treatment

  12. Time to discontinuation

    Time frame: baseline, up to 7 weeks of treatment

  13. A change from baseline on the EuroQol - 5 Dimensions (EQ-5D) Questionnaire

    Time frame: baseline, up to 7 weeks of treatment

  14. A change from baseline on resource utilization, as measured by the Schizophrenia Resource Use Model (S-RUM)

    Time frame: Baseline up to 7 weeks of treatment

  15. A change from baseline on functional capacity, as measured by the Subjective Well-Being Under Neuroleptic Treatment Scale - Short Form (SWN-S)

    Time frame: baseline, up to 7 weeks of treatment

  16. A change from baseline in Barnes Akathisia Scale (BAS)

    Time frame: baseline, up to 7 weeks of treatment

  17. A change from baseline in Simpson-Angus Scale (SAS)

    Time frame: baseline, up to 7 weeks of treatment

  18. A change from baseline in Abnormal Involuntary Movement Scale (AIMS)

    Time frame: baseline, up to 7 weeks of treatment

  19. A mean change from baseline in Prolactin levels

    Time frame: baseline, up to 7 weeks of treatment

  20. A change from baseline in weight

    Time frame: baseline, up to 7 weeks of treatment

  21. Number of Treatment Emergent Adverse Events (TEAEs)

    Time frame: Up to 7 weeks of treatment

  22. Change from baseline in electrocardiogram parameters

    Time frame: baseline, up to 7 weeks of treatment

  23. A change from baseline in neurological examination

    Time frame: baseline, up to 7 weeks of treatment

  24. Statistically different changes in vital signs from baseline

    Time frame: baseline, up to 7 weeks of treatment

  25. Statistically different changes in lab values from baseline

    Time frame: baseline, up to 7 weeks of treatment

  26. Population pharmacokinetics (PK) of LY2140023

    Time frame: baseline, up to 7 weeks of treatment

  27. A change from baseline in Columbia- Suicide Severity Rating Scale (C-SSRS)

    Time frame: baseline, up to 7 weeks of treatment

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Phase 2, Multicenter, Double-Blind, Placebo-Controlled Comparator Study of 2 Doses of LY2140023 Versus Placebo in Patients With DSM-IV-TR Schizophrenia

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Mar 15, 2010
Registry last updated
Sep 25, 2012

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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