Efficacy Study of Early Onset of Antipsychotic Drug Action in Schizophrenia

Official Title: “Predicting Response to Risperidone Treatment Through Identification 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.

Intervention(s) in this Clinical Trial

• Drug: olanzapine
  • 10-20 milligrams (mg), oral, daily, 10 weeks.
• Drug: risperidone
  • 2-6 mg, oral, daily, for 10 weeks.
• Drug: risperidone
  • 2-6 mg, oral, daily, 10 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Olanzapine for Not Early Onset response (NEO) patients
• Active Comparator: 2
  • Risperidone for Not Early Onset response (NEO) patients
• Active Comparator: 3
  • Risperidone for Early Onset response (EO) patients

Primary Measures

• 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
    Safety Issue?: No

Secondary Measures

• 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
    Safety Issue?: No
• 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
    Safety Issue?: No
• 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
    Safety Issue?: No
• 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
    Safety Issue?: No
• 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
    Safety Issue?: No
• Number of Participants With Psychiatric Hospitalizations in the Early Onset and Not Early Onset-Risperidone Groups
  • Time Frame: Week 2 to Week 12
    Safety Issue?: No
• Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Body Mass Index
  • Time Frame: Week 2 to Week 12
    Safety Issue?: Yes
• Number of Participants With Treatment-Emergent Abnormal Fasting Laboratory Analytes Reported in >=2% of All Participants
  • Time Frame: Week 2 to Week 12
    Safety Issue?: Yes
• 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
    Safety Issue?: Yes
• 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
    Safety Issue?: Yes
• 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
    Safety Issue?: Yes
• Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Sitting Pulse Rate
  • Time Frame: Week 2 and Week 12
    Safety Issue?: Yes
• Vital Signs - Change From Baseline to 10 Week Endpoint in Standing Diastolic Blood Pressure
  • Time Frame: Week 2 and Week 12
    Safety Issue?: Yes
• Vital Signs - Change From Baseline to 10 Week Endpoint in Standing Mean Arterial Pressure
  • Time Frame: Week 2 and Week 12
    Safety Issue?: Yes
• Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Standing Pulse Rate
  • Time Frame: Week 2 and Week 12
    Safety Issue?: Yes
• Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Standing Systolic Blood Pressure
  • Time Frame: Week 2 and Week 12
    Safety Issue?: Yes
• Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Body Weight
  • Time Frame: Week 2 and Week 12
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Eli Lilly and Company Industry

Overall Clinical Trial Officials and Contacts

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Study Director Eli Lilly and Company  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00337662

Study ID Number: 10769

ClinicalTrials.gov Identifier: NCT00337662

Health Authority: United States: Food and Drug Administration

Lilly Clinical Trial Registry