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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: December 2007

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • olanzapine for NEO patients.
• Active Comparator: 2
  • Risperidone for NEO patients
• Active Comparator: 3
  • Risperidone for EO patients

Primary Measures

• Determine if early onset (EO) response to risperidone is linked to greater subsequent improvement in psychopathology as measured by comparison of PANSS total scores between risperidone-treated patients meeting EO criterion compared to those who do not.
  • Time Frame: Visit 5 to 9 (9 weeks)
    Safety Issue?: No

Secondary Measures

• Compare mean changes in psychopathology as measured from a repeated measures analysis of PANSS total score in No Early Onset (NEO) patients who remain on risperidone (NEO-RIS) to NEO patients switched to olanzapine (NEO-OLZ).
  • Time Frame: Visit 5 to 9 (9 weeks)
    Safety Issue?: No
• To compare the proportion of patients in the EO and NEO-RIS groups who show a 20% or greater reduction in PANSS total score.
  • Time Frame: Visit 2 to 9 (12 weeks)
    Safety Issue?: No
• To compare the proportion of patients in the NEO-RIS and NEO-OLZ groups who show a 20% or greater reduction in PANSS total score.
  • Time Frame: Visit 2 to 9 (12 weeks)
    Safety Issue?: No
• To compare the proportion of patients in the EO and NEO-RIS groups who show a 50% or greater reduction in PANSS total score from baseline or meet 'a priori' specified criteria for remission.
  • Time Frame: Visit 4 to 9 (10 weeks)
    Safety Issue?: No
• To compare the proportion of patients in the NEO-RIS and NEO-OLZ groups who show a 50% or greater reduction in PANSS total score from baseline or meet 'a priori' specified criteria for remission.
  • Time Frame: Visit 4 to 9 (10 weeks)
    Safety Issue?: No
• To compare the proportion of psychiatric hospitalizations for patients in the EO and NEO-RIS groups, as measured by the modified SCAP-HQ.
  • Time Frame: Visit 4 to 9 (10 weeks)
    Safety Issue?: No
• To compare the safety of olanzapine and risperidone therapies among the three treatment groups using treatment emergent adverse events.
  • Time Frame: Visit 4 to 9 (10 weeks)
    Safety Issue?: Yes
• To compare the safety of olanzapine and risperidone therapies among the three treatment groups using vital signs.
  • Time Frame: Visit 4 to 9 (10 weeks)
    Safety Issue?: Yes
• To compare the safety of olanzapine and risperidone therapies among the three treatment groups using fasting laboratory analytes.
  • Time Frame: Visit 4 to 9 (10 weeks)
    Safety Issue?: Yes
• To compare the safety of olanzapine and risperidone therapies among the three treatment groups using extrapyramidal symptoms as measured by the Modified Simpson-Angus Scale.
  • Time Frame: Visit 4 to 9 (10 weeks)
    Safety Issue?: Yes
• To compare the safety of olanzapine and risperidone therapies among the three treatment groups using extrapyramidal symptoms as measured by the Barnes Akathisia Rating Scale.
  • Time Frame: Visit 4 to 9 (10 weeks)
    Safety Issue?: Yes
• To compare the safety of olanzapine and risperidone therapies among the three treatment groups using extrapyramidal symptoms as measured by the Abnormal Involuntary Movement Scale (AIMS).
  • Time Frame: Visit 4 to 9 (10 weeks)
    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 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 Sponsor: Eli Lilly and Company

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 July 02, 2009

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