Trial of Olanzapine in Patients With Manic or Mixed Episode of Bipolar I Disorder

Verified by: Eli Lilly and Company, December 2010
First Received: August 8, 2005 | Last Updated: December 10, 2010 | Phase: Phase 3 | Start Date: July 2005
Overall Status: Completed | Estimated Enrollment: 224
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The purpose of this study is to confirm the efficacy of olanzapine in the treatment of manic or mixed symptoms associated with bipolar I disorder...

Brief Summary

Official Title: “Placebo- and Haloperidol-Controlled Double-Blind Trial of Olanzapine in Patients With Manic or Mixed Episode of Bipolar I Disorder”

The purpose of this study is to confirm the efficacy of olanzapine in the treatment of manic or mixed symptoms associated with bipolar I disorder.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
  • Study Primary Completion Date: January 2009

Intervention(s) in this Clinical Trial

  • Drug: olanzapine
    • 5-20 mg, oral, once daily (evening), for 6 weeks
  • Drug: haloperidol
    • 2.5-10 mg, oral, twice daily (morning and evening), for 6 weeks.
  • Drug: placebo
    • placebo, oral tablets, twice daily (morning and evening), for 3 weeks

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: Olanzapine
    • olanzapine: 5 to 20 mg per day for 6 weeks
  • Active Comparator: Haloperidol
    • haloperidol: 2.5 to 10 mg per day for 6 weeks
  • Placebo Comparator: Placebo
    • placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks

Outcome Measures for this Clinical Trial

Primary Measures

  • Change From Baseline to 3 Week Endpoint in Young Mania Rating Scale (YMRS) Total Score
    • Time Frame: Baseline, 3 weeks
      Safety Issue?: No

Secondary Measures

  • Change From Baseline to 6 Week Endpoint in Young Mania Rating Scale (YMRS)
    • Time Frame: Baseline, 6 weeks
      Safety Issue?: No
  • Remission Rate of Bipolar Disorder (Olanzapine Versus Haloperidol)
    • Time Frame: 6 weeks
      Safety Issue?: No
  • Change From Baseline to 6 Week Endpoint in Clinical Global Impressions - Bipolar Version (CGI-BP), Overall Severity of Illness
    • Time Frame: Baseline, 6 weeks
      Safety Issue?: No
  • Change From Baseline to 3 Week and 6 Week Endpoints in Clinical Global Impression - Bipolar Version (CGI-BP) Mania Subscale
    • Time Frame: Baseline, 3 weeks, 6 weeks
      Safety Issue?: No
  • Response Rate of Manic Symptoms at 3 Weeks and 6 Weeks
    • Time Frame: Baseline, 3 weeks, 6 weeks
      Safety Issue?: No
  • Remission Rate of Manic Symptoms at 3 Weeks and 6 Weeks
    • Time Frame: 3 weeks, 6 weeks
      Safety Issue?: No
  • Percentage of Participants Who Switched to Symptomatic Depression
    • Time Frame: 3 weeks, 6 weeks
      Safety Issue?: No
  • Change From Baseline to 3 Week and 6 Week Endpoints in the Positive Subscore of Positive and Negative Syndrome Scale (PANSS)
    • Time Frame: Baseline, 3 weeks, 6 weeks
      Safety Issue?: No
  • Percentage of Participants Who Switched to Syndromic Depression
    • Time Frame: 3 weeks, 6 weeks
      Safety Issue?: No
  • Maximum Change From Baseline During 6-Week Period in Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Total Score
    • Time Frame: Baseline to 6 weeks
      Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • Meet the criteria for manic or mixed episodes according to the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) and have a diagnosis of "294.4x Bipolar I Disorder, Most Recent Episode Manic" or "296.6x
  • Bipolar I Disorder, Most Recent Episode Mixed".
  • Have a total score on the Young Mania Rating Scale (YMRS) of at least 20 at Visit 1 and Visit 2.

Exclusion Criteria:

  • Have received an antidepressant or a psychostimulant within 5 days prior to Visit 1.
  • The duration of the current episode is more than 90 days at Visit 1.
  • Have a history or a diagnosis of diabetes mellitus.
  • Have received any psychotropic medication within 2 days prior to Visit 2 (except for benzodiazepines).

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

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 Monday-Friday 9am-5pm Eastern time (UTC/GMT - 5 hours, EST) Study Director Eli Lilly and Company  

Additional Information

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00129220

Study ID Number: 9636

ClinicalTrials.gov Identifier: NCT00129220

Health Authority: Japan: Ministry of Health, Labor and Welfare

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