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

Study Primary Completion Date: February 2009

Intervention(s) in this Clinical Trial

• Drug: olanzapine
  • 5-20mg, oral, once daily (evening), for 6 weeks
• Drug: haloperidol
  • 2.5-10mg, 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: A
  • olanzapine
• Active Comparator: B
  • haloperidol
• Placebo Comparator: C
  • placebo

Primary Measures

• To confirm the superiority of olanzapine versus placebo in improving the severity of the manic symptoms, as measured by the Young Mania Rating Scale, associated with bipolar I disorder.
  • Time Frame: 3 weeks
    Safety Issue?: No

Secondary Measures

• Compare olanzapine to haloperidol in improving overall bipolar symptomatology as measured by the Young Mania Rating Scale, Hamilton Depression Scale - 17 item version and Clinical Global Impressions - Bipolar Version, Severity of Illness.
  • Time Frame: 6 weeks
    Safety Issue?: No
• To evaluate the efficacy of olanzapine on overall manic symptomatology (both depression and mania) in comparison to placebo and haloperidol as measured by changes in the Clinical Global Impression - Bipolar Version, Severity of Illness.
  • Time Frame: 6 weeks
    Safety Issue?: No
• To evaluate the efficacy of olanzapine on manic symptoms in comparison to placebo and haloperidol as measured by remission of mania according to the Young Mania Rating Scale.
  • Time Frame: 6 weeks
    Safety Issue?: No
• To evaluate the efficacy of olanzapine on depressive symptoms in comparison to placebo and haloperidol as measured by the Hamilton Depression Scale - 17 item version.
  • Time Frame: 6 weeks
    Safety Issue?: No
• To evaluate the efficacy of olanzapine on psychotic symptoms in comparison to placebo and haloperidol as measured by changes in the Positive Subscore of Positive and Negative Syndrome Scale.
  • Time Frame: 6 weeks
    Safety Issue?: No
• To evaluate switch-to-depression between therapies; defined as a shift from a Manic Episode at baseline to a Major Depressive Episode after randomization, based on Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Text Revision.
  • Time Frame: 6 weeks
    Safety Issue?: No

Inclusion Criteria:

• Meet the criteria for manic or mixed episodes according to the 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 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

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 Monday-Friday 9am-5pm 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/NCT00129220

Study ID Number: 9636

ClinicalTrials.gov Identifier: NCT00129220

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

Lilly Clinical Trial Registry