Efficacy and Safety of Olanzapine in the Extended Treatment for Manic or Mixed Episode of Bipolar I Disorder

Official Title: “Efficacy and Safety of Olanzapine in the Extended Treatment for Manic or Mixed Episode of Bipolar I Disorder”

The efficacy and safety of the extended treatment to patients with most recent episode manic or mixed who completed previous double blind study (F1D-JE-BMAC [Study BMAC]) will be examined.

Intervention(s) in this Clinical Trial

• Drug: olanzapine
  • oral, daily
• Drug: lithium
  • Dose adjusted according to local package insert
• Drug: valproate
  • Dose adjusted according to local package insert
• Drug: carbamazepine
  • Dose adjusted according to local package insert

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Olanzapine Monotherapy
  • Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanzapine 5-20 mg for 18 weeks.
• Experimental: Olanzapine + Mood Stabilizer
  • Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.

Primary Measures

• Change From Baseline to Endpoint in Young Mania Rating Scale (YMRS) Total Scores - Olanzapine Monotherapy Arm Only
  • Time Frame: baseline through 18 weeks
    Safety Issue?: No
• Number of Participants With Response of Manic Symptoms - Olanzapine Monotherapy Arm Only
  • Time Frame: baseline through 18 weeks
    Safety Issue?: No
• Number of Participants With Remission of Mania - Olanzapine Monotherapy Arm Only
  • Time Frame: baseline through 18 weeks
    Safety Issue?: No
• Number of Participants With Relapse of Manic Symptoms - Olanzapine Monotherapy Arm Only
  • Time Frame: baseline through 18 weeks
    Safety Issue?: No

Secondary Measures

• Change From Baseline to Endpoint on the YMRS Total Score - Olanzapine + Mood Stabilizer Only
  • Time Frame: baseline through 18 weeks
    Safety Issue?: No
• Clinical Global Impressions - Bipolar Version, Severity of Illness (CGI-BP) Overall, Visit Data
  • Time Frame: baseline, Weeks 1, 2, 4, 6, 10, 14, 18
    Safety Issue?: No
• Number of Participants Who Experienced Switch to Symptomatic Depression as Measured by the Hamilton Depression Scale - 17 Item Version (HAMD-17)
  • Time Frame: baseline through 18 weeks
    Safety Issue?: No
• Number of Participants With Relapse of Depressive Symptoms
  • Time Frame: baseline through 18 weeks
    Safety Issue?: No
• Number of Participants Who Experienced Remission of Bipolar Disorder
  • Time Frame: Week 18
    Safety Issue?: No
• Positive and Negative Syndrome Scale Positive Scores - Visit Data
  • Time Frame: baseline, Weeks 1, 2, 4, 6, 10, 14, 18
    Safety Issue?: No
• Number of Participants Who Switched to Syndromic Depression
  • Time Frame: baseline through 18 weeks
    Safety Issue?: No
• Maximum Change From Baseline to Endpoint on the Drug Induced Extra-Pyramidal Symptoms Scale (DIEPSS) - Total Score
  • Time Frame: baseline through 18 weeks
    Safety Issue?: Yes
• Number of Participants With Treatment-Emergent Parkinsonism Based on DIEPSS Scores
  • Time Frame: baseline through 18 weeks
    Safety Issue?: Yes
• Number of Participants With Treatment-Emergent Akathisia Based on DIEPSS Scores
  • Time Frame: baseline through 18 weeks
    Safety Issue?: Yes
• Number of Participants With Treatment-Emergent Dystonia Based on DIEPSS Scores
  • Time Frame: baseline through 18 weeks
    Safety Issue?: Yes
• Number of Participants With Treatment-Emergent Dyskenisia Based on DIEPSS Scores
  • Time Frame: baseline through 18 weeks
    Safety Issue?: Yes
• Number of Participants With Potentially Clinically Significant Changes in Laboratory Analytes
  • Time Frame: baseline through 18 weeks
    Safety Issue?: Yes
• Number of Participants With Potentially Clinically Significant Changes in Vital Signs and Weight
  • Time Frame: baseline through 18 weeks
    Safety Issue?: Yes
• Number of Participants With Potentially Clinically Significant Changes in Electrocardiograms - High Fridericia Corrected QT Interval (QTcF)
  • Time Frame: baseline through 18 weeks
    Safety Issue?: Yes
• Number of Participants With Treatment-emergent Abnormal, High, or Low Laboratory Values
  • Time Frame: baseline through 18 weeks
    Safety Issue?: Yes

Inclusion Criteria:

• Enrolled in and completed Study BMAC (NCT00129220), or those who discontinued Study
• BMAC at Visit 4 or Visit 5 due to lack of efficacy and for whom the Young Mania
• Rating Scale (YMRS) total score at the time of discontinuation was not lower than that at baseline of Study BMAC
• Are diagnosed as "294.4x Bipolar I Disorder, Most Recent Episode Manic" or "296.6x
• Bipolar I Disorder, Most Recent Episode Mixed," as determined by the Mini-International Neuropsychiatric Interview (MINI)

Exclusion Criteria:

• Have a diagnosis of diabetes mellitus
• Significant protocol deviation in Study BMAC
• The actual date of the final visit of Study BMAC is 4 days or more later than the scheduled date of first visit in Study BMEX

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 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 08, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00266630

Study ID Number: 9637

ClinicalTrials.gov Identifier: NCT00266630

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