Official Title: “Safety and Efficacy of Olanzapine (LY170053) in the Long-Term Treatment for Patients With Bipolar I Disorder, Depressed”

To assess the efficacy and safety of olanzapine in the long-term treatment for patients with bipolar I disorder, depressed.

Study Type: Interventional

Study Design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: March 2011

This is an open-label, multi-center, long-term treatment study conducted only in Japanese sites. The subjects are patients who fulfill the diagnostic criteria for bipolar I disorder, most recent episode depressed, as defined in the DSM-IV-TR (296.50=unspecified, 296.52=moderate severity, 296.53=severe without psychotic features, 296.54=severe with psychotic features), who have completed Study HGMP and patients who did not participate in Study HGMP who have been recruited to participate in Study HGMS.

Intervention(s) in this Clinical Trial

• Drug: Olanzapine
  • 5-20mg/day,oral,daily,48weeks

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A

Primary Measures

• To assess the safety of olanzapine alone or in combination with allowed concomitant medications in the long-term treatment of patients who fulfill the diagnostic criteria for bipolar I disorder.
  • Time Frame: 48 weeks
    Safety Issue?: Yes

Secondary Measures

• To assess the overall safety and efficacy in the long-term treatment of olanzapine orally, once daily within the range of 5 - 20 mg.
  • Time Frame: 48 weeks
    Safety Issue?: Yes

Inclusion Criteria:

• 1. Patients must be aged 18 to less than 75 years.
• 2. Each patient must be reliable, have a level of understanding sufficient to perform all tests and examinations required by the protocol, and must understand the nature of the study and have provided informed consent.
• 3. All female patients must test negative for pregnancy
• 4. Females of breast-feeding potential must agree not to breastfeed an infant during the study and for 1 month following the last dose of study drug
• 5. Male patients who are not surgically sterilized must agree to use a reliable method of birth control during the study and for 1 month following the last dose of study drug
• 6. Patients must fulfill the diagnostic criteria for bipolar I disorder, most recent episode depressed, as defined in the DSM-IV-TR
• 7. Patients must have experienced, in the opinion of the investigator, at least one previous manic or mixed episode, as defined in the DSM-IV-TR.
• 8. Patients must have a current YMRS Total score =<8

Exclusion Criteria:

• 1. Is investigator site personnel directly affiliated with this study or their immediate families
• 2. Is a Lilly employee
• 3. Has previously completed or withdrawn from this study or any other study investigating olanzapine.
• 4. Is pregnant or nursing.
• 5. Has a serious, unstable illness such that death is anticipated within 1 year or intensive care unit hospitalization for the disease is anticipated within 6 months.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 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 (1-877-285-4599) or 1-317-615-4559 Mon-Fri 9 AM-5 PM Eastern time (UTC/GMT - 5 hours, EST) Study Director Eli Lilly and Company  

Overall Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 

Information obtained from ClinicalTrials.gov on August 28, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00618748

Study ID Number: 11682

ClinicalTrials.gov Identifier: NCT00618748

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

Lilly Clinical Trial Registry