Status:
COMPLETED
Safety and Efficacy of Olanzapine in the Long-term Treatment for Bipolar I Disorder, Depressed
Lead Sponsor:
Eli Lilly and Company
Conditions:
Bipolar I Disorder
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
To assess the efficacy and safety of olanzapine in the long-term treatment for patients with bipolar I disorder, depressed.
Detailed Description
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 episo...
Eligibility Criteria
Inclusion
- Patients must be aged 18 to less than 75 years.
- 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.
- All female patients must test negative for pregnancy.
- 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.
- 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.
- Patients must fulfill the diagnostic criteria for bipolar I disorder, most recent episode depressed, as defined in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR).
- 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.
- Patients must have a current Young Mania Rating Scale (YMRS) Total score =\<8.
Exclusion
- Is investigator site personnel directly affiliated with this study or their immediate families.
- Is a Lilly employee.
- Has previously completed or withdrawn from this study or any other study investigating olanzapine.
- Is pregnant or nursing.
- 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.
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT00618748
Start Date
February 1 2008
End Date
September 1 2010
Last Update
July 27 2011
Active Locations (10)
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1
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Aichi, Japan, 470-1168
2
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Chiba, Japan, 270-1694
3
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Hiroshima, Japan, 731-0501
4
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Kanagawa, Japan, 231-0027