Status:
COMPLETED
Efficacy and Safety of Olanzapine in the Extended Treatment for Manic or Mixed Episode of Bipolar I Disorder
Lead Sponsor:
Eli Lilly and Company
Conditions:
Manic or Mixed Episode Associated With Bipolar I Disorder
Eligibility:
All Genders
20-65 years
Phase:
PHASE3
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
139 Patients enrolled
Trial Details
Trial ID
NCT00266630
Start Date
November 1 2005
End Date
May 1 2009
Last Update
December 28 2010
Active Locations (11)
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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.
Akita, Japan, 010-1654
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, 292-0061
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.
Fukuoka, Japan, 812-8582
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.
Gunma, Japan, 371-8511