Status:
COMPLETED
Trial of Olanzapine in Patients With Manic or Mixed Episode of Bipolar I Disorder
Lead Sponsor:
Eli Lilly and Company
Conditions:
Bipolar Disorder
Eligibility:
All Genders
20-65 years
Phase:
PHASE3
Brief Summary
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.
Eligibility Criteria
Inclusion
- Meet the criteria for manic or mixed episodes according to the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (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 Young Mania Rating Scale (YMRS) of at least 20 at Visit 1 and Visit 2.
Exclusion
- 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).
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
224 Patients enrolled
Trial Details
Trial ID
NCT00129220
Start Date
July 1 2005
End Date
January 1 2009
Last Update
December 28 2010
Active Locations (16)
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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.
Akita, Japan, 010-1654
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.
Chiba, Japan, 283-0062
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.
Fukuoka, Japan, 807-8555