Status:
COMPLETED
Bipolar Depression Study: Bipolar Depression Assessment Study on Treatment Response
Lead Sponsor:
Eli Lilly and Company
Conditions:
Depression, Bipolar
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The primary objective of this study is to assess the efficacy of olanzapine and fluoxetine combined on all the visits as compared with the baseline visit in patients with bipolar disorder, measured by...
Eligibility Criteria
Inclusion
- Meet criteria for bipolar depression, in the opinion of the investigator, according to the Diagnostic and Statistical Manual of Mental Disorders \[Text Revision\] (DSM-IV-TR) disease diagnostic criteria.
- Patients must have experienced, in the opinion of the investigator, at least one previous hypomanic, manic or mixed episode as defined in DSM-IV-TR.
- Subjects must have an initial score at Visit 1 of at least 20 on the MADRS.
Exclusion
- Any patient currently meeting DSM-IV-TR criteria rapid-cycling course.
- A CGI-Severity - Mania score of at least 3.
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
End Date :
March 1 2006
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00191399
Start Date
May 1 2004
End Date
March 1 2006
Last Update
January 26 2007
Active Locations (10)
Enter a location and click search to find clinical trials sorted by distance.
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.
Seattle, Washington, United States
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 9AM to 5PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician
Bayamón, Puerto Rico, 00956
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 9AM to 5PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician
Caguas, Puerto Rico, 725
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 9AM to 5PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician
Canovanas, Puerto Rico