Status:
COMPLETED
Controlled Study of the Use of Quetiapine Fumarate in the Treatment of Patients With Bipolar Depression
Lead Sponsor:
AstraZeneca
Conditions:
Bipolar Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine the efficacy of quetiapine compared to placebo in the treatment for a major depressive episode in patients with bipolar disorder after receiving treatment for...
Eligibility Criteria
Inclusion
- Provision of informed consent before enrollment and any study-specific procedures. Patients deemed incapable of providing written consent will not be enrolled in this study; outpatient status
Exclusion
- More than 8 mood episodes in the past year from screen (visit 1);
- A current Axis I disorder other than bipolar disorder within 6 months of screening;
- patients with clinically significant abnormal laboratory findings in the investigator's judgment
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
End Date :
August 1 2005
Estimated Enrollment :
530 Patients enrolled
Trial Details
Trial ID
NCT00083954
Start Date
June 1 2004
End Date
August 1 2005
Last Update
January 4 2013
Active Locations (36)
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1
Research Site
Birmingham, Alabama, United States
2
Research Site
Scottsdale, Arizona, United States
3
Research Site
Cerritos, California, United States
4
Research Site
Garden Grove, California, United States