Status:
COMPLETED
Quetiapine Fumarate Bipolar Maintenance Monotherapy
Lead Sponsor:
AstraZeneca
Conditions:
Bipolar Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is a multicenter, randomized, parallel-group, double-blind, placebo-controlled study to evaluate the efficacy and safety of quetiapine and lithium (comparator in the study) for up to 104 weeks of...
Eligibility Criteria
Inclusion
- Signed informed consent
- 18 years or older
- A diagnosis of Bipolar I Disorder
- Have a current manic, depressed or mixed episode
- Have had a manic, depressed or mixed episode during the last 26 weeks that was treated with quetiapine
- Female patients of childbearing potential must be using a reliable method of contraception
Exclusion
- Pregnancy
- Substance or alcohol dependence at enrollment
- Unstable thyroid function
- Unstable Diabetes
- Unstable or inadequately treated medical illness e.g., angina pectoris and hypertension
- Use of an experimental drug within 30 days of enrollment
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
1255 Patients enrolled
Trial Details
Trial ID
NCT00314184
Start Date
March 1 2005
End Date
July 1 2007
Last Update
December 22 2008
Active Locations (95)
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1
Research Site
Cerritos, California, United States
2
Research Site
San Diego, California, United States
3
Research Site
Santa Ana, California, United States
4
Research Site
Washington D.C., District of Columbia, United States