Status:
COMPLETED
Efficacy & Safety of Seroquel Plus Mood Stabilizer in the Maintenance of Bipolar I Disorder
Lead Sponsor:
AstraZeneca
Conditions:
Bipolar I Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine whether quetiapine when used as adjunct to lithium or divalproex is safe and effective in the maintenance treatment of adult patients with Bipolar I Disorder....
Eligibility Criteria
Inclusion
- A diagnosis of Bipolar I Disorder, Most recent episode Manic (296.4x), or Bipolar I Disorder, Most Recent Episode Depressed (296.5x), or Bipolar I Disorder, Most recent Episode Mixed (296.6x), with or without psychotic features, as defined by Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM-IV)
- At least 1 manic, depressed, or mixed episode in the 2 years prior to the index episode.
- Able to understand and comply with the requirements of the study.
Exclusion
- Diagnosis of an anxiety disorder as defined by DSM-IV, which was treated with medication within the past year.
- Known intolerance or lack of response to quetiapine fumarate or to the assigned mood stabilizer, as judged by the investigator.
- Previously randomized into this study or D1447C00126
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
End Date :
October 1 2006
Estimated Enrollment :
710 Patients enrolled
Trial Details
Trial ID
NCT00107731
Start Date
April 1 2004
End Date
October 1 2006
Last Update
March 25 2009
Active Locations (166)
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1
Research Site
Birmingham, Alabama, United States
2
Research Site
Beverly Hills, California, United States
3
Research Site
Chula Vista, California, United States
4
Research Site
Redlands, California, United States