Status:
COMPLETED
Efficacy and Safety of Seroquel Plus Mood Stabilizer in the Maintenance of Bipolar I Disorder
Lead Sponsor:
AstraZeneca
Conditions:
Bipolar 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
- Open-Label
- 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
- Open-Label
- 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 :
March 1 2004
Trial Type :
INTERVENTIONAL
End Date :
September 1 2006
Estimated Enrollment :
710 Patients enrolled
Trial Details
Trial ID
NCT00081380
Start Date
March 1 2004
End Date
September 1 2006
Last Update
December 22 2008
Active Locations (94)
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1
Research Site
Birmingham, Alabama, United States
2
Research Site
Scottsdale, Arizona, United States
3
Research Site
Little Rock, Arkansas, United States
4
Research Site
Anaheim, California, United States