Efficacy and Safety of Seroquel Plus Mood Stabilizer in the Maintenance of Bipolar I Disorder

Completed · Phase 3

Conditions studied: Bipolar Disorder

In brief

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. The study consists of enrollment and 2 phases, the Open-label treatment Phase and the Randomized treatment Phase. PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

Key facts

Study ID

NCT00081380

Run by

AstraZeneca

People needed

710

Starts

2004-03-01

Expected to finish

2006-09-01

Last updated by the study team

2008-12-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Research Site — Scottsdale, Arizona, United States
• Research Site — Little Rock, Arkansas, United States
• Research Site — Anaheim, California, United States
• Research Site — Cerritos, California, United States
• Research Site — Chula Vista, California, United States
• Research Site — Culver City, California, United States
• Research Site — Garden Grove, California, United States
• Research Site — La Mesa, California, United States
• Research Site — Oceanside, California, United States
• Research Site — Orange, California, United States
• Research Site — Pico Rivera, California, United States
• Research Site — Riverside, California, United States
• Research Site — Rosemead, California, United States
• Research Site — San Diego, California, United States
• Research Site — San Francisco, California, United States
• Research Site — Santa Ana, California, United States
• Research Site — Farmington, Connecticut, United States
• Research Site — New Britain, Connecticut, United States
• Research Site — Jacksonville, Florida, United States
• Research Site — Miami, Florida, United States
• Research Site — Orlando, Florida, United States
• Research Site — West Palm Beach, Florida, United States
• Research Site — Winter Park, Florida, United States
• Research Site — Atlanta, Georgia, United States
• Research Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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