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

Completed · Phase 3

Conditions studied: Bipolar I 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

NCT00107731

Run by

AstraZeneca

People needed

710

Starts

2004-04-01

Expected to finish

2006-10-01

Last updated by the study team

2009-03-25

Who can join

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

You may qualify if…

• 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…

• 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 — Beverly Hills, California, United States
• Research Site — Chula Vista, California, United States
• Research Site — Redlands, California, United States
• Research Site — San Francisco, California, United States
• Research Site — Santa Ana, California, United States
• Research Site — Gainesville, Florida, United States
• Research Site — Jacksonville, Florida, United States
• Research Site — Miami, Florida, United States
• Research Site — Sarasota, Florida, United States
• Research Site — Tampa, Florida, United States
• Research Site — Winter Park, Florida, United States
• Research Site — Granite City, Illinois, United States
• Research Site — Libertyville, Illinois, United States
• Research Site — Schaumburg, Illinois, United States
• Research Site — Wichita, Kansas, United States
• Research Site — Metairie, Louisiana, United States
• Research Site — Glen Burnie, Maryland, United States
• Research Site — Kalamazoo, Michigan, United States
• Research Site — Saint Charles, Missouri, United States
• Research Site — St Louis, Missouri, United States
• Research Site — Brooklyn, New York, United States
• Research Site — Olean, New York, United States
• Research Site — Rochester, New York, United States
• Research Site — Morganton, North Carolina, United States
• Research Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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