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

Condition(s) targeted: Bipolar Disorder

Intervention: Seroquel®, quetiapine fumarate (atypical antipsychotic) (Drug); lithium (mood stabilizer) (Drug); divalproex (mood stabilizer) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
AstraZeneca Seroquel Medical Science Director, MD, Study Director, Affiliation: AstraZeneca

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.

Official title: Multicenter, Randomized, Parallel-Group, Double-Blind, Phase 3 Comparison of the Efficacy & Safety of Quetiapine Fumarate to Placebo as Adjunct to Mood Stabilizers (Lithium or Divalproex) in the Maintenance Treatment of Bipolar I Disorder in Adult Patients (Abbreviated)

Study design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome: Evaluate the efficacy of quetiapine versus placebo when used as adjunct therapy to mood stabilizer in increasing time to recurrence of a mood event.

Secondary outcome: Evaluate the efficacy of quetiapine versus placebo when used as a adjunct therapy to mod stabilizer in increasing time to recurrence of a manic event.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

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 Criteria:

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

Research Site, Quebec, Canada

Research Site, Birmingham, Alabama, United States

Research Site, Edmonton, Alberta, Canada

Research Site, Scottsdale, Arizona, United States

Research Site, Little Rock, Arkansas, United States

Research Site, Vancouver, British Columbia, Canada

Research Site, Victoria, British Columbia, Canada

Research Site, Anaheim, California, United States

Research Site, Cerritos, California, United States

Research Site, Chula Vista, California, United States

Research Site, Garden Grove, California, United States

Research Site, La Mesa, California, United States

Research Site, Culver City, California, United States

Research Site, Oceanside, California, United States

Research Site, Orange, California, United States

Research Site, Pico Rivera, California, United States

Research Site, Rosemead, California, United States

Research Site, Riverside, 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, Marietta, Georgia, United States

Research Site, Smyrna, Georgia, United States

Research Site, Decatur, Georgia, United States

Research Site, Honolulu, Hawaii, United States

Research Site, Chicago, Illinois, United States

Research Site, Hoffman Estates, Illinois, United States

Research Site, Joliet, Illinois, United States

Research Site, Evansville, Indiana, United States

Research Site, Greenwood, Indiana, United States

Research Site, Indianapolis, Indiana, United States

Research Site, Wichita, Kansas, United States

Research Site, Florence, Kentucky, United States

Research Site, New Orleans, Louisiana, United States

Research Site, Shreveport, Louisiana, United States

Research Site, Lake Charles, Louisiana, United States

Research Site, Winnipeg, Manitoba, Canada

Research Site, Baltimore, Maryland, United States

Research Site, Rockville, Maryland, United States

Research Site, Pittsfield, Massachusetts, United States

Research Site, New Baltimore, Michigan, United States

Research Site, St. Louis, Missouri, United States

Research Site, Clementon, New Jersey, United States

Research Site, Moorestown, New Jersey, United States

Research Site, West Caldwell, New Jersey, United States

Research Site, Albuquerque, New Mexico, United States

Research Site, Bronx, New York, United States

Research Site, Brooklyn, New York, United States

Research Site, New York, New York, United States

Research Site, Butner, North Carolina, United States

Research Site, Raleigh, North Carolina, United States

Research Site, Halifax, Nova Scotia, Canada

Research Site, Beachwood, Ohio, United States

Research Site, Cincinnati, Ohio, United States

Research Site, Dayton, Ohio, United States

Research Site, Medina, Ohio, United States

Research Site, Oklahoma City, Oklahoma, United States

Research Site, Tulsa, Oklahoma, United States

Research Site, Hamilton, Ontario, Canada

Research Site, Kingston, Ontario, Canada

Research Site, Markham, Ontario, Canada

Research Site, Mississauga, Ontario, Canada

Research Site, Oshawa, Ontario, Canada

Research Site, Toronto, Ontario, Canada

Research Site, Eugene, Oregon, United States

Research Site, Portland, Oregon, United States

Research Site, Emmaus, Pennsylvania, United States

Research Site, Moon Township, Pennsylvania, United States

Research Site, Philadelphia, Pennsylvania, United States

Research Site, Montreal, Quebec, Canada

Research Site, Charleston, South Carolina, United States

Research Site, Memphis, Tennessee, United States

Research Site, Austin, Texas, United States

Research Site, Dallas, Texas, United States

Research Site, DeSoto, Texas, United States

Research Site, Houston, Texas, United States

Research Site, Irving, Texas, United States

Research Site, San Antonio, Texas, United States

Research Site, Wichita Falls, Texas, United States

Research Site, Charlottesville, Virginia, United States

Research Site, Falls Church, Virginia, United States

Research Site, Virginia Beach, Virginia, United States

Research Site, Richmond, Virginia, United States

Research Site, Bellevue, Washington, United States

Research Site, Kirkland, Washington, United States

Research Site, Morgantown, West Virginia, United States

Starting date: March 2004
Ending date: September 2006
Last updated: December 13, 2007