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

Bipolar Disorder Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00081380
• Other study ID #: D1447C00127
• Status: Completed
• Phase: Phase 3
• First received: April 9, 2004
• Last updated: December 19, 2008
• Start date: March 2004
• Est. completion date: September 2006

Study information

• Verified date: December 2008
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 710
• Est. completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bipolar Disorder
• Disease

Intervention

Drug:
• Seroquel®, quetiapine fumarate (atypical antipsychotic)

• lithium (mood stabilizer)

• divalproex (mood stabilizer)

Locations

Country	Name	City	State
Canada	Research Site	Edmonton	Alberta
Canada	Research Site	Halifax	Nova Scotia
Canada	Research Site	Hamilton	Ontario
Canada	Research Site	Kingston	Ontario
Canada	Research Site	Markham	Ontario
Canada	Research Site	Mississauga	Ontario
Canada	Research Site	Montreal	Quebec
Canada	Research Site	Oshawa	Ontario
Canada	Research Site	Quebec
Canada	Research Site	Toronto	Ontario
Canada	Research Site	Vancouver	British Columbia
Canada	Research Site	Victoria	British Columbia
Canada	Research Site	Winnipeg	Manitoba
United States	Research Site	Albuquerque	New Mexico
United States	Research Site	Anaheim	California
United States	Research Site	Atlanta	Georgia
United States	Research Site	Austin	Texas
United States	Research Site	Baltimore	Maryland
United States	Research Site	Beachwood	Ohio
United States	Research Site	Bellevue	Washington
United States	Research Site	Birmingham	Alabama
United States	Research Site	Bronx	New York
United States	Research Site	Brooklyn	New York
United States	Research Site	Butner	North Carolina
United States	Research Site	Cerritos	California
United States	Research Site	Charleston	South Carolina
United States	Research Site	Charlottesville	Virginia
United States	Research Site	Chicago	Illinois
United States	Research Site	Chula Vista	California
United States	Research Site	Cincinnati	Ohio
United States	Research Site	Clementon	New Jersey
United States	Research Site	Culver City	California
United States	Research Site	Dallas	Texas
United States	Research Site	Dayton	Ohio
United States	Research Site	Decatur	Georgia
United States	Research Site	DeSoto	Texas
United States	Research Site	Emmaus	Pennsylvania
United States	Research Site	Eugene	Oregon
United States	Research Site	Evansville	Indiana
United States	Research Site	Falls Church	Virginia
United States	Research Site	Farmington	Connecticut
United States	Research Site	Florence	Kentucky
United States	Research Site	Garden Grove	California
United States	Research Site	Greenwood	Indiana
United States	Research Site	Hoffman Estates	Illinois
United States	Research Site	Honolulu	Hawaii
United States	Research Site	Houston	Texas
United States	Research Site	Indianapolis	Indiana
United States	Research Site	Irving	Texas
United States	Research Site	Jacksonville	Florida
United States	Research Site	Joliet	Illinois
United States	Research Site	Kirkland	Washington
United States	Research Site	La Mesa	California
United States	Research Site	Lake Charles	Louisiana
United States	Research Site	Little Rock	Arkansas
United States	Research Site	Marietta	Georgia
United States	Research Site	Medina	Ohio
United States	Research Site	Memphis	Tennessee
United States	Research Site	Miami	Florida
United States	Research Site	Moon Township	Pennsylvania
United States	Research Site	Moorestown	New Jersey
United States	Research Site	Morgantown	West Virginia
United States	Research Site	New Baltimore	Michigan
United States	Research Site	New Britain	Connecticut
United States	Research Site	New Orleans	Louisiana
United States	Research Site	New York	New York
United States	Research Site	Oceanside	California
United States	Research Site	Oklahoma City	Oklahoma
United States	Research Site	Orange	California
United States	Research Site	Orlando	Florida
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Pico Rivera	California
United States	Research Site	Pittsfield	Massachusetts
United States	Research Site	Portland	Oregon
United States	Research Site	Raleigh	North Carolina
United States	Research Site	Richmond	Virginia
United States	Research Site	Riverside	California
United States	Research Site	Rockville	Maryland
United States	Research Site	Rosemead	California
United States	Research Site	San Antonio	Texas
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	Scottsdale	Arizona
United States	Research Site	Shreveport	Louisiana
United States	Research Site	Smyrna	Georgia
United States	Research Site	St. Louis	Missouri
United States	Research Site	Tulsa	Oklahoma
United States	Research Site	Virginia Beach	Virginia
United States	Research Site	West Caldwell	New Jersey
United States	Research Site	West Palm Beach	Florida
United States	Research Site	Wichita	Kansas
United States	Research Site	Wichita Falls	Texas
United States	Research Site	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.