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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00107731
First received: April 7, 2005
Last updated: March 24, 2009
Last verified: March 2009
History of Changes

April 7, 2005
March 24, 2009
April 2004
 
Evaluate the efficacy of quetiapine versus placebo when used as adjunct therapy to mood stabilizer in increasing time to recurrence of a mood event.
Same as current
Complete list of historical versions of study NCT00107731 on ClinicalTrials.gov Archive Site
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
Same as current
 
 
 
Efficacy & Safety of Seroquel Plus Mood Stabilizer in the Maintenance of Bipolar I Disorder
A Multicenter, Randomized, Parallel-Group, Double-Blind, Phase 3 Comparison of the Efficacy & Safety of Quetiapine Fumarate to Placebo When Used as Adjunct to Mood Stabilizers (Lithium or Valproate) in the Maintenance Treatment of Bipolar I Disorder in Adult Patients (Abbreviated)

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.
 
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Bipolar I Disorder
  • Drug: quetiapine fumarate
  • Drug: lithium
  • Drug: divalproex
 
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
710
October 2006
 

Inclusion Criteria:

  • 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:

  • 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Belgium,   Bulgaria,   Czech Republic,   Finland,   France,   Germany,   Hungary,   Italy,   Norway,   Poland,   Russian Federation,   South Africa,   Spain,   Sweden,   Turkey,   United Kingdom
 
NCT00107731
D1447C00126
 
 
AstraZeneca
 
Study Director: AstraZeneca Seroquel Medical Science Director, MD AstraZeneca
AstraZeneca
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP