Efficacy & Safety of Seroquel Plus Mood Stabilizer in the Maintenance of Bipolar I Disorder - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00107731

Purpose

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.

Condition	Intervention	Phase
Bipolar I Disorder	Drug: quetiapine fumarate Drug: lithium Drug: divalproex	Phase III

Drug Information available for: Divalproex sodium Valproate Sodium Valproic acid Quetiapine Quetiapine fumarate Lithium carbonate Lithium citrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	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)

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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 Measures:

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

Estimated Enrollment:	710
Study Start Date:	April 2004

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00107731

Show 170 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

AstraZeneca Seroquel Medical Science Director, MD

AstraZeneca

More Information

Study ID Numbers:	D1447C00126
Study First Received:	April 7, 2005
Last Updated:	December 19, 2008
ClinicalTrials.gov Identifier:	NCT00107731
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Bipolar I Disorder
Manic Depressive Disorder
Manic Depression

Study placed in the following topic categories:

Quetiapine
Depression
Bipolar Disorder
Lithium Carbonate

Depressive Disorder
Valproic Acid
Lithium

Additional relevant MeSH terms:

Tranquilizing Agents
Pathologic Processes
Disease
Therapeutic Uses
Physiological Effects of Drugs
Psychotropic Drugs

Central Nervous System Depressants
Antimanic Agents
Antipsychotic Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009