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

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.

Condition	Intervention	Phase
Bipolar Disorder	Drug: Seroquel®, quetiapine fumarate (atypical antipsychotic) Drug: lithium (mood stabilizer) Drug: divalproex (mood stabilizer)	Phase III

MedlinePlus related topics:

Bipolar Disorder

Drug Information available for:

Quetiapine Quetiapine fumarate Lithium carbonate Lithium citrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

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)

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:	March 2004
Study Completion Date:	September 2006

Eligibility

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00081380

Show 94 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators


Study Director:	AstraZeneca Seroquel Medical Science Director, MD	AstraZeneca

More Information

Study ID Numbers:	D1447C00127
First Received:	April 9, 2004
Last Updated:	December 13, 2007
ClinicalTrials.gov Identifier:	NCT00081380
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Bipolar I Disorder

Manic Depressive Disorder

Manic Depression, Mixed

Study placed in the following topic categories:

Quetiapine

Affective Disorders, Psychotic

Depression

Mental Disorders

Bipolar Disorder

Mood Disorders

Lithium Carbonate

Psychotic Disorders

Depressive Disorder

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 November 30, 2008

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00081380