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

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

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention
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)

Resource links provided by NLM:

MedlinePlus related topics: Bipolar Disorder

Drug Information available for: Quetiapine Quetiapine fumarate Lithium carbonate Lithium citrate

U.S. FDA Resources

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

No publications provided

ClinicalTrials.gov Identifier:	NCT00081380 History of Changes
Other Study ID Numbers:	D1447C00127
Study First Received:	April 9, 2004
Last Updated:	December 19, 2008
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Bipolar I Disorder
Manic Depressive Disorder
Manic Depression, Mixed

Additional relevant MeSH terms:

Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Valproic Acid
Lithium
Quetiapine
Antipsychotic Agents
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses

Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs

ClinicalTrials.gov processed this record on February 12, 2012