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COMPLETEDPHASE3

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

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)

NCT00081380•AstraZeneca

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (94)

Research Site

Birmingham, Alabama, United States

Research Site

Scottsdale, Arizona, United States

Research Site

Little Rock, Arkansas, United States

Research Site

Anaheim, California, United States

Research Site

Cerritos, California, United States

Research Site

Chula Vista, California, United States

Research Site

Culver City, California, United States

Research Site

Garden Grove, California, United States

Research Site

La Mesa, California, United States

Research Site

Oceanside, California, United States

Key Dates

Start Date

March 1, 2004

Completion Date

September 1, 2006

Last Updated

December 22, 2008

Enrollment

710

Estimated participants

Conditions

Bipolar Disorder

Interventions

Seroquel®, quetiapine fumarate (atypical antipsychotic)

DRUG

lithium (mood stabilizer)

DRUG

divalproex (mood stabilizer)

DRUG

University of Iowa Interventional Psychiatry Service Patient Registry

NCT04480918

Treatment Resistant DepressionMajor Depressive Episode+5 more

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RECRUITINGPHASE3

A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine

NCT07140913

ManiaBipolar Disorder

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 22, 2008Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

University of Iowa Interventional Psychiatry Service Patient Registry

A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine

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