Completed

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)

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What is being tested

Data Collection

Who is being recruted

Bipolar and Related Disorders+1

+ Mental Disorders

+ Bipolar Disorder

Over 18 Years
See all eligibility criteria
How is the trial designed

Prevention Study

Phase 3
Interventional
Study Start: March 2004
See protocol details

Summary

Principal SponsorAstraZeneca
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2004

Actual date on which the first participant was enrolled.

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.

Official TitleMulticenter, 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
Principal SponsorAstraZeneca
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

710 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bipolar and Related DisordersMental DisordersBipolar DisorderMood Disorders

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 94 locations

Suspended

Research Site

Birmingham, United StatesSee the location
Suspended

Research Site

Scottsdale, United States
Suspended

Research Site

Little Rock, United States
Suspended

Research Site

Anaheim, United States
Completed94 Study Centers