Completed

A Confirmatory Multicenter, Double-blind, Randomized, Placebo Controlled Study of the Use of Quetiapine Fumarate (SEROQUEL) in the Treatment of Patients With Bipolar Depression

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What is being tested

Data Collection

Who is being recruted

Bipolar and Related Disorders+1

+ Mental Disorders

+ Bipolar Disorder

From 18 to 65 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: June 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: June 1, 2004

Actual date on which the first participant was enrolled.

The purpose of this study is to determine the efficacy of quetiapine compared to placebo in the treatment for a major depressive episode in patients with bipolar disorder after receiving treatment for up to 8 weeks.

Official TitleA Confirmatory Multicenter, Double-blind, Randomized, Placebo Controlled Study of the Use of Quetiapine Fumarate (SEROQUEL) in the Treatment of Patients With Bipolar Depression 
NCT00083954
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

530 patients to be enrolled

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

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

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.

From 18 to 65 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: * Provision of informed consent before enrollment and any study-specific procedures. Patients deemed incapable of providing written consent will not be enrolled in this study; outpatient status Exclusion Criteria: * More than 8 mood episodes in the past year from screen (visit 1); * A current Axis I disorder other than bipolar disorder within 6 months of screening; * patients with clinically significant abnormal laboratory findings in the investigator's judgment

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 36 locations

Suspended

Research Site

Birmingham, United StatesSee the location
Suspended

Research Site

Scottsdale, United States
Suspended

Research Site

Cerritos, United States
Suspended

Research Site

Garden Grove, United States
Completed36 Study Centers