Safety and Efficacy Trial of the Use of Quetiapine Fumarate (SEROQUEL®) in the Treatment of Patients With Bipolar Depression

The purpose of this study is to evaluate the efficacy and safety of quetiapine in the treatment of a major depressive episode in patients with bipolar disorder.

Completed

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Key information

Conditions

Bipolar Disorder Bipolar and Related Disorders Depression, Bipolar Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Birmingham, Alabama, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Written Informed Consent;
Bipolar disorder with most recent episode depressed;
Outpatient status

Exclusion criteria

Patients with a current Axis I disorder other than bipolar disorder within 6 months of screening;
Patients whose current episode of depression exceeds 12 months or is less than 4 weeks

Treatment and study plan

SEROQUEL (quetiapine fumarate) Tablets

Drug

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Important dates

Study start: 2002
Primary completion: 2003
Study completion: 2003
First posted: May 8, 2003
Registry last updated: Jan 26, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed