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

This study has been completed.

First Received on May 6, 2003. Last Updated on January 25, 2011 History of Changes

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00060489

Purpose

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.

Condition	Intervention	Phase
Bipolar Disorder Depression, Bipolar	Drug: SEROQUEL (quetiapine fumarate) Tablets	Phase III

Study Type:	Interventional
Study Design:	Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Bipolar Disorder Depression

Drug Information available for: Quetiapine Quetiapine fumarate

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Study Start Date:	September 2002
Study Completion Date:	September 2003
Primary Completion Date:	September 2003 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00060489

Show 27 Study Locations

Sponsors and Collaborators

AstraZeneca

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00060489 History of Changes
Other Study ID Numbers:	5077US/0049
Study First Received:	May 6, 2003
Last Updated:	January 25, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Bipolar Depression

Additional relevant MeSH terms:

Bipolar Disorder
Depression
Depressive Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Behavioral Symptoms
Quetiapine

Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on February 09, 2012