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: May 6, 2003 Last Updated: June 23, 2005 History of Changes

Sponsored by:	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

MedlinePlus related topics: Bipolar Disorder Depression

Drug Information available for: Quetiapine Quetiapine fumarate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment

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

Study ID Numbers:	5077US/0049
Study First Received:	May 6, 2003
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00060489 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Bipolar Depression

Study placed in the following topic categories:

Depression
Tranquilizing Agents
Bipolar Disorder
Psychotropic Drugs
Central Nervous System Depressants
Depressive Disorder
Antipsychotic Agents

Behavioral Symptoms
Affective Disorders, Psychotic
Quetiapine
Mental Disorders
Mood Disorders
Psychotic Disorders

Additional relevant MeSH terms:

Depression
Tranquilizing Agents
Bipolar Disorder
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Depressive Disorder
Antipsychotic Agents

Pharmacologic Actions
Behavioral Symptoms
Affective Disorders, Psychotic
Quetiapine
Mental Disorders
Therapeutic Uses
Mood Disorders
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 06, 2009