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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00060489
Recruitment Status : Completed
First Posted : May 8, 2003
Last Update Posted : January 26, 2011
Information provided by:

Brief Summary:
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 or disease Intervention/treatment Phase
Bipolar Disorder Depression, Bipolar Drug: SEROQUEL (quetiapine fumarate) Tablets Phase 3

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Study Start Date : September 2002
Actual Primary Completion Date : September 2003
Actual Study Completion Date : September 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00060489

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Sponsors and Collaborators

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00060489     History of Changes
Other Study ID Numbers: 5077US/0049
First Posted: May 8, 2003    Key Record Dates
Last Update Posted: January 26, 2011
Last Verified: January 2011

Keywords provided by AstraZeneca:
Bipolar Depression

Additional relevant MeSH terms:
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Depressive Disorder
Bipolar Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Bipolar and Related Disorders
Quetiapine Fumarate
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs