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

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ClinicalTrials.gov Identifier: NCT00060489
Recruitment Status : Completed
First Posted : May 8, 2003
Last Update Posted : January 26, 2011
Sponsor:
Information provided by:
AstraZeneca

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

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
U.S. FDA Resources





Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

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 ClinicalTrials.gov identifier (NCT number): NCT00060489


  Show 27 Study Locations
Sponsors and Collaborators
AstraZeneca

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov 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:
Depression
Depressive Disorder
Bipolar Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Bipolar and Related Disorders
Quetiapine Fumarate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs