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

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: May 6, 2003
Last updated: January 25, 2011
Last verified: January 2011
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 3

Study Type: Interventional
Study Design: Primary Purpose: Treatment

Resource links provided by NLM:

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)

Ages Eligible for Study:   18 Years to 65 Years   (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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00060489

  Show 27 Study Locations
Sponsors and Collaborators
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00060489     History of Changes
Other Study ID Numbers: 5077US/0049
Study First Received: May 6, 2003
Last Updated: January 25, 2011

Keywords provided by AstraZeneca:
Bipolar Depression

Additional relevant MeSH terms:
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 processed this record on June 23, 2017