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
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00060489

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Sponsors and Collaborators
  More Information

No publications provided 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
Depressive Disorder
Affective Disorders, Psychotic
Behavioral Symptoms
Mental Disorders
Mood Disorders
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents processed this record on October 09, 2015