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

Bipolar Disorder Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00060489
• Other study ID #: 5077US/0049
• Status: Completed
• Phase: Phase 3
• First received: May 6, 2003
• Last updated: January 25, 2011
• Start date: September 2002
• Est. completion date: September 2003

Study information

• Verified date: January 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: September 2003
• Est. primary completion date: September 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder
• Depression
• Depression, Bipolar
• Depressive Disorder

Intervention

Drug:
• SEROQUEL (quetiapine fumarate) Tablets

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States,