Phase III/Seroquel SR Bipolar Depression Monotherapy - US

Phase 3

Completed

• Conditions: Affective Psychosis, Bipolar; Depression, Bipolar; Manic-Depressive Psychosis; Psychoses, Manic-Depressive

• Registration Number: NCT00422214
• Lead Sponsor: AstraZeneca

Brief Summary

The purpose of this study is to determine the safety and efficacy of sustained-release quetiapine fumarate (Seroquel®) in the treatment of patients with Acute Bipolar Depression for 8 weeks.

PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2007-01-12
• Study First Submitted QC: 2007-01-12
• Study First Posted: 2007-01-15
• Study Completion: 2007-06
• Status Verified: 2009-03
• Last Update Submitted: 2009-03-24
• Last Update Posted: 2009-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Provision of written informed consent
• Documented diagnosis of Bipolar 1 disorder or Bipolar 11 disorder
• Outpatient status at enrollment

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Exclusion Criteria

• Patients with >8 mood episodes during the past 12 years
• Use of prohibited medications
• Substance or alcohol abuse or dependence
• Current suicide risk or suicide attempt within last 6 months.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from baseline in depression symptoms by final visit as measured by the MADRS total score

Secondary Outcome Measures

Name	Time	Method
Change from baseline to final visit on the MADRS total score MADRS item scores, CGI-BP-S, CGI-BP-C

Trial Locations

Locations (1)

Research Site; 🇺🇸 South Kirkland, Washington, United States