Phase 3 /Seroquel SR Acute Mania Monotherapy - US

Phase 3

Completed

• Conditions: Manic State; Affective Psychosis, Bipolar; Manic Disorder; Manic-Depressive Psychosis; Mania; Psychoses, Manic-Depressive

• Registration Number: NCT00422123
• 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 Mania for 3 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: 2007-01
• Study First Submitted: 2007-01-12
• Study First Submitted QC: 2007-01-12
• Study First Posted: 2007-01-15
• Study Completion: 2007-07
• Status Verified: 2009-03
• Last Update Submitted: 2009-03-24
• Last Update Posted: 2009-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 447

Inclusion Criteria

• Provision of written informed consent
• Documented diagnosis of Bipolar Disorder, with most recent episode being manic or mixed
• Inpatient hospital admission for the first 4 days of study treatment

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Exclusion Criteria

• >8 mood episodes within the last 12 months
• Use of prohibited medication
• 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 to final visit in the YMRS total score

Secondary Outcome Measures

Name	Time	Method
Change from baseline to each visit in YMRS score and changes of YMRS subscores and changes in MADRS.

Trial Locations

Locations (2)

Research Sitew; 🇺🇸 Fort Lauderdale, Florida, United States

Research Site; 🇺🇸 Bellevue, Washington, United States