Phase 3 /Seroquel SR Acute Mania Monotherapy - US

• Status: Completed
• Trial end date: 2007-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Quetiapine Fumarate

Criteria

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

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.