Phase III/Seroquel SR Bipolar Depression Monotherapy - US

• Status: Completed
• Trial end date: 2007-06-01
• 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 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.

• 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 1 disorder or Bipolar 11 disorder

• Outpatient status at enrollment

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.