Overview

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.