Phase 3 /Seroquel SR Acute Mania Monotherapy - US
Sponsored by AstraZeneca
About this trial
Last updated 17 years ago
Study ID
D144CC00004
Status
Completed
Type
Interventional
Phase
Phase 3
Placebo
No
Accepting
18 to 65 Years
All Sexes
Trial Timing
Ended 19 years ago
What is this trial about?
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.
What are the participation requirements?
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.