NCT00422123CompletedPhase 3
A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo Controlled, Phase III Study of the Efficacy and Safety of Quetiapine Fumarate (SEROQUEL®) Sustained-Release as Monotherapy in Adult Patients With Acute Bipolar Mania
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 447
- Locations
- 51
- Primary Endpoint
- Change from baseline to final visit in the YMRS total score
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Change from baseline to final visit in the YMRS total score
Secondary Outcomes
- Change from baseline to each visit in YMRS score and changes of YMRS subscores and changes in MADRS.
Investigators
Study Sites (51)
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