Status:
COMPLETED
Phase 3 /Seroquel SR Acute Mania Monotherapy - US
Lead Sponsor:
AstraZeneca
Conditions:
Affective Psychosis, Bipolar
Manic Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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: ...
Eligibility Criteria
Inclusion
- 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
- \>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.
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
447 Patients enrolled
Trial Details
Trial ID
NCT00422123
Start Date
January 1 2007
End Date
July 1 2007
Last Update
March 25 2009
Active Locations (51)
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1
Research Site
Phoenix, Arizona, United States
2
Research Site
Little Rock, Arkansas, United States
3
Research Site
Cerritos, California, United States
4
Research Site
Garden Grove, California, United States