Status:
COMPLETED
Phase III/Seroquel SR Bipolar Depression Monotherapy - US
Lead Sponsor:
AstraZeneca
Conditions:
Affective Psychosis, Bipolar
Depression, Bipolar
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 Depression for 8 weeks. PLEASE N...
Eligibility Criteria
Inclusion
- Provision of written informed consent
- Documented diagnosis of Bipolar 1 disorder or Bipolar 11 disorder
- Outpatient status at enrollment
Exclusion
- 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.
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
End Date :
June 1 2007
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00422214
Start Date
December 1 2006
End Date
June 1 2007
Last Update
March 25 2009
Active Locations (54)
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1
Research Site
Birmingham, Alabama, United States
2
Research Site
Phoenix, Arizona, United States
3
Research Site
Scottsdale, Arizona, United States
4
Research Site
Little Rock, Arkansas, United States