Status:
COMPLETED
Seroquel in Bipolar Depression Versus SSRI
Lead Sponsor:
AstraZeneca
Conditions:
Bipolar Disorder
Bipolar Depression
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine whether quetiapine is effective and safe in the acute treatment of bipolar depression and whether the effect is maintained when treatment is continued.
Eligibility Criteria
Inclusion
- Male and female out-patients aged 18 to 65 years inclusive
- Diagnosis of Bipolar Disorder (Bipolar I or Bipolar II), most recent episode depressed
Exclusion
- Current period of depression lasting less than 4 weeks or more than 12 months
- Use of prohibited medication
- Substance or alcohol dependence or abuse
- Current suicide risk or suicide attempt within 6 months
- Breast feeding or pregnancy
- Clinically relevant disease or clinical finding
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2007
Estimated Enrollment :
676 Patients enrolled
Trial Details
Trial ID
NCT00119652
Start Date
May 1 2005
End Date
May 1 2007
Last Update
January 4 2013
Active Locations (55)
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1
Research Site
Phoenix, Arizona, United States
2
Research Site
Little Rock, Arkansas, United States
3
Research Site
National City, California, United States
4
Research Site
San Clemente, California, United States