Status:
COMPLETED
Seroquel in Bipolar Depression Versus Lithium
Lead Sponsor:
AstraZeneca
Conditions:
Bipolar Disorder
Bipolar Depression
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
This study is being carried out to see if quetiapine fumarate (Seroquel) is effective in treating bipolar depression during an 8-week acute phase compared with placebo and lithium, followed by continu...
Eligibility Criteria
Inclusion
- Patients with a diagnosis of bipolar I disorder or bipolar II disorder, currently depressed, aged 18 to 65 years old and outpatient status at enrolment and randomization.
Exclusion
- Patients with a current DSM-IV Axis I disorder other than bipolar disorder that is symptomatic or requiring treatment within 6 months of enrolment,
- History of non-response to an adequate treatment
- Patients who, in the investigator's judgment pose a current serious suicidal or homicidal risk
- Pregnancy or lactation
- Clinically relevant disease or clinical finding
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
End Date :
May 1 2007
Estimated Enrollment :
672 Patients enrolled
Trial Details
Trial ID
NCT00206141
Start Date
August 1 2005
End Date
May 1 2007
Last Update
January 4 2013
Active Locations (76)
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1
Research Site
Kelowna, British Columbia, Canada
2
Research Site
Sydney, Nova Scotia, Canada
3
Research Site
Greater Sudbury, Ontario, Canada
4
Research Site
Markham, Ontario, Canada