Status:
COMPLETED
Efficacy and Safety of Quetiapine Versus Quetiapine Plus Lithium in Bipolar Depression
Lead Sponsor:
AstraZeneca
Conditions:
Acute Bipolar Depression
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to compare the efficacy of quetiapine fumarate monotherapy with quetiapine fumarate in combination with lithium in the treatment of a major depressive episode in patients ...
Eligibility Criteria
Inclusion
- Outpatients that meet the diagnostic criteria for bipolar disorder I and bipolar disorder II with the most recent episode depressed
- The total score of the scale that's used for the evaluation of depression (HAM-D) should be ≥20
- The total score of the scale that' used for the evaluation of mania (YMRS) should be ≤12
Exclusion
- Patients with a current DSM-IV-TR Axis I disorder other than bipolar disorder within 6 months of enrollment. Patients who pose a current serious suicidal or homicidal risk
- Use of drugs that induce or inhibit the hepatic metabolizing enzymes within 14 days before randomisation
- Patients who are unable to discontinue all psychoactive medications, including antidepressants, antipsychotics, and mood stabilizers at least 7 days prior to randomisation and consistent with the pharmacokinetics of the drug
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
421 Patients enrolled
Trial Details
Trial ID
NCT00883493
Start Date
April 1 2009
End Date
March 1 2011
Last Update
July 11 2012
Active Locations (24)
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1
Research Site
La Plata, Buenos Aires, Argentina
2
Research Site
Godoy Cruz, Mendoza Province, Argentina
3
Research Site
Mendoza, Mendoza Province, Argentina
4
Research Site
Caba, Argentina