Status:
COMPLETED
Quetiapine XR Versus Sertraline in Acute Bipolar Depression as add-on Therapy
Lead Sponsor:
AstraZeneca
Conditions:
Bipolar Disorder
Bipolar Depression
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
Prospective, open-label, controlled (active comparator), randomized study of 8 weeks follow-up for the evaluation of the efficacy of extended release quetiapine (quetiapine XR) versus Sertraline in ad...
Eligibility Criteria
Inclusion
- Adult ambulatory patients diagnosed of bipolar disorder I or II, current depressive episode (DSM-IV-TR 4ª Ed: 296.5x or 296.89 codes)
- Have been treated with only one mood stabilizer (lithium or valproate) in optimal and stable doses during at least the previous 4 weeks to randomization
- Hamilton Depression Rating Scale (HDRS-17) total score ≥ 20 and Young Mania Rating Scale (YMRS) total score ≤ 14 at the screening and randomization visits - Informed consent signed
Exclusion
- Patients with any axis I or II Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text revision (DSM-IV-TR) diagnoses different from bipolar disorder I or II - Length of current depressive episode less than 2 weeks or more than 12 months
- Having been treated with more than one mood stabilizer or any mood stabilizer other than Lithium or valproate, any antidepressant, any antipsychotic or any CP450-3A inductor/inhibitor within the 7 days period prior to randomization
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00857584
Start Date
May 1 2009
End Date
February 1 2011
Last Update
April 18 2012
Active Locations (4)
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1
Research Site
Vitoria-Gasteiz, Basque Country, Spain
2
Research Site
Santander, Cantabria, Spain
3
Research Site
Zamora, Castille and León, Spain
4
Research Site
Vigo, Galicia, Spain