drugset / Trial / NCT00857584
Quetiapine XR Versus Sertraline in Acute Bipolar Depression as add-on Therapy
RandomizedParallel-groupOpen-labelTreatment
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 addition to previous mood stabilizer treatment (lithium or valproate at stable and clinically therapeutic blood levels) in the treatment of the adult bipolar depression. This multicentric study will be featured in two sites in Spain.
Timeline
- Start
- 2009-05
- Primary completion
- 2011-02
- Completion
- 2011-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Quetiapine | Small molecule | 300 mg | Oral |
| Subject | Quetiapine | Small molecule | 600 mg | Oral |
| Comparator | Sertraline | Small molecule | 50 mg | Oral |
| Comparator | Sertraline | Small molecule | 200 mg | Oral |
| Background | Lithium | Unknown | — | — |
| Background | Valproate | Small molecule | — | — |