drugset / Trial / NCT01587066

Efficacy of Quetiapine XR Versus Divalproex on Clinical Outcome Quality of Sleep and Quality of Life in Bipolar Depression

NCT01587066

Phase 4 Withdrawn Bo-Hyun Yoon
RandomizedParallel-groupOpen-labelTreatment

Summary

Quetiapine is one of atypical antipsychotics with good efficacy and better side effect profiles than conventional antipsychotics, so it is being widely used beyond the treatment of schizophrenia. Recently, the BOLDER I and II study showed that quetiapine monotherapy is an effective and well-tolerated treatment for depressive episodes in bipolar disorder. However, most c1inicians did not have confidence with quetiapine monotherapy yet, and most practice guidelines recommend the monotherapy with mood stabilizer as the first-line treatment. The Korean medication algorithm for bipolar disorder published in 2006 also recommend the monotherapy with lithium, divalproex, or lamotrigine in the treatment of mild to moderate depressive episode of bipolar disorder. Therefore, the aim of this study is investigating the efficacy and safety of quetiapine monotherapy when compared with mood stabilizer monotherapy. In addition, the investigators are going to reveal the quality of sleep and quality of life, of the two groups of patients.

Timeline

Start
2010-08
Primary completion
2011-08
Completion
2011-09

Drugs

EvaluationDrugModalityDoseRoute
Comparator Divalproex Sodium Small molecule
Comparator Quetiapine Small molecule

Indications