drugset / Trial / NCT02046564

Assess the Efficacy and Safety of ASC-01 in Patients With Major Depressive Disorder

NCT02046564

Phase 3 Completed 412 enrolled Otsuka Pharmaceutical Co., Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

To evaluate the efficacy and the safety of ASC-01 (aripiprazole/sertraline combination) compared to sertraline monotherapy in patients with major depressive disorders who have responded incompletely to sertraline monotherapy.

Timeline

Start
2014-02
Primary completion
2016-09
Completion
2016-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Aripiprazole Other / unclassified 3 mg Oral
Subject Aripiprazole Other / unclassified 12 mg Oral
Background Sertraline Small molecule 100 mg Oral