At a glance
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A Double-Blind, Placebo-Controlled Study of Cariprazine (RGH-188) as Adjunctive Therapy in Major Depressive Disorder
In Brief
A Phase 2 clinical trial evaluating Placebo and Cariprazine for Major Depressive Disorder. Completed, enrolled 819 participants across 72 sites in 6 countries.
Detailed Summary
An outpatient study to evaluate the safety and efficacy of cariprazine as adjunct to antidepressant therapy (ADT) in participants with major depressive disorder (MDD) who have an inadequate response to ADT alone. This clinical study compared cariprazine + ADT with placebo + ADT in outpatients with a diagnosis of MDD and an inadequate response to ADT. The study consisted of approximately 2 weeks of screening and washout followed by 8 weeks of double-blind treatment followed by a 1 week safety follow-up.
Study Details
Timeline
Interventions
Placebo was supplied in capsules
Cariprazine was supplied in capsules.