Clinical Trial Evaluating Lumateperone Monotherapy in the Treatment of Bipolar Depression or Major Depressive Disorder
Status:
Recruiting
Trial end date:
2022-12-01
Target enrollment:
Participant gender:
Summary
This is a randomized, double-blind, placebo-controlled, multicenter study to evaluate the
efficacy and safety of lumateperone monotherapy in the treatment of patients with major
depressive episodes associated with Bipolar I or Bipolar II Disorder (Bipolar Depression) or
major depressive disorder (MDD) who also meet the Diagnostic and Statistical Manual of Mental
Disorder, 5th Edition (DSM-5) criteria for mixed-features. The study consists of a Screening
Period, a Double-blind Treatment Period, and a Safety Follow-up Period.