Clinical Trial Evaluating ITI-007 (Lumateperone) as a Monotherapy for the Treatment of Bipolar Depression
Status:
Completed
Trial end date:
2019-07-24
Target enrollment:
Participant gender:
Summary
The study will evaluate the efficacy and safety of ITI-007 (Lumateperone) in patients
diagnosed with Bipolar I or Bipolar II disorder having a major depressive episode. The study
will be conducted in two parts, Part A and Part B. Part A is a randomized, double-blind,
placebo-controlled study. In Part B, patients who safely complete participation in part A may
be enrolled in an open-label extension.