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: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Intra-Cellular Therapies, Inc.

Criteria

Major Inclusion Criteria:

• male or female subjects of any race, ages 18-75 inclusive, with a clinical diagnosis of Bipolar I or Bipolar II disorder

• experiencing a current major depressive episode

Major Exclusion Criteria:

• any subject unable to provide informed consent

• any female subject who is pregnant or breast-feeding

• any subject judged to be medically inappropriate for study participation