NCT02600494

Clinical Trial Evaluating ITI-007 (Lumateperone) as a Monotherapy for the Treatment of Bipolar Depression

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study With an Open-Label Extension to Assess the Efficacy and Safety of ITI-007 Monotherapy in the Treatment of Patients With Major Depressive Episodes Associated With Bipolar I or Bipolar II Disorder (Bipolar Depression)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 554 (actual)
• Sponsor: Intra-Cellular Therapies, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bipolar Depression

Interventions

Type	Name	Description
DRUG	ITI-007 (Lumateperone)
DRUG	Placebo

Timeline

• Start date: 2015-12-15
• Primary completion: 2019-01-28
• Completion: 2019-07-24
• First posted: 2015-11-09
• Last updated: 2025-11-03
• Results posted: 2025-11-03

Locations

55 sites across 1 country: United States

Regulatory

• FDA-regulated drug study