NCT03249376

Lumateperone Monotherapy for the Treatment of Bipolar Depression Conducted Globally

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess 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) Conducted Globally

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 381 (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 in a randomized, double-blind, parallel-group, placebo-controlled, multi-center study in patients diagnosed with Bipolar I or Bipolar II disorder having a major depressive episode.

Conditions

• Bipolar Depression

Interventions

Type	Name	Description
DRUG	Lumateperone	Lumateperone 42 mg (ITI-007 60 mg tosylate)
OTHER	Placebo	Placebo

Timeline

• Start date: 2017-11-27
• Primary completion: 2019-03-01
• Completion: 2019-03-01
• First posted: 2017-08-15
• Last updated: 2022-06-03
• Results posted: 2022-06-03

Locations

47 sites across 6 countries: United States, Bulgaria, Colombia, Russia, Serbia, Ukraine

Regulatory

• FDA-regulated drug study