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

Bipolar Depression Clinical Trial

Official title:

Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02600494
• Other study ID #: ITI-007-401
• Status: Completed
• Phase: Phase 3
• Start date: December 15, 2015
• Est. completion date: July 24, 2019

Study information

• Verified date: April 2021
• Source: Intra-Cellular Therapies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 554
• Est. completion date: July 24, 2019
• Est. primary completion date: January 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Depression
• Bipolar Disorder
• Depression
• Depressive Disorder

Intervention

Drug:
• ITI-007 (Lumateperone)

• Placebo

Locations

Country	Name	City	State
United States	Clinical Site	Allentown	Pennsylvania
United States	Clinical Site	Atlanta	Georgia
United States	Clinical Site	Austin	Texas
United States	Clinical Site	Baltimore	Maryland
United States	Clinical Site	Berlin	New Jersey
United States	Clinical Site	Boston	Massachusetts
United States	Clinical Site	Bradenton	Florida
United States	Clinical Site	Brooklyn	New York
United States	Clinical Site	Cedarhurst	New York
United States	Clinical Site	Cerritos	California
United States	Clinical Site	Cherry Hill	New Jersey
United States	Clinical Site	Chicago	Illinois
United States	Clinical Site	Cincinnati	Ohio
United States	Clinical Site	Cleveland	Ohio
United States	Clinical Site	Colorado Springs	Colorado
United States	Clinical Site	Culver City	California
United States	Clinical Site	Dallas	Texas
United States	Clinical Site	Dayton	Ohio
United States	Clinical Site	Everett	Washington
United States	Clinical Site	Fort Myers	Florida
United States	Clinical Site	Garden Grove	California
United States	Clinical Site	Garfield Heights	Ohio
United States	Clinical Site	Hoffman Estates	Illinois
United States	Clinical Site	Houston	Texas
United States	Clinical Site	Jacksonville	Florida
United States	Clinical Site	Lake Charles	Louisiana
United States	Clinical Site	Las Vegas	Nevada
United States	Clinical Site	Lauderhill	Florida
United States	Clinical Site	Lemon Grove	California
United States	Clinical Site	Little Rock	Arkansas
United States	Clinical Site	Marlton	New Jersey
United States	Clinical Site	Memphis	Tennessee
United States	Clinical Site	Miami	Florida
United States	Clinical Site	National City	California
United States	Clinical Site	New York	New York
United States	Clinical Site	Norristown	Pennsylvania
United States	Clinical Site	North Miami	Florida
United States	Clinical Site	O'Fallon	Missouri
United States	Clinical Site	Oakland	California
United States	Clinical Site	Oceanside	California
United States	Clinical Site	Oklahoma City	Oklahoma
United States	Clinical Site	Orange	California
United States	Clinical Site	Orlando	Florida
United States	Clinical Site	Petersburg	Virginia
United States	Clinical Site	Philadelphia	Pennsylvania
United States	Clinical Site	Pico Rivera	California
United States	Clinical Site	Riverside	California
United States	Clinical Site	Rochester	New York
United States	Clinical Site	Rogers	Arkansas
United States	Clinical Site	Saint Louis	Missouri
United States	Clinical Site	San Diego	California
United States	Clinical Site	San Marcos	California
United States	Clinical Site	Santa Rosa	California
United States	Clinical Site	Staten Island	New York
United States	Clinical Site	Toms River	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Intra-Cellular Therapies, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Montgomery-Åsberg Depression Rating Scale (MADRS)		6 weeks