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

October 21, 2025 updated by: Intra-Cellular Therapies, Inc.

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

554

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 40 mg ITI-007 (Lumateperone)
40 mg ITI-007 (Lumateperone) administered orally as capsules once daily for 6 weeks
Drug: ITI-007 (Lumateperone)
Experimental: 60 mg ITI-007 (Lumateperone)
60 mg ITI-007 (Lumateperone) administered orally as capsules once daily for 6 weeks
Drug: ITI-007 (Lumateperone)
Placebo Comparator: Placebo
Placebo administered orally as visually-matched capsules once daily for 6 weeks
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline to Day 43 in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
Time Frame: 6 weeks
The Montgomery-Åsberg Depression Rating Scale (MADRS) is a clinician-rated 10 item scale to assess depressive symptoms. Each item is rated on a 7-point scale from 0-6. The total score ranges from 0 to 60 with a higher score indicating increased severity of depressive symptoms.
6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to First Sustained Response in Reduction of MADRS Total Score
Time Frame: 6 weeks
6 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline to Day 175 in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
Time Frame: Day 175
The MADRS total score from baseline to Day 175 for patients that rolled over into the extension portion of the study (Part B)
Day 175
Adverse Events
Time Frame: Day 175
Incidence of Treatment-Emergent Adverse Events from baseline to Day 175 for patients that rolled over into the extension portion of the study (Part B)
Day 175

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Intra-Cellular Therapies, Inc.

Investigators

  • Study Director: Susan Kozauer, MD, Intra-Cellular Therapies, Inc. (ITI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2015

Primary Completion (Actual)

January 28, 2019

Study Completion (Actual)

July 24, 2019

Study Registration Dates

First Submitted

November 5, 2015

First Submitted That Met QC Criteria

November 6, 2015

First Posted (Estimated)

November 9, 2015

Study Record Updates

Last Update Posted (Estimated)

November 3, 2025

Last Update Submitted That Met QC Criteria

October 21, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ITI-007-401

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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