Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients

July 3, 2025 updated by: Intra-Cellular Therapies, Inc.

A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Lumateperone for the Treatment of Major Depressive Episodes (MDEs) Associated With Bipolar I or Bipolar II Disorder (Bipolar Depression) in Pediatric Patients Aged 10 to 17 Years

This is a multicenter, randomized, double-blind, placebo-controlled study in pediatric patients who are experiencing major depressive episodes (MDEs) associated with a primary diagnosis of bipolar I or bipolar II disorder as confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL), according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The study will be conducted in 3 phases:

  • Screening Period (up to 2 weeks) during which patient eligibility will be assessed
  • Double-blind Treatment Period (6 weeks) during which all patients will be randomized to receive lumateperone or placebo in 1:1 ratio.
  • Safety Follow-up Period (1 week) during which all patients will return to the clinic for a safety follow-up (SFU) visit approximately one week after the last dose of study drug.

Study Type

Interventional

Enrollment (Estimated)

384

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 Contact

Study Locations

  • India
      • Ahmedabad, India, 380008
        • Recruiting
        • Clinical Site
      • Aurangabad, India, 431005
        • Recruiting
        • Clinical Site
      • Nashik, India, 422005
        • Recruiting
        • Clinical Site
      • Varanasi, India, 221005
        • Recruiting
        • Clinical Site
  • Serbia
      • Belgrade, Serbia, 11000
        • Recruiting
        • Clinical Site
      • Niš, Serbia, 18000
        • Recruiting
        • Clinical Site
      • Novi Sad, Serbia, 21000
        • Recruiting
        • Clinical Site
  • United States
    • Alabama
      • Dothan, Alabama, United States, 36303
        • Recruiting
        • Clinical Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72204
        • Recruiting
        • Clinical Site
    • California
      • Anaheim, California, United States, 92805
        • Recruiting
        • Clinical Site
      • Redlands, California, United States, 92373
        • Recruiting
        • Clinical Site
      • Sacramento, California, United States, 95817
        • Not yet recruiting
        • Clinical Site
      • San Diego, California, United States, 92103
        • Recruiting
        • Clinical Site
      • West Covina, California, United States, 91790
        • Recruiting
        • Clinical Site
    • Colorado
      • Colorado Springs, Colorado, United States, 80910
        • Recruiting
        • Clinical Site
    • Florida
      • Gainesville, Florida, United States, 32607
        • Not yet recruiting
        • Clinical Site
      • Hialeah, Florida, United States, 33012
        • Recruiting
        • Clinical Site
      • Homestead, Florida, United States, 33030
        • Recruiting
        • Clinical Site
      • Miami, Florida, United States, 33122
        • Recruiting
        • Clinical Site
      • Miami, Florida, United States, 33125
        • Recruiting
        • Clinical Site
      • Miami, Florida, United States, 33176
        • Recruiting
        • Clinical Site
      • Miami, Florida, United States, 33186
        • Recruiting
        • Clinical Site
      • Miami, Florida, United States, 33144
        • Recruiting
        • Clinical Site
      • Miami, Florida, United States, 33130
        • Recruiting
        • Clinical Site
      • Miami, Florida, United States, 33165
        • Recruiting
        • Clinical Site
      • Miami, Florida, United States, 33173
        • Recruiting
        • Clinical Site
      • Miami, Florida, United States, 33134
        • Recruiting
        • Clinical Site
      • Miami Gardens, Florida, United States, 33056
        • Recruiting
        • Clinical Site
      • Miami Lakes, Florida, United States, 33016
        • Recruiting
        • Clinical Site
      • Miami Lakes, Florida, United States, 33014
        • Recruiting
        • Clinical Site
      • Miami Springs, Florida, United States, 33166
        • Recruiting
        • Clinical Site
      • Orlando, Florida, United States, 32803
        • Recruiting
        • Clinical Site
      • West Palm Beach, Florida, United States, 33407
        • Recruiting
        • Clinical Site
    • Georgia
      • Atlanta, Georgia, United States, 30318
        • Recruiting
        • Clinical Site
      • Decatur, Georgia, United States, 30030
        • Recruiting
        • Clinical Site
      • Lawrenceville, Georgia, United States, 30046
        • Recruiting
        • Clinical Site
      • Savannah, Georgia, United States, 31405
        • Recruiting
        • Clinical Site
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Not yet recruiting
        • Clinical Site
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Clinical Site
    • Maryland
      • Baltimore, Maryland, United States, 21229
        • Not yet recruiting
        • Clinical Site
    • Michigan
      • Bloomfield Hills, Michigan, United States, 48302
        • Recruiting
        • Clinical Site
    • Missouri
      • Saint Charles, Missouri, United States, 63304
        • Recruiting
        • Clinical Site
    • Nebraska
      • Lincoln, Nebraska, United States, 68526
        • Recruiting
        • Clinical Site
    • North Carolina
      • Kinston, North Carolina, United States, 28504
        • Not yet recruiting
        • Clinical Site
    • Ohio
      • Avon Lake, Ohio, United States, 44012
        • Recruiting
        • Clinical Site
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • Clinical Site
      • Garfield, Ohio, United States, 44125
        • Recruiting
        • Clinical Site
      • Westlake, Ohio, United States, 44145
        • Recruiting
        • Clinical Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73116
        • Recruiting
        • Clinical Site
      • Oklahoma City, Oklahoma, United States, 73112
        • Recruiting
        • Clinical Site
    • Texas
      • Austin, Texas, United States, 78759
        • Recruiting
        • Clinical Site
      • Flower Mound, Texas, United States, 76028
        • Recruiting
        • Clinical Site
      • Frisco, Texas, United States, 75034
        • Not yet recruiting
        • Clinical Site
      • Houston, Texas, United States, 77089
        • Recruiting
        • Clinical Site
      • Houston, Texas, United States, 77090
        • Recruiting
        • Clinical Site
      • Richmond, Texas, United States, 77407
        • Recruiting
        • Clinical Site
    • Virginia
      • Richmond, Virginia, United States, 23220
        • Recruiting
        • Clinical Site
    • Washington
      • Bellevue, Washington, United States, 98007
        • Recruiting
        • Clinical Site
      • Everett, Washington, United States, 98201
        • Recruiting
        • 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

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Able to provide consent as follows:

    • The Legally Authorized Representative (LAR) must provide written, informed consent.
    • The patient must provide written assent;
  2. Male or female patients 10 to 17 years of age, inclusive;
  3. Have a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM-5-TR) primary diagnosis of bipolar I or bipolar II disorder with a current MDE without psychosis as confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL);
  4. Subject has a lifetime history of at least one manic or hypomanic episode.
  5. Subject's current major depressive episode is ≥ 4 weeks and less than 12 months in duration;
  6. CDRS-R total score ≥ 45 with ≥ 5 on Item 11 (depressed feelings) at Screening and Baseline;
  7. Young Mania Rating Scale (YMRS) score ≤ 15 (with YMRS Item 1 [elevated mood] score ≤ 2) at Screening and Baseline.

Exclusion Criteria:

  1. Has a primary psychiatric diagnosis other than bipolar I or bipolar II disorder. Exception includes:

    • Attention deficit hyperactivity disorder (ADHD). If a subject is taking medications for ADHD, they must have been on a stable treatment regimen of these medication(s) for 30 days prior to screening and the treatment regimen is expected to remain stable throughout the study.
  2. Intellectual disability based on Investigator opinion and DSM-5 criteria
  3. Patient has been hospitalized for a bipolar manic episode within the 30 days prior to randomization;
  4. Demonstrates a ≥ 25% decrease (improvement) in the CDRS-R total score between Screening and Baseline visits, or the CDRS-R is below 45 at Baseline;

  5. In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during his/her participation in the study or

    1. At Screening, the patient scores "yes" on Suicidal Ideation Items 3, 4, or 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) within 6 months prior to Screening or, at Baseline, the patient scores "yes" on Suicidal Ideation Items 3, 4, or 5 since the Screening Visit;
    2. At Screening, the patient has had 1 or more suicidal attempts within the 2 years prior to Screening; or
    3. At Screening or Baseline, scores > 3 on Item 13 (suicidal ideation) on the CDRS-R; or
    4. The patient is considered to be an imminent danger to him/herself or others.

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
Placebo Comparator: Placebo
Matching placebo
Drug: Placebo
Matching placebo administered orally, once daily.
Experimental: Lumateperone
Lumateperone 42 mg for patient ages 13-17 years and Lumateperone 21 mg for patient ages 10-12 years.
Drug: Lumateperone
Lumateperone administered orally, once daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Children's Depression Rating Scale-Revised (CDRS-R)
Time Frame: Week 6
The Children's Depression Rating Scale-Revised is an observer-rated, 17-item semi-structured scale for pediatric patients. The scale comprises cognitive, somatic, affective, and psychomotor symptoms of depression. Items are rated for severity on a 7-point scale (1 to 7) for 14 items and on a 5-point scale (1 to 5) for three items. Total scores range from 7 to 113.
Week 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Global Impression Scale-Severity (CGI-S)
Time Frame: Week 6
The CGI-S is a clinician-rated scale to assess a patient's overall mental health. The scale ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
Week 6

Collaborators and Investigators

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

Sponsor

Intra-Cellular Therapies, Inc.

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)

May 13, 2024

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

April 15, 2024

First Submitted That Met QC Criteria

April 15, 2024

First Posted (Actual)

April 18, 2024

Study Record Updates

Last Update Posted (Estimated)

July 8, 2025

Last Update Submitted That Met QC Criteria

July 3, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ITI-007-421

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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