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

August 27, 2026 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

  • Colombia
      • Barranquilla, Colombia, 080020
        • Recruiting
        • Centro de Investigaciones y Proyectos en Neurociencias CIPNA
      • Bello, Colombia, 051053
        • Recruiting
        • Empresa Social del Estado Hospital Mental de Antioquia Maria Upegui HOMO
      • Bogotá, Colombia, 111166
        • Completed
        • Centro de Investigaciones del Sistema Nervioso Grupo Cisne Ltda.
      • Pereira, Colombia, 660002
        • Suspended
        • Psynapsis Salud Mental S.A.
  • India
      • Ahmedabad, India, 380008
        • Suspended
        • Ratandeep Surgical Hospital And Endoscopy Clinic
      • Aurangabad, India, 431005
        • Suspended
        • Society for Psychiatric Update and Research Shanti Nursing Home
      • Nashik, India, 422005
        • Suspended
        • Chopda Medicare & Research Centre
      • Varanasi, India, 221005
        • Suspended
        • Deva Institute of Healthcare And Research Pvt Ltd
  • Serbia
      • Belgrade, Serbia, 11000
        • Active, not recruiting
        • Clinic of Neurology and Psychiatry for Children and Youth
      • Belgrade, Serbia, 11000
        • Active, not recruiting
        • Institute of Mental Health Serbia
      • Niš, Serbia, 18000
        • Active, not recruiting
        • University Clinical Center Nis
      • Novi Sad, Serbia, 21000
        • Suspended
        • Clinical Center of Vojvodina
  • United States
    • Alabama
      • Dothan, Alabama, United States, 36303
        • Recruiting
        • Harmonex Neuroscience Research
    • Arkansas
      • Little Rock, Arkansas, United States, 72204
        • Recruiting
        • Pillar Clinical Research, LLC
    • California
      • Anaheim, California, United States, 92805
        • Recruiting
        • Advanced Research Center, Inc
      • Redlands, California, United States, 92373
        • Recruiting
        • Inland Psychiatric Medical Group Inc
      • Sacramento, California, United States, 95817
        • Recruiting
        • UC Davis Health System
      • San Diego, California, United States, 92103
        • Completed
        • University of California San Diego Medical Center
      • West Covina, California, United States, 91790
        • Recruiting
        • Next Level Clinical Trials, LLC
    • Colorado
      • Colorado Springs, Colorado, United States, 80910
        • Completed
        • MCB Clinical Research Centers LLC
    • Florida
      • Fort Myers, Florida, United States, 33901
        • Suspended
        • Royal Palm Clinical Research
      • Hialeah, Florida, United States, 33012
        • Completed
        • United Research Institute
      • Homestead, Florida, United States, 33033
        • Suspended
        • Advanced Research Institute of Miami
      • Miami, Florida, United States, 33176
        • Recruiting
        • Links Clinical Trials
      • Miami, Florida, United States, 33122
        • Suspended
        • Vital Care Research
      • Miami, Florida, United States, 33130
        • Recruiting
        • Care Research Center Inc
      • Miami, Florida, United States, 33165
        • Suspended
        • AP Medical Research
      • Miami, Florida, United States, 33125
        • Suspended
        • Columbus Clinical Services LLC
      • Miami, Florida, United States, 33134
        • Recruiting
        • HealthMed Clinical Center Inc
      • Miami, Florida, United States, 33144
        • Completed
        • Ocean Blue Medical Research Center Inc.
      • Miami, Florida, United States, 33166
        • Recruiting
        • Envision Trials LLC
      • Miami, Florida, United States, 33173
        • Completed
        • GTL Medical and Research Group
      • Miami, Florida, United States, 33186
        • Completed
        • SouthGen Clinical Research LLC
      • Miami Gardens, Florida, United States, 33056
        • Recruiting
        • New Med Research Inc
      • Miami Gardens, Florida, United States, 33169
        • Recruiting
        • The Angel Medical Research Corporation
      • Miami Lakes, Florida, United States, 33014
        • Recruiting
        • Riveldi Biomedical Research
      • Orlando, Florida, United States, 32803
        • Recruiting
        • APG Research LLC
      • West Palm Beach, Florida, United States, 33407
        • Recruiting
        • Health Synergy Clinical Research
    • Georgia
      • Atlanta, Georgia, United States, 30030
        • Recruiting
        • CenExeli Research LLC
      • Atlanta, Georgia, United States, 30318
        • Completed
        • Advanced Discovery Research
      • Lawrenceville, Georgia, United States, 30046
        • Completed
        • Salveo Integrative Health Inc
      • Savannah, Georgia, United States, 31405
        • Recruiting
        • CenExeli Research LLC 1
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Ann & Robert H. Lurie Children's Hospital of Chicago
      • Elgin, Illinois, United States, 60123
        • Recruiting
        • Revive Research Institute
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Completed
        • Indiana University
    • Maryland
      • Baltimore, Maryland, United States, 21229
        • Completed
        • MTP Psychiatry LLC
    • Michigan
      • Bloomfield Hills, Michigan, United States, 48302
        • Recruiting
        • Neurobehavioral Medicine Group
    • Missouri
      • Saint Charles, Missouri, United States, 63304
        • Recruiting
        • Midwest Research Group
      • St Louis, Missouri, United States, 63110
        • Completed
        • Washington University School of Medicine Child and Adolescent Psychiatry Clinic
    • Nebraska
      • Lincoln, Nebraska, United States, 68526
        • Recruiting
        • Alivation Research LLC
    • New York
      • New York, New York, United States, 10016
        • Recruiting
        • NYU Child Study Center
    • Ohio
      • Avon Lake, Ohio, United States, 44012
        • Completed
        • Haidar Almhana Nieding
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • University of Cincinnati Medical Center
      • Garfield Heights, Ohio, United States, 44125
        • Recruiting
        • Charak Center for Health and Wellness
      • Westlake, Ohio, United States, 44145
        • Completed
        • Westlake America Clinic
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73116
        • Completed
        • Cutting Edge Research Group
      • Oklahoma City, Oklahoma, United States, 73116
        • Recruiting
        • Sooner Clinical Research
      • Oklahoma City, Oklahoma, United States, 73112
        • Recruiting
        • SP Research, PLLC (dba Rivus Wellness & Research Institute)
    • Texas
      • Austin, Texas, United States, 78701
        • Recruiting
        • The University of Texas at Austin
      • Austin, Texas, United States, 78759
        • Completed
        • BioBehavioral Research of Austin PC
      • Beaumont, Texas, United States, 77701
        • Recruiting
        • REX Clinical Trials LLC
      • Flower Mound, Texas, United States, 76028
        • Completed
        • North Pointe Psychiatry
      • Houston, Texas, United States, 77090
        • Recruiting
        • Red Oak Psychiatry Associates
      • Houston, Texas, United States, 77089
        • Recruiting
        • Kaleidoscope Clinical Research
      • Richmond, Texas, United States, 77407
        • Recruiting
        • Perceptive Pharma Research
    • Virginia
      • Richmond, Virginia, United States, 23220
        • Recruiting
        • Virginia Commonwealth University
    • Washington
      • Bellevue, Washington, United States, 98007
        • Recruiting
        • Northwest Clinical Research Center
      • Everett, Washington, United States, 98201
        • Recruiting
        • Core Clinical Research

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.

Investigators

  • Study Director: Intra-Cellular Therapies, Inc. Clinical Trial, 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 14, 2024

Primary Completion (Estimated)

October 31, 2031

Study Completion (Estimated)

October 31, 2031

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 (Actual)

August 28, 2026

Last Update Submitted That Met QC Criteria

August 27, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ITI-007-421 (Other Identifier: Janssen Research & Development, LLC)

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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