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

NCT06372964 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: ITI-007-421
• Study Type: interventional
• Target: 384
• Locations: 4 countries
• Sites: 68

Brief Summary

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).

Conditions

Bipolar Depression

Outcome Measures

Primary Outcomes (1)

• Children's Depression Rating Scale-Revised (CDRS-R)

  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 Outcomes (1)

• Clinical Global Impression Scale-Severity (CGI-S)

  Week 6

Study Arms (2)

Lumateperone

EXPERIMENTAL

Lumateperone 42 mg for patient ages 13-17 years and Lumateperone 21 mg for patient ages 10-12 years.

Drug: Lumateperone

Placebo

PLACEBO COMPARATOR

Matching placebo

Drug: Placebo

Interventions

Lumateperone DRUG

Lumateperone administered orally, once daily.

Lumateperone

Placebo DRUG

Matching placebo administered orally, once daily.

Placebo

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Able to provide consent as follows:
• The Legally Authorized Representative (LAR) must provide written, informed consent.
• The patient must provide written assent;
• Male or female patients 10 to 17 years of age, inclusive;
• 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);
• Subject has a lifetime history of at least one manic or hypomanic episode.
• Subject's current major depressive episode is ≥ 4 weeks and less than 12 months in duration;
• CDRS-R total score ≥ 45 with ≥ 5 on Item 11 (depressed feelings) at Screening and Baseline;
• Young Mania Rating Scale (YMRS) score ≤ 15 (with YMRS Item 1 \[elevated mood\] score ≤ 2) at Screening and Baseline.

You may not qualify if:

• 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.
• Intellectual disability based on Investigator opinion and DSM-5 criteria
• Patient has been hospitalized for a bipolar manic episode within the 30 days prior to randomization;
• 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;
• In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during his/her participation in the study or
• 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;
• At Screening, the patient has had 1 or more suicidal attempts within the 2 years prior to Screening; or
• At Screening or Baseline, scores \> 3 on Item 13 (suicidal ideation) on the CDRS-R; or
• The patient is considered to be an imminent danger to him/herself or others.

Sponsors & Collaborators

• Intra-Cellular Therapies, Inc.: lead

Study Sites (68)

Harmonex Neuroscience Research

Dothan, Alabama, 36303, United States

RECRUITING

Pillar Clinical Research, LLC

Little Rock, Arkansas, 72204, United States

RECRUITING

Advanced Research Center, Inc

Anaheim, California, 92805, United States

RECRUITING

Inland Psychiatric Medical Group Inc

Redlands, California, 92373, United States

RECRUITING

UC Davis Health System

Sacramento, California, 95817, United States

RECRUITING

University of California San Diego Medical Center

San Diego, California, 92103, United States

COMPLETED

Next Level Clinical Trials, LLC

West Covina, California, 91790, United States

RECRUITING

MCB Clinical Research Centers LLC

Colorado Springs, Colorado, 80910, United States

COMPLETED

Royal Palm Clinical Research

Fort Myers, Florida, 33901, United States

SUSPENDED

United Research Institute

Hialeah, Florida, 33012, United States

COMPLETED

Advanced Research Institute of Miami

Homestead, Florida, 33033, United States

SUSPENDED

Vital Care Research

Miami, Florida, 33122, United States

SUSPENDED

Columbus Clinical Services LLC

Miami, Florida, 33125, United States

SUSPENDED

Care Research Center Inc

Miami, Florida, 33130, United States

RECRUITING

HealthMed Clinical Center Inc

Miami, Florida, 33134, United States

RECRUITING

Ocean Blue Medical Research Center Inc.

Miami, Florida, 33144, United States

COMPLETED

AP Medical Research

Miami, Florida, 33165, United States

SUSPENDED

Envision Trials LLC

Miami, Florida, 33166, United States

RECRUITING

GTL Medical and Research Group

Miami, Florida, 33173, United States

COMPLETED

Links Clinical Trials

Miami, Florida, 33176, United States

RECRUITING

SouthGen Clinical Research LLC

Miami, Florida, 33186, United States

COMPLETED

New Med Research Inc

Miami Gardens, Florida, 33056, United States

RECRUITING

The Angel Medical Research Corporation

Miami Gardens, Florida, 33169, United States

RECRUITING

Riveldi Biomedical Research

Miami Lakes, Florida, 33014, United States

RECRUITING

APG Research LLC

Orlando, Florida, 32803, United States

RECRUITING

Health Synergy Clinical Research

West Palm Beach, Florida, 33407, United States

RECRUITING

CenExeli Research LLC

Atlanta, Georgia, 30030, United States

RECRUITING

Advanced Discovery Research

Atlanta, Georgia, 30318, United States

COMPLETED

Salveo Integrative Health Inc

Lawrenceville, Georgia, 30046, United States

COMPLETED

CenExeli Research LLC 1

Savannah, Georgia, 31405, United States

RECRUITING

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

RECRUITING

Revive Research Institute

Elgin, Illinois, 60123, United States

RECRUITING

Indiana University

Indianapolis, Indiana, 46202, United States

COMPLETED

MTP Psychiatry LLC

Baltimore, Maryland, 21229, United States

COMPLETED

Neurobehavioral Medicine Group

Bloomfield Hills, Michigan, 48302, United States

RECRUITING

Midwest Research Group

Saint Charles, Missouri, 63304, United States

RECRUITING

Washington University School of Medicine Child and Adolescent Psychiatry Clinic

St Louis, Missouri, 63110, United States

COMPLETED

Alivation Research LLC

Lincoln, Nebraska, 68526, United States

RECRUITING

NYU Child Study Center

New York, New York, 10016, United States

RECRUITING

Haidar Almhana Nieding

Avon Lake, Ohio, 44012, United States

COMPLETED

University of Cincinnati Medical Center

Cincinnati, Ohio, 45219, United States

RECRUITING

Charak Center for Health and Wellness

Garfield Heights, Ohio, 44125, United States

RECRUITING

Westlake America Clinic

Westlake, Ohio, 44145, United States

COMPLETED

SP Research, PLLC (dba Rivus Wellness & Research Institute)

Oklahoma City, Oklahoma, 73112, United States

RECRUITING

Cutting Edge Research Group

Oklahoma City, Oklahoma, 73116, United States

COMPLETED

Sooner Clinical Research

Oklahoma City, Oklahoma, 73116, United States

RECRUITING

The University of Texas at Austin

Austin, Texas, 78701, United States

RECRUITING

BioBehavioral Research of Austin PC

Austin, Texas, 78759, United States

RECRUITING

REX Clinical Trials LLC

Beaumont, Texas, 77701, United States

RECRUITING

North Pointe Psychiatry

Flower Mound, Texas, 76028, United States

COMPLETED

Kaleidoscope Clinical Research

Houston, Texas, 77089, United States

RECRUITING

Red Oak Psychiatry Associates

Houston, Texas, 77090, United States

RECRUITING

Perceptive Pharma Research

Richmond, Texas, 77407, United States

RECRUITING

Virginia Commonwealth University

Richmond, Virginia, 23220, United States

RECRUITING

Northwest Clinical Research Center

Bellevue, Washington, 98007, United States

RECRUITING

Core Clinical Research

Everett, Washington, 98201, United States

RECRUITING

Centro de Investigaciones y Proyectos en Neurociencias CIPNA

Barranquilla, 080020, Colombia

RECRUITING

Empresa Social del Estado Hospital Mental de Antioquia Maria Upegui HOMO

Bello, 051053, Colombia

RECRUITING

Centro de Investigaciones del Sistema Nervioso Grupo Cisne Ltda.

Bogotá, 111166, Colombia

COMPLETED

Psynapsis Salud Mental S.A.

Pereira, 660002, Colombia

RECRUITING

Ratandeep Surgical Hospital And Endoscopy Clinic

Ahmedabad, 380008, India

SUSPENDED

Society for Psychiatric Update and Research Shanti Nursing Home

Aurangabad, 431005, India

SUSPENDED

Chopda Medicare & Research Centre

Nashik, 422005, India

SUSPENDED

Deva Institute of Healthcare And Research Pvt Ltd

Varanasi, 221005, India

SUSPENDED

Clinic of Neurology and Psychiatry for Children and Youth

Belgrade, 11000, Serbia

ACTIVE NOT RECRUITING

Institute of Mental Health Serbia

Belgrade, 11000, Serbia

ACTIVE NOT RECRUITING

University Clinical Center NIS

Niš, 18000, Serbia

ACTIVE NOT RECRUITING

Clinical Center of Vojvodina

Novi Sad, 21000, Serbia

SUSPENDED

MeSH Terms

Conditions

Bipolar Disorder

Interventions

lumateperone

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Study Officials

• Intra-Cellular Therapies, Inc. Clinical Trial

  Intra-Cellular Therapies, Inc.

  STUDY DIRECTOR

Central Study Contacts

Study Contact

CONTACT

844-434-4210; Participate-In-This-Study1@its.jnj.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: April 18, 2024
• Study Start: May 14, 2024
• Primary Completion (Estimated): October 31, 2031
• Study Completion (Estimated): October 31, 2031
• Last Updated: July 31, 2026

Record last verified: 2026-07

Locations

CO (4); US (56); IN (4); SE (4)