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RECRUITING

NCT06372964

PHASE3

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

Sponsor: Intra-Cellular Therapies, Inc.

View on ClinicalTrials.gov

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).

Official title: 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

Key Details

Gender

All

Age Range

10 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

384

Start Date

2024-05-14

Completion Date

2031-10-31

Last Updated

2026-07-07

Healthy Volunteers

Conditions

Bipolar Depression

Interventions

DRUG

Lumateperone

Lumateperone administered orally, once daily.

DRUG

Placebo

Matching placebo administered orally, once daily.

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.

Locations (68)

Harmonex Neuroscience Research

Dothan, Alabama, United States

Pillar Clinical Research, LLC

Little Rock, Arkansas, United States

Advanced Research Center, Inc

Anaheim, California, United States

Inland Psychiatric Medical Group Inc

Redlands, California, United States

UC Davis Health System

Sacramento, California, United States

University of California San Diego Medical Center

San Diego, California, United States

Next Level Clinical Trials, LLC

West Covina, California, United States

MCB Clinical Research Centers LLC

Colorado Springs, Colorado, United States

Royal Palm Clinical Research

Fort Myers, Florida, United States

United Research Institute

Hialeah, Florida, United States

Advanced Research Institute of Miami

Homestead, Florida, United States

Vital Care Research

Miami, Florida, United States

Columbus Clinical Services LLC

Miami, Florida, United States

Care Research Center Inc

Miami, Florida, United States

HealthMed Clinical Center Inc

Miami, Florida, United States

Ocean Blue Medical Research Center Inc.

Miami, Florida, United States

AP Medical Research

Miami, Florida, United States

Envision Trials LLC

Miami, Florida, United States

GTL Medical and Research Group

Miami, Florida, United States

Links Clinical Trials

Miami, Florida, United States

SouthGen Clinical Research LLC

Miami, Florida, United States

New Med Research Inc

Miami Gardens, Florida, United States

The Angel Medical Research Corporation

Miami Gardens, Florida, United States

Riveldi Biomedical Research

Miami Lakes, Florida, United States

APG Research LLC

Orlando, Florida, United States

Health Synergy Clinical Research

West Palm Beach, Florida, United States

CenExeli Research LLC

Atlanta, Georgia, United States

Advanced Discovery Research

Atlanta, Georgia, United States

Salveo Integrative Health Inc

Lawrenceville, Georgia, United States

CenExeli Research LLC 1

Savannah, Georgia, United States

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

Chicago, Illinois, United States

Revive Research Institute

Elgin, Illinois, United States

Indiana University

Indianapolis, Indiana, United States

MTP Psychiatry LLC

Baltimore, Maryland, United States

Neurobehavioral Medicine Group

Bloomfield Hills, Michigan, United States

Midwest Research Group

Saint Charles, Missouri, United States

Washington University School of Medicine Child and Adolescent Psychiatry Clinic

St Louis, Missouri, United States

Alivation Research LLC

Lincoln, Nebraska, United States

NYU Child Study Center

New York, New York, United States

Haidar Almhana Nieding

Avon Lake, Ohio, United States

University of Cincinnati Medical Center

Cincinnati, Ohio, United States

Charak Center for Health and Wellness

Garfield Heights, Ohio, United States

Westlake America Clinic

Westlake, Ohio, United States

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

Oklahoma City, Oklahoma, United States

Cutting Edge Research Group

Oklahoma City, Oklahoma, United States

Sooner Clinical Research

Oklahoma City, Oklahoma, United States

The University of Texas at Austin

Austin, Texas, United States

BioBehavioral Research of Austin PC

Austin, Texas, United States

REX Clinical Trials LLC

Beaumont, Texas, United States

North Pointe Psychiatry

Flower Mound, Texas, United States

Kaleidoscope Clinical Research

Houston, Texas, United States

Red Oak Psychiatry Associates

Houston, Texas, United States

Perceptive Pharma Research

Richmond, Texas, United States

Virginia Commonwealth University

Richmond, Virginia, United States

Northwest Clinical Research Center

Bellevue, Washington, United States

Core Clinical Research

Everett, Washington, United States

Centro de Investigaciones y Proyectos en Neurociencias CIPNA

Barranquilla, Colombia

Empresa Social del Estado Hospital Mental de Antioquia Maria Upegui HOMO

Bello, Colombia

Centro de Investigaciones del Sistema Nervioso Grupo Cisne Ltda.

Bogotá, Colombia

Psynapsis Salud Mental S.A.

Pereira, Colombia

Ratandeep Surgical Hospital And Endoscopy Clinic

Ahmedabad, India

Society for Psychiatric Update and Research Shanti Nursing Home

Aurangabad, India

Chopda Medicare & Research Centre

Nashik, India

Deva Institute of Healthcare And Research Pvt Ltd

Varanasi, India

Clinic of Neurology and Psychiatry for Children and Youth

Belgrade, Serbia

Institute of Mental Health Serbia

Belgrade, Serbia

University Clinical Center NIS

Niš, Serbia

Clinical Center of Vojvodina

Novi Sad, Serbia

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (68)