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RECRUITING

NCT06229210

PHASE3

Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum Disorder

Sponsor: Intra-Cellular Therapies, Inc.

View on ClinicalTrials.gov

Summary

This is a multicenter, global, 26-week, open-label study to assess the safety and tolerability of lumateperone in pediatric patients with schizophrenia, bipolar disorder or autism spectrum disorder.

Official title: An Open-label, Multicenter Trial to Assess the Safety and Tolerability of Lumateperone in the Treatment of Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum Disorder

Key Details

Gender

All

Age Range

5 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2024-01-25

Completion Date

2032-04-28

Last Updated

2026-07-07

Healthy Volunteers

Conditions

Schizophrenia Bipolar Disorder Autism Spectrum Disorder

Interventions

DRUG

Lumateperone

Lumateperone 5 mg - 42 mg capsules or orally disintegrating tablets administered orally, once daily based on age and indication

Inclusion Criteria: * Able to provide consent as follows: * The patient's legally authorized representative (LAR) (eg, parent or guardian) must provide written, informed consent; * The patient must provide written assent to study enrollment; * Male or female patients aged 13 to 17 years (inclusive) with schizophrenia; male or female patients aged 10 to 17 years (inclusive) with bipolar I or II disorder; or male or female patients aged 5 to 17 years (inclusive) with autism spectrum disorder; * Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM-5-TR) primary diagnosis of schizophrenia, bipolar I or II disorder, or autism spectrum disorder as confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL). * Is currently an outpatient and is anticipated to maintain outpatient status for the duration of the study. Rollover Patients entering from the lead-in study must have safely completed the lead-in study, in the opinion of the Investigator. Exclusion Criteria: * Has a primary psychiatric diagnosis other than schizophrenia, bipolar I or bipolar II disorder or autism spectrum disorder. Schizophrenia with catatonia, or bipolar disorder with psychotic features are not allowed. Exceptions include: * ADHD: If a subject is taking psychostimulant(s) for ADHD, they must have been on a stable treatment regimen of these medication(s) for 30 days prior to Screening. The treatment regimen should remain stable throughout the study. This must be confirmed by the Investigator and noted in the source records. * For ASD patients only, based on Investigator opinion and DSM-5 criteria, mild or moderate intellectual disability is allowed. Severe or profound intellectual disability is exclusionary. * In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during their 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) of the CDRS-R (for bipolar disorder patients only); or * The patient is considered to be an imminent danger to him/herself or others.

Locations (61)

Southwest Autism Research and Resource Center

Phoenix, Arizona, United States

Pillar Clinical Research, LLC

Little Rock, Arkansas, United States

Advanced Research Center, Inc

Anaheim, California, United States

National Institute Of Clinical Research

Garden Grove, California, United States

Excell Research Inc

Oceanside, California, United States

Inland Psychiatric Medical Group Inc

Redlands, California, United States

University Of California - Davis

Sacramento, California, United States

University Of California San Diego

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

Sarkis Clinical Trials

Gainesville, 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

Blue Medical Research

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

Diverse Clinical Research LLC

Miami, Florida, United States

Links Clinical Trials

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

Clinical Research Center of Florida

Pompano Beach, Florida, United States

University of South Florida Rothman Center of Neuropsychiatry

St. Petersburg, Florida, United States

Health Synergy Clinical Research

West Palm Beach, Florida, United States

CenExeli Research LLC

Atlanta, Georgia, United States

Atlanta Center for Medical Research

Atlanta, Georgia, United States

Atlanta Behavioral Research, LLC

Atlanta, Georgia, United States

Salveo Integrative Health Inc

Lawrenceville, Georgia, United States

CenExeli Research LLC 1

Savannah, Georgia, United States

Baber Research Group

Naperville, Illinois, United States

Riley Hospital for Children at Indiana University Health

Indianapolis, Indiana, United States

Neurobehavioral Medicine Group

Bloomfield Hills, Michigan, United States

Midwest Research Group 1

Saint Charles, Missouri, United States

Alivation Research LLC

Lincoln, Nebraska, United States

Clinical Research of Southern Nevada, LLC

Las Vegas, Nevada, United States

Richmond Behavioral Associates

Staten Island, New York, United States

Quest Therapeutics of Avon Lake

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

Cutting Edge Research Group

Oklahoma City, Oklahoma, United States

Sooner Clinical Research

Oklahoma City, Oklahoma, United States

Access Clinical Trials

Nashville, Tennessee, United States

Texas Research Group

Coppell, Texas, United States

PsyMed Solutions

Fort Worth, Texas, United States

Kaleidoscope Clinical Research

Houston, Texas, United States

Red Oak Psychiatry Associates

Houston, Texas, United States

AIM Trials

Plano, 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

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

Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum Disorder

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (61)