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

NCT06229210 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: ITI-007-321
• Study Type: interventional
• Target: 300
• Locations: 2 countries
• Sites: 61

Brief 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.

Conditions

Schizophrenia; Bipolar Disorder; Autism Spectrum Disorder

Keywords

Pediatric

Outcome Measures

Primary Outcomes (1)

• Incidence of Common Adverse Events

  An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

  Up to 6 months

Study Arms (1)

Lumateperone

EXPERIMENTAL

Drug: Lumateperone

Interventions

Lumateperone DRUG

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

Lumateperone

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Intra-Cellular Therapies, Inc.: lead

Study Sites (61)

Southwest Autism Research and Resource Center

Phoenix, Arizona, 85006, United States

RECRUITING

Pillar Clinical Research, LLC

Little Rock, Arkansas, 72204, United States

RECRUITING

Advanced Research Center, Inc

Anaheim, California, 92805, United States

RECRUITING

National Institute Of Clinical Research

Garden Grove, California, 92844, United States

RECRUITING

Excell Research Inc

Oceanside, California, 92056, United States

RECRUITING

Inland Psychiatric Medical Group Inc

Redlands, California, 92373, United States

RECRUITING

University Of California - Davis

Sacramento, California, 95817, United States

RECRUITING

University Of California San Diego

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

Sarkis Clinical Trials

Gainesville, Florida, 32607, United States

RECRUITING

United Research Institute

Hialeah, Florida, 33012, United States

RECRUITING

Advanced Research Institute of Miami

Homestead, Florida, 33033, United States

RECRUITING

Vital Care Research

Miami, Florida, 33122, United States

SUSPENDED

Columbus Clinical Services LLC

Miami, Florida, 33125, United States

RECRUITING

Care Research Center Inc

Miami, Florida, 33130, United States

RECRUITING

Blue Medical Research

Miami, Florida, 33144, United States

RECRUITING

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

Diverse Clinical Research LLC

Miami, Florida, 33175, United States

RECRUITING

Links Clinical Trials

Miami, Florida, 33176, United States

RECRUITING

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

SUSPENDED

Clinical Research Center of Florida

Pompano Beach, Florida, 33060, United States

RECRUITING

University of South Florida Rothman Center of Neuropsychiatry

St. Petersburg, Florida, 33701, United States

RECRUITING

Health Synergy Clinical Research

West Palm Beach, Florida, 33407, United States

RECRUITING

CenExeli Research LLC

Atlanta, Georgia, 30030, United States

RECRUITING

Atlanta Center for Medical Research

Atlanta, Georgia, 30331, United States

RECRUITING

Atlanta Behavioral Research, LLC

Atlanta, Georgia, 30338, United States

COMPLETED

Salveo Integrative Health Inc

Lawrenceville, Georgia, 30046, United States

COMPLETED

CenExeli Research LLC 1

Savannah, Georgia, 31405, United States

RECRUITING

Baber Research Group

Naperville, Illinois, 60563, United States

RECRUITING

Riley Hospital for Children at Indiana University Health

Indianapolis, Indiana, 46202, United States

RECRUITING

Neurobehavioral Medicine Group

Bloomfield Hills, Michigan, 48302, United States

RECRUITING

Midwest Research Group 1

Saint Charles, Missouri, 63304, United States

RECRUITING

Alivation Research LLC

Lincoln, Nebraska, 68526, United States

RECRUITING

Clinical Research of Southern Nevada, LLC

Las Vegas, Nevada, 89128, United States

RECRUITING

Richmond Behavioral Associates

Staten Island, New York, 10314, United States

RECRUITING

Quest Therapeutics of Avon Lake

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

Cutting Edge Research Group

Oklahoma City, Oklahoma, 73116, United States

COMPLETED

Sooner Clinical Research

Oklahoma City, Oklahoma, 73116, United States

RECRUITING

Access Clinical Trials

Nashville, Tennessee, 37203, United States

RECRUITING

Texas Research Group

Coppell, Texas, 75019, United States

RECRUITING

PsyMed Solutions

Fort Worth, Texas, 76132, United States

RECRUITING

Kaleidoscope Clinical Research

Houston, Texas, 77089, United States

RECRUITING

Red Oak Psychiatry Associates

Houston, Texas, 77090, United States

RECRUITING

AIM Trials

Plano, Texas, 75093, 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

Clinic of Neurology and Psychiatry for Children and Youth

Belgrade, 11000, Serbia

RECRUITING

Institute of Mental Health Serbia

Belgrade, 11000, Serbia

RECRUITING

University Clinical Center NIS

Niš, 18000, Serbia

RECRUITING

Clinical Center of Vojvodina

Novi Sad, 21000, Serbia

SUSPENDED

MeSH Terms

Conditions

Schizophrenia; Bipolar Disorder; Autism Spectrum Disorder

Interventions

lumateperone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Bipolar and Related Disorders; Mood Disorders; Child Development Disorders, Pervasive; Neurodevelopmental Disorders

Central Study Contacts

ITI Clinical Trials

CONTACT

646 440-9333; ITCIClinicalTrials@itci-inc.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2024
• First Posted: January 29, 2024
• Study Start: January 25, 2024
• Primary Completion (Estimated): April 28, 2032
• Study Completion (Estimated): April 28, 2032
• Last Updated: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (57); SE (4)