NCT06229210From ClinicalTrials.govRecruiting

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

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

Schizophrenia
Bipolar Disorder
Autism Spectrum Disorder

At a glance

Phase: Phase 3
Study type: Interventional
Sponsor: Intra-Cellular Therapies, Inc.
Enrolment target: 300
Started: 25 January 2024
Main results due: 28 April 2032
Study sites: 65
Registry updated: 25 September 2026

Can you take part?

Ages 5 years to 17 years.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria

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.

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(65)

Southwest Autism Research and Resource Center
Phoenix, Arizona, United States
Recruiting
Pillar Clinical Research, LLC
Little Rock, Arkansas, United States
Recruiting
Advanced Research Center, Inc
Anaheim, California, United States
Recruiting
National Institute Of Clinical Research
Garden Grove, California, United States
Recruiting
Excell Research Inc
Oceanside, California, United States
Recruiting
Inland Psychiatric Medical Group Inc
Redlands, California, United States
Recruiting
University Of California - Davis
Sacramento, California, United States
Recruiting
University Of California San Diego
San Diego, California, United States
Completed
Next Level Clinical Trials, LLC
West Covina, California, United States
Recruiting
MCB Clinical Research Centers LLC
Colorado Springs, Colorado, United States
Completed
Royal Palm Clinical Research
Fort Myers, Florida, United States
Suspended
Sarkis Clinical Trials
Gainesville, Florida, United States
Recruiting
United Research Institute
Hialeah, Florida, United States
Recruiting
Advanced Research Institute of Miami
Homestead, Florida, United States
Recruiting
Green Leaf Clinical Trials
Jacksonville, Florida, United States
Recruiting
Vital Care Research
Miami, Florida, United States
Suspended
Columbus Clinical Services LLC
Miami, Florida, United States
Recruiting
Care Research Center Inc
Miami, Florida, United States
Recruiting
Blue Medical Research
Miami, Florida, United States
Recruiting
AP Medical Research
Miami, Florida, United States
Suspended
Envision Trials LLC
Miami, Florida, United States
Recruiting
GTL Medical and Research Group
Miami, Florida, United States
Completed
Diverse Clinical Research LLC
Miami, Florida, United States
Recruiting
Links Clinical Trials
Miami, Florida, United States
Recruiting
New Med Research Inc
Miami Gardens, Florida, United States
Recruiting
The Angel Medical Research Corporation
Miami Gardens, Florida, United States
Recruiting
Riveldi Biomedical Research
Miami Lakes, Florida, United States
Recruiting
APG Research LLC
Orlando, Florida, United States
Suspended
Clinical Research Center of Florida
Pompano Beach, Florida, United States
Recruiting
University of South Florida Rothman Center of Neuropsychiatry
St. Petersburg, Florida, United States
Recruiting
Health Synergy Clinical Research
West Palm Beach, Florida, United States
Recruiting
CenExeli Research LLC
Atlanta, Georgia, United States
Recruiting
Atlanta Center for Medical Research
Atlanta, Georgia, United States
Recruiting
Atlanta Behavioral Research, LLC
Atlanta, Georgia, United States
Completed
Salveo Integrative Health Inc
Lawrenceville, Georgia, United States
Completed
CenExeli Research LLC 1
Savannah, Georgia, United States
Recruiting
Baber Research Group
Naperville, Illinois, United States
Recruiting
Riley Hospital for Children at Indiana University Health
Indianapolis, Indiana, United States
Completed
Neurobehavioral Medicine Group
Bloomfield Hills, Michigan, United States
Recruiting
Midwest Research Group 1
Saint Charles, Missouri, United States
Recruiting
Alivation Research LLC
Lincoln, Nebraska, United States
Recruiting
Clinical Research of Southern Nevada, LLC
Las Vegas, Nevada, United States
Recruiting
NYU Child Study Center
New York, New York, United States
Recruiting
Richmond Behavioral Associates
Staten Island, New York, United States
Recruiting
Quest Therapeutics of Avon Lake
Avon Lake, Ohio, United States
Completed
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
Recruiting
Charak Center for Health and Wellness
Garfield Heights, Ohio, United States
Recruiting
Cutting Edge Research Group
Oklahoma City, Oklahoma, United States
Completed
Sooner Clinical Research
Oklahoma City, Oklahoma, United States
Recruiting
Access Clinical Trials
Nashville, Tennessee, United States
Recruiting
Texas Research Group
Coppell, Texas, United States
Recruiting
PsyMed Solutions
Fort Worth, Texas, United States
Recruiting
Kaleidoscope Clinical Research
Houston, Texas, United States
Recruiting
Red Oak Psychiatry Associates
Houston, Texas, United States
Recruiting
AIM Trials
Plano, Texas, United States
Recruiting
Perceptive Pharma Research
Richmond, Texas, United States
Recruiting
Virginia Commonwealth University
Richmond, Virginia, United States
Recruiting
Northwest Clinical Research Center
Bellevue, Washington, United States
Recruiting
Core Clinical Research
Everett, Washington, United States
Recruiting
Centro de Investigaciones y Proyectos en Neurociencias CIPNA
Barranquilla, Colombia
Recruiting

Showing 60 of 65 sites — filter to narrow it down. 52 of the 65 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT06229210. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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