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

Recruiting now · Phase 3

Conditions studied: Schizophrenia, Bipolar Disorder, Autism Spectrum Disorder

In brief

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.

Key facts

Study ID

NCT06229210

Run by

Intra-Cellular Therapies, Inc.

People needed

300

Starts

2024-01-25

Expected to finish

2032-04-28

Last updated by the study team

2026-07-31

Who can join

Age: 5 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

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.
• 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.

Where it is running

• Health Synergy Clinical Research — West Palm Beach, Florida, United States (enrolling)
• CenExeli Research LLC — Atlanta, Georgia, United States (enrolling)
• Riveldi Biomedical Research — Miami Lakes, Florida, United States (enrolling)
• University of South Florida Rothman Center of Neuropsychiatry — St. Petersburg, Florida, United States (enrolling)
• Inland Psychiatric Medical Group Inc — Redlands, California, United States (enrolling)
• Advanced Research Center, Inc — Anaheim, California, United States (enrolling)
• National Institute Of Clinical Research — Garden Grove, California, United States (enrolling)
• Pillar Clinical Research, LLC — Little Rock, Arkansas, United States (enrolling)
• Clinical Research Center of Florida — Pompano Beach, Florida, United States (enrolling)
• Southwest Autism Research and Resource Center — Phoenix, Arizona, United States (enrolling)
• Sarkis Clinical Trials — Gainesville, Florida, United States (enrolling)
• United Research Institute — Hialeah, Florida, United States (enrolling)
• Advanced Research Institute of Miami — Homestead, Florida, United States (enrolling)
• University Of California - Davis — Sacramento, California, United States (enrolling)
• Columbus Clinical Services LLC — Miami, Florida, United States (enrolling)
• Care Research Center Inc — Miami, Florida, United States (enrolling)
• Blue Medical Research — Miami, Florida, United States (enrolling)
• Next Level Clinical Trials, LLC — West Covina, California, United States (enrolling)
• Envision Trials LLC — Miami, Florida, United States (enrolling)
• Excell Research Inc — Oceanside, California, United States (enrolling)
• Diverse Clinical Research LLC — Miami, Florida, United States (enrolling)
• Links Clinical Trials — Miami, Florida, United States (enrolling)
• New Med Research Inc — Miami Gardens, Florida, United States (enrolling)
• The Angel Medical Research Corporation — Miami Gardens, Florida, United States (enrolling)
• Atlanta Center for Medical Research — Atlanta, Georgia, United States (enrolling)

Full record on ClinicalTrials.gov

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