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Safety Study of Lumateperone for Schizophrenia, Bipolar Disorder, or Autism Spectrum Disorder in Children and Teens

This study is testing the safety and how well children and teenagers tolerate (handle) a medication called lumateperone. It's for young people aged 5 to 17 who have schizophrenia, bipolar disorder, or autism spectrum disorder. Participants will take lumateperone capsules or orally disintegrating tablets once a day for about 6 months. The main goal is to see how often common side effects happen. This study is currently unclear about its recruitment status and plans to enroll about 300 participants.

Study design
This is an open-label study, meaning everyone knows they are receiving the study drug, and it will include about 300 participants.
What's involved
You would have a screening period of up to 2 weeks, followed by 26 weeks of taking lumateperone daily, and then a 2-week safety follow-up visit.
Compensation
Not stated in the trial record.
Follow-up
Participants will have a safety follow-up visit about 2 weeks after their last dose of the study medication.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06229210

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

Recruiting
PHASE3Ages 5–17InterventionalTreatment
Intra-Cellular Therapies, Inc.
~300 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:Lumateperone

At a glance

Recruiting sites
51 of 64 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Common Adverse Events
Measured over Up to 6 months

Conditions

Schizophrenia
Bipolar Disorder
Autism Spectrum Disorder

Explore related trials

Autism Spectrum DisorderBipolar DisorderSchizophrenia

Where it's being run

64 sites across 21 states
Florida21
California7
Texas6
Georgia5
Serbia4
Ohio3
New York2
Oklahoma2

Study leadership

  • Intra-Cellular Therapies, Inc. Clinical Trial · STUDY_DIRECTOR · Intra-Cellular Therapies, Inc.

Who to contact

Study Contact
[email protected]
844-434-4210
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

Exclusion

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.

What this trial measures

  • Incidence of Common Adverse EventsUp to 6 months

    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.