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Assessing the safety of lumateperone in young patients with schizophrenia or bipolar 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

Phase 3 Interventional Intra-Cellular Therapies, Inc. · NCT06229210

This study is testing if lumateperone is safe for young people with schizophrenia or bipolar disorder who will take the medication daily for 26 weeks.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment500 (estimated)
Ages5 Years to 17 Years
SexAll
SponsorIntra-Cellular Therapies, Inc. Industry-sponsored
Locations50 sites (Phoenix, Arizona and 49 other locations)
Trial IDNCT06229210 on ClinicalTrials.gov

What this trial studies

This multicenter, global trial evaluates the safety and tolerability of lumateperone in pediatric patients diagnosed with schizophrenia or bipolar disorder. The study includes a 26-week open-label treatment period where participants will receive lumateperone daily, following a screening phase to determine eligibility. Patients will be monitored for safety and tolerability, with a follow-up period to assess any adverse effects after treatment. The trial aims to gather important data on the use of lumateperone in younger populations.

Who should consider this trial

Good fit: Ideal candidates are male or female patients aged 10 to 17 years with a diagnosis of bipolar disorder or aged 13 to 17 years with schizophrenia.

Not a fit: Patients who are not currently outpatients or those who do not meet the diagnostic criteria for schizophrenia or bipolar disorder will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for pediatric patients suffering from schizophrenia or bipolar disorder.

How similar studies have performed: Other studies have shown promise in using lumateperone for treating psychiatric conditions, indicating potential for success in this pediatric population.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Phoenix, Arizona and 49 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions SchizophreniaBipolar DisorderAutism Spectrum DisorderPediatric
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.