RecruitingPhase 3

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
5 Years to 17 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This 26-week study tests how safe lumateperone is and how well children and teens can tolerate it. It is for young people with schizophrenia, bipolar disorder, or autism. Everyone in the study knows which medicine they receive.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • A parent or legal guardian must give written permission, and the child or teen must agree in writing.
  • Must be ages 13–17 with schizophrenia, ages 10–17 with bipolar I or II disorder, or ages 5–17 with autism.
  • The main diagnosis must be confirmed using the study's mental health rules and interview.
  • Must receive care without staying in a hospital and be expected to continue this way during the study.
  • If joining from the earlier study, the study doctor must decide that the patient safely finished it.

Who can't join

  • A main mental health diagnosis other than schizophrenia, bipolar I or II disorder, or autism.
  • Schizophrenia with catatonia, which can affect movement and response to others.
  • Bipolar disorder with psychotic features, such as seeing or hearing things that are not there.
  • ADHD is allowed, but any stimulant medicines for it must be unchanged for 30 days before screening and should stay unchanged during the study.
  • For patients with autism, severe or very severe limits in learning and daily living skills are not allowed. Mild or moderate limits may be allowed by the study doctor.
  • The study doctor finds a serious risk of suicidal behavior, or an immediate danger to the patient or others.
  • Certain suicidal thoughts on study checks within 6 months before screening or between screening and the starting visit, or any suicide attempt within 2 years before screening.
  • For patients with bipolar disorder, a score above 3 on the depression test's suicidal-thoughts question at screening or the starting visit.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (59)

AR

AZ

CA

CO

FL

GA

IL

IN

MI

MO

NE

NV

NY

OH

OK

TN

TX

VA

WA