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.
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).
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;
Single group
Lumateperone
DrugLumateperone 5 mg - 42 mg capsules or orally disintegrating tablets administered orally, once daily based on age and indication
Incidence of Common Adverse Events
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.
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