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

Launched by INTRA-CELLULAR THERAPIES, INC. · Jan 19, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the safety and tolerability of a medication called lumateperone in young patients with schizophrenia or bipolar disorder. The trial is open to both boys and girls aged 10 to 17 and will last for 26 weeks. To participate, patients must have a confirmed diagnosis of schizophrenia or bipolar disorder and be able to provide consent with the help of a parent or guardian. The study is currently looking for new participants, as well as those who have previously taken part in a related study.

During the trial, participants will receive the medication and will be monitored closely to see how well they tolerate it and any side effects that may occur. It’s important to note that individuals who are at high risk for suicidal behavior or have other significant health issues may not be eligible to join. This trial aims to better understand how lumateperone works in young people, which could help improve treatment options for these mental health conditions.

Gender

ALL

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.