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

What this study is about

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.

Who can join (things the study team will check)

✅ You may be able to join if…

• 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.

🚫 You may not be able to join if…

• 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

• Southwest Autism Research and Resource Center, Phoenix, Arizona, United States
• Pillar Clinical Research, LLC, Little Rock, Arkansas, United States
• Advanced Research Center, Inc, Anaheim, California, United States
• National Institute Of Clinical Research, Garden Grove, California, United States
• Excell Research Inc, Oceanside, California, United States
• Inland Psychiatric Medical Group Inc, Redlands, California, United States
• University Of California - Davis, Sacramento, California, United States
• University Of California San Diego, San Diego, California, United States
• Next Level Clinical Trials, LLC, West Covina, California, United States
• MCB Clinical Research Centers LLC, Colorado Springs, Colorado, United States
• Royal Palm Clinical Research, Fort Myers, Florida, United States
• Sarkis Clinical Trials, Gainesville, Florida, United States

+ 49 more sites.

Who to contact

ITI Clinical Trials · 646 440-9333 · ITCIClinicalTrials@itci-inc.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06229210.