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

L
Leslie Hulvershorn, MD, MSc

Primary Investigator

Recruiting
10 years - 17 years
All
Phase 3
25 participants needed
1 Location

Brief description of study

This study investigates the safety and tolerability of an investigational medication in young people with schizophrenia or bipolar disorder. 
 
Schizophrenia is a mental disorder that affects how a person thinks, feels, and behaves. 
Bipolar disorder is a condition that causes extreme mood swings, including emotional highs (mania or hypomania) and lows (depression)

Detailed description of study

Participants will go through a screening period of up to 2 weeks to check if they can join the study. For 26 weeks, participants will take the investigational medication once a day. After this, there will be a 2-week follow-up period to check on the participants' safety.

  • Who can participate: Boys and girls aged 13 to 17 years with schizophrenia or aged 10 to 17 years with bipolar I or II disorder can participate. They must have a primary diagnosis confirmed by a specific interview process and be able to provide consent and assent.
  • Study details: Participants will take the investigational medication once daily for 26 weeks, followed by a follow-up visit about 2 weeks after their last dose. The study is open-label, meaning all participants know they are receiving the investigational medication.
  • Study timelines: The study will last 26 weeks.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Schizophrenia, Bipolar I Disorder, Bipolar II Disorder, Riley
  • Age: 10 years - 17 years
  • Gender: All

Inclusion Criteria:

New Patients must meet the following criteria:

  • Able to provide consent as follows:
    • The child's legally authorized representative (eg, parent or guardian) must provide written, informed consent.
    • The child must provide written assent to study enrollment.
  • Male or female children aged 13 to 17 years with schizophrenia or male or female children aged 10 to 17 years with bipolar I or II disorder.
  • The Child has a primary diagnosis of schizophrenia or bipolar I or II disorder.
  • The Child 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 meet all of the following criteria:

  • Must have safely completed the lead-in study.
  • Able to provide consent as follows:
    • The child's legally authorized representative (eg, parent or guardian) must provide written, informed consent.
    • The child must provide written assent to study enrollment.

Exclusion Criteria:

New Patients who meet any of the following exclusion criteria will not be eligible to participate in this study:

  • The Child has a primary psychiatric diagnosis other than schizophrenia or bipolar I or bipolar II disorder. except ADHD and Mild intellectual disability.
  • The Child has > 1 suicidal attempt within the past 2 years or has a current suicidal intent with or without a plan.
  • The Child is considered to be an imminent danger to him/herself or others.

Rollover Patients will directly enroll from the lead-in efficacy study at Day 1 of this long-term safety study. Rollover Patients who meet any of the following exclusion criteria will not be eligible to participate in this study:

  • The Child is unable to comply with study procedures or judged to be inappropriate for the study.
  • The Child has a current suicidal intent with or without a plan.
  • The Child is considered to be an imminent danger to him/herself or others.

Other inclusion and exclusion criteria may apply

Updated on 12 Aug 2025. Study ID: PSYC-ICT-LUMATEPERONE, 21840

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