Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia, Bipolar D… (NCT06229210) | Clinical Trial Compass
RecruitingPhase 3
Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum Disorder
United States500 participantsStarted 2024-01-25
Plain-language summary
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 participate
Age range5 Years – 17 Years
SexALL
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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…