A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Lumateperone in the Treatment of Irritability Associated With Autism Spectrum Disorder in Pediatric Patients 5 to 17 Years of Age

The primary objective of this study is to evaluate the effectiveness and safety of a study medication compared with placebo in improving irritability in autistic individuals.

Study Length

Approximately 9 weeks

Disorder/Condition

Autism Spectrum Disorder

Inclusion Criteria

  • 13-17 years old
  • Diagnosis of autism spectrum disorder (ASD)

Study Description (brief)

The primary objective of this study is to evaluate the effectiveness and safety of a study medication compared with placebo in improving irritability in autistic individuals.

Study Contact

Lucia Tu at [email protected] or (845) 398-6620.

Exclusion Criteria

  • History or current diagnosis of Rett syndrome or Fragile X syndrome
  • Current use of antipsychotics (e.g., aripiprazole), antidepressants (e.g., fluoxetine), mood stabilizers (e.g., lithium, valproate, carbamazepine), and/or benzodiazepines (e.g., diazepam)

Study Location

Nathan Kline Institute (Orangeburg, NY)
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