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Multicenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder in Pediatric Patients

Studying Lumateperone for irritability in children with autism.

Recruiting
5-17 years
All
Phase 3

This study tests a new medication called **lumateperone** for kids with irritability linked to *Autism Spectrum Disorder* (ASD). ASD is a condition affecting communication and behavior. The study involves three phases: a screening period (up to 14 days), a treatment period (6 weeks), and a safety follow-up (1 week). During the 6-week treatment, kids are randomly given either a high dose, low dose, or no medication (a placebo). A placebo is a pill with no active medicine, used for comparison. The study is double-blind, meaning neither the participants nor the researchers know who is getting which treatment to avoid bias.

Eligible children are aged 13 to 17 and must have ASD with significant irritability. Parents or guardians need to give consent and be involved throughout the study.

  • The study lasts for about 9 weeks total, including all phases.
  • Participants need to visit the clinic multiple times.
  • Participation is key for safety monitoring and effective results.
Study details
    Irritability Associated With Autism Spectrum Disorder

NCT06690398

Intra-Cellular Therapies, Inc.

12 July 2025

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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