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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.

15 December 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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