Autism with Irritability for Teens

Caplyta vs Placebo

Study Specific Details:

Caplyta vs Placebo- This is a double blind study in which subjects are randomly placed on Caplyta vs Placebo. Dr. Handal will be able to find out what medication the subject is on in case of emergency.
This study will concentrate on reducing irritability in adolescents with ASD.
6-week treatment period with weekly visits. Option to enroll in an open-label phase.
Participants are reimbursed $100 for their time at the end of each completed visit.

Adolescents ages 13-17
Subject with a primary DSM-V diagnosis of ASD. Diagnosis confirmed by K-SADS-PL criteria at screening. CGI-S scale will be administered to determine irritability eligibility at screening and baseline.
Ability to tolerate venipuncture procedures for blood sampling.
BMI is greater than the 5th percentile according to age and gender.
Psychotherapy is allowed if stable for at least 90 days prior to screening and consistent throughout the study.
Mild to moderate intellectual disability based on DSM-5 criteria (severe and profound are exclusionary).
ADHD medications are allowed if taken for ADHD and have been stable for at least 30 days prior to screening.

Has a primary psychiatric diagnosis other than ASD with the exception of ADHD.
Fragile-X Syndrome or Rett’s Disorder.
History of seizures, with the exception of febrile seizures.
History of significant head trauma, history of tumor of the CNS, or any other condition that predisposes to seizures.
Significant risk of suicidal behavior during the study, has had 1 or more suicidal attempts within 2 years of screening or is considered to be an imminent danger to him/herself or others.
Has had exposure to Caplyta within 3 months of baseline.
Inability to swallow tablets.
All medications except for ADHD medications, Melatonin, or Diphenhydramine are exclusionary during the study period.

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