Autism with Irritability Study for Children and Teens

Rexulti vs Placebo

Study Specific Details:

Rexulti vs Placebo- This is a double blind study in which subjects are randomly placed on Rexulti 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 children and adolescents with ASD.
8-week study with 4 office visits and 1, 3, 4 and 6 being virtual visits. Option to enroll in an open label phase.
Participants are reimbursed $50 for their time and travel at the end of each completed visit.

Children and Adolescents ages 5-17
Subject with a primary DSM-V diagnosis of ASD. Diagnosis confirmed by ADI_R 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.
Psychotherapy is allowed if stable for at least 30 days prior to screening and consistent throughout the study.
Mental age of 2 yrs or older, based on school participation, social history or medical records.
Strattera and stimulants are allowed medications if taken for ADHD and have been stable for at least 30 days prior to screening.

Current
Fragile-X Syndrome or Rett's Disorder.
History of Seizures (except for a single childhood febrile seizure or post-traumatic seizure), or a history of seizure head trauma or stroke, or have a history or current evidence of other unstable medical conditions that would expose them to undue risk of a significant adverse event.
Significant risk of committing violent acts, serious self harm, or suicide based on history,.
Subjects who have been exposed to Rexulti.
Inability to swallow tablets.
Subject weighs less than 33lbs.

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