Autism Study for Adolescents Struggling with Social and Communication Skills

Investigational Medication vs Placebo

Study Specific Details:

Investigation Medication vs Placebo- This is a double blind study in which subjects are randomly place on investigational medication or Placebo. Dr. Handal will be able to find out what medication the subject is on in case of emergency.
10 visits over a 6 month period.
Participants are reimbursed $50 for their time and travel at the end of each completed visit.

Male or Female ages 12 to 17.
BMI 18-34, inclusive
Subjects have a diagnosis of Autism Spectrum Disorder. Diagnosis confirmed by ADOS-2 criteria at screening. An ADOS-2 or ADIR that has been completed w/in the past 3 years is acceptable if item responses are available for entry.
IQ composite score of 70 or above, will be confirmed using the WASI scale or if conducted within the past 3 years if adolescent or 5 years if adult is also acceptable.
Patient has a designated care/study partner.
Ability to tolerate venipuncture procedures for blood sampling.
ABA psychotherapy and occupational therapy are allowed, but must be stable for at least 4 weeks prior to screening.
Must be able to swallow tablet whole with aid of water.
Does not need to fast prior to screening.

IQ less than 70.
Diagnosis or clinical history of bipolar disorder, schizophrenia, or other medical or psychiatric condition which, in the opinion of the Investigator or Medical Monitor, would place the subject at an increased risk of safety/tolerability issues.
Patient has Rett syndrome or Child Disintegrative Disorder.
History of epilepsy without current adequate control, or any seizure in the 6 mo. proceeding screening.
Has a diagnosis of, or clinical history indicative migraines with or without aura, including basilar and/or hemiplegic migraine.
History of suicidal ideation or behavior in the past 12 months.
History of alcohol use or substance use disorder within the past 12 months of screening or positive for drugs at screening unless consistent with current prescription for medical condition.
Has ever tested positive of hepatitis B, C, or HIV.
Excluded medications: SSRIs, SNRIs, TCAs, MAO-A inhibitors, risperdal, abilify, St. John's wort
Has participated an any other study in the past 60 days prior to screening.

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