Pilot Trial of Pregnenolone in Autism

Inclusion Criteria:

   - outpatients between 14 and 25 years of age with a Tanner stage of IV or V;

   - male and female subjects who were physically healthy;

   - diagnosis of ASD based on DSM-5, expert clinical opinion and confirmed with Autism
   Diagnostic Interview - Revised (ADI-R) and either Autism Diagnostic Observation
   Schedule (ADOS) or Childhood Autism Rating Scale (CARS-2);

   - Aberrant Behavior Checklist -Irritability (ABC-I)≥ 18 and Clinical Global Impression
   (CGI)-Severity subscale ≥ 4;

   - stable concomitant medications for at least 2 weeks;

   - no planned changes in psychosocial interventions during the trial.

Exclusion Criteria:

   - Diagnostic and Statistical Manual (DSM-5) diagnosis of schizophrenia, schizoaffective
   disorder, alcohol use disorder;

   - prior adequate trial of pregnenolone;

   - active medical problems: unstable seizures (>2 in past month), significant physical
   illness;

   - pregnant or sexually active female subjects who do not adhere to use an appropriate
   form of external prophylactics;

   - participants taking steroid medications.