Pilot Trial of Pregnenolone in Autism

• Status: Recruiting
• Trial end date: 2023-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a research study to examine the tolerability and effectiveness of pregnenolone in individuals with autism. Pregnenolone is a naturally occurring steroid hormone in the brain that has been implicated in treating various psychiatric conditions. The investigators hope to learn the effects and safety of using pregnenolone in reducing irritability and sensitivity to sensory differences and improving social communication in individuals with autism. The investigators hope by studying the effects of pregnenolone in more detail, the investigators can design better ways to treat individuals with autism.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University
• Collaborator: Simons Foundation

Criteria

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.