Trial Search Results

Pilot Trial of Pregnenolone in Autism

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.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Stanford University

Collaborator: Simons Foundation

Stanford Investigator(s):

Intervention(s):

  • Drug: Pregnenolone
  • Drug: Placebo

Phase:

Phase 2

Eligibility


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 Autism Spectrum Disorder (ASD) based on DSM-5, expert clinical opinion
   and confirmed with Autism Diagnostic Interview - Revised (ADI-R) and Autism Diagnostic
   Observation Schedule (ADOS);

   - 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.

Ages Eligible for Study

14 Years - 25 Years

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Robin Libove
650-736-1235
Recruiting