Pilot Trial of Pregnenolone in Autism

Description

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.

Conditions

Autism Spectrum Disorder, Autism

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Study Overview

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Study Details

Study overview

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.

Randomized Controlled Pilot Trial of Pregnenolone in Autism

Pilot Trial of Pregnenolone in Autism

Condition
Autism Spectrum Disorder
Intervention / Treatment

-

Contacts and Locations

Stanford

Stanford University School of Medicine, Stanford, California, United States, 94305

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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 to 25 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Stanford University,

Antonio Y. Hardan, MD, PRINCIPAL_INVESTIGATOR, Stanford University

Study Record Dates

2025-03