Pilot Trial of Pregnenolone in Autism



Status:Recruiting
Conditions:Neurology, Neurology, Psychiatric, Psychiatric, Autism, Autism
Therapuetic Areas:Neurology, Psychiatry / Psychology
Healthy:No
Age Range:14 - 25
Updated:5/23/2018
Start Date:January 29, 2016
End Date:December 2019
Contact:Jaelyn Edwards
Email:jedwrds@stanford.edu
Phone:(650) 736-1235

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Trial Summary
Trial Overview
Inclusion Criteria

Randomized Controlled 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.


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.
We found this trial at
1
site
Stanford University School of Medicine
291 Campus Dr
Stanford, California 94305
(650) 725-3900
Principal Investigator: Antonio Y. Hardan, MD
Phone: 650-736-1235
Stanford University School of Medicine Vast in both its physical scale and its impact on...
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