NCT02627508CompletedPhase 2
Pilot Trial of Pregnenolone in Autism
Randomized Controlled Pilot Trial of Pregnenolone in Autism
Source: ClinicalTrials.gov · Last updated 30 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (actual)
- First submitted
- 2 Dec 2015
- Start date
- 29 Jan 2016
- Primary completion date
- 13 Mar 2026
- Lead sponsor
- Stanford University
- Diseases
- Autism
- NCT number
- NCT02627508
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 40
- From 29 Jan 2016 to the primary completion date, 13 Mar 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- prior adequate trial of pregnenolone;
- participants taking steroid medications.
Other illness
- Diagnostic and Statistical Manual (DSM-5) diagnosis of schizophrenia, schizoaffective disorder, alcohol use disorder;
- active medical problems: unstable seizures (\>2 in past month), significant physical illness;
Other
- pregnant or sexually active female subjects who do not adhere to use an appropriate form of external prophylactics;
Who the study is looking for
- 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 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.
Age in the registry: 14 years to 25 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Stanford University School of Medicine Coordinator of this site? Confirm its status | Stanford | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.