← Back to Search

Corticosteroid

Pregnenolone for Autism

Phase 2
Recruiting
Led By Antonio Y. Hardan, MD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
outpatients between 14 and 25 years of age with a Tanner stage of IV or V;
stable concomitant medications for at least 2 weeks
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2-week, 4-week, 6-week, 8-week, 10-week, 14-week
Awards & highlights

Study Summary

This trial is testing whether the hormone pregnenolone is effective and safe for treating symptoms of autism. The goal is to improve social communication and reduce irritability and sensitivity to sensory differences.

Who is the study for?
This trial is for healthy males and females aged 14-25 with Autism Spectrum Disorder (ASD), confirmed by specific diagnostic tools. Participants must have a certain level of irritability and severity of ASD symptoms, be in the late stages of puberty, and on stable medications without changes planned during the study. Those with unstable seizures, significant illness, other major psychiatric disorders, or women who are pregnant or not using contraception cannot join.Check my eligibility
What is being tested?
The study tests pregnenolone's safety and effectiveness compared to a placebo in reducing irritability, improving sensitivity to sensory differences, and enhancing social communication in individuals with autism. Pregnenolone is a hormone thought to help various psychiatric conditions.See study design
What are the potential side effects?
Potential side effects may include hormonal imbalances since pregnenolone is a steroid hormone. Specific side effects aren't listed but could resemble those associated with other steroids such as mood swings, weight gain, or increased susceptibility to infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 14 and 25 years old and have reached a late stage of puberty.
Select...
My medications have not changed in the last 2 weeks.
Select...
I am physically healthy.
Select...
I am between 14 and 25 years old and have reached a late stage of puberty.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2-week, 4-week, 6-week, 8-week, 10-week, 14-week
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2-week, 4-week, 6-week, 8-week, 10-week, 14-week for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline in parent rated Aberrant Behavior Checklist Irritability (ABC-I) score during treatment
Secondary outcome measures
Change from baseline in Clinical Global Impression (CGI) scores during treatment
Change from baseline in Vineland Adaptive Behavior Scales Second Edition (VABS-II)
Electroencephalography
+8 more

Side effects data

From 2011 Phase 4 trial • 80 Patients • NCT01409096
3%
Sinusitis
3%
Corneal ulceration
3%
Skin abscess followed by allergic reaction to antibiotic used to treat it
3%
Skin rash
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Pregnenolone

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Pregnenolone (up to 500 mg per day)Experimental Treatment1 Intervention
Twice daily intake of orally administered Pregnenolone will occur on a schedule as described below. Weeks 1 and 2: 30mg twice daily (total 60mg per day) Weeks 3 and 4: 60mg twice daily (total: 120mg per day) Weeks 5 and 6: 90mg twice daily (total: 180mg per day) Weeks 7 and 8: 150mg twice daily (total: 300mg per day) Weeks 9 and 10: 210mg twice daily (total: 420mg per day) Weeks 11 to 14: 250mg twice daily (total: 500mg per day)
Group II: PlaceboPlacebo Group1 Intervention
Placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pregnenolone
2011
Completed Phase 4
~770

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,379 Previous Clinical Trials
17,333,353 Total Patients Enrolled
32 Trials studying Autism Spectrum Disorder
4,013 Patients Enrolled for Autism Spectrum Disorder
Simons FoundationOTHER
7 Previous Clinical Trials
101,216 Total Patients Enrolled
5 Trials studying Autism Spectrum Disorder
1,191 Patients Enrolled for Autism Spectrum Disorder
Antonio Y. Hardan, MDPrincipal InvestigatorStanford University
8 Previous Clinical Trials
411 Total Patients Enrolled
7 Trials studying Autism Spectrum Disorder
363 Patients Enrolled for Autism Spectrum Disorder

Media Library

Pregnenolone (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT02627508 — Phase 2
Autism Spectrum Disorder Research Study Groups: Pregnenolone (up to 500 mg per day), Placebo
Autism Spectrum Disorder Clinical Trial 2023: Pregnenolone Highlights & Side Effects. Trial Name: NCT02627508 — Phase 2
Pregnenolone (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02627508 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what degree is Pregnenolone hazardous to those receiving it?

"Due to the Phase 2 status of this trial, which signals a lack of efficacy data but some safety information, our team has assigned Pregnenolone a score of 2."

Answered by AI

Are there still vacancies available in this research project?

"Affirmative. Clinicaltrials.gov provides evidence that this medical trial is recruiting patients, having been first published on January 29th 2016 and updated February 15 2022. 40 participants are needed at a single medical facility to complete the study."

Answered by AI

Does this medical trial permit participation from individuals younger than 55?

"To qualify for the research, patients must be between 14 and 25 years old. There are 235 studies dedicated to those under 18 and 51 devoted to elderly individuals above 65."

Answered by AI

What is the upper boundary of participants in this experiment?

"Affirmative. Clinicaltrials.gov confirms that this research project, which was initially posted on January 29th 2016, is actively recruiting participants. The investigators are seeking 40 volunteers from a solitary medical site."

Answered by AI

Is Pregnenolone being studied in any other research projects?

"At present, 6 clinical trials are underway to explore the efficacy of Pregnenolone. Unfortunately, none have reached Phase 3 yet. Nevertheless, there are 7 sites across Dallas, Texas that are conducting experiments with this medication."

Answered by AI

What are the eligibility criteria for enrolling in this research?

"This trial is recruiting 40 adolescents and young adults with autism, between the ages of 14-25. To qualify, participants must have been taking stable medications for at least two weeks; display male/female physical health; demonstrate a Tanner stage IV or V level maturity; present an Aberrant Behavior Checklist Irritability score of 18+ and Clinical Global Impression Severity subscale ≥ 4; and not plan to alter any psychosocial interventions during study duration."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
< 18
18 - 65
What site did they apply to?
Stanford University School of Medicine
What portion of applicants met pre-screening criteria?
Met criteria
~4 spots leftby Mar 2025