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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;
outpatients between 14 and 25 years of age with a Tanner stage of IV or V
Must not have
pregnant or sexually active female subjects who do not adhere to use an appropriate form of external prophylactics
participants taking steroid medications
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Summary
This trial is testing pregnenolone, a natural hormone in the brain, to see if it can help people with autism. Pregnenolone is part of a neurosteroid pathway that has been studied for its potential therapeutic value in stress and drug abuse-related disorders. The goal is to find out if it can reduce irritability and sensitivity to sensory differences, and improve social communication. Researchers hope this will lead to better treatments for autism.
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.
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.
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 belowSelect...
I am between 14 and 25 years old and have reached a late stage of puberty.
Select...
I am between 14 and 25 years old and have reached a late stage of puberty.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not pregnant or I use birth control if sexually active.
Select...
I am currently taking steroid medications.
Select...
I do not have frequent seizures or severe illness.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Side effects data
From 2011 Phase 4 trial • 80 Patients • NCT014090963%
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
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Autism Spectrum Disorder (ASD) often target neurochemical pathways to alleviate symptoms. Pregnenolone, a naturally occurring steroid hormone, is being studied for its potential to reduce irritability and sensory sensitivity while improving social communication by modulating neurosteroid activity in the brain.
Melatonin, another treatment, helps regulate sleep patterns by influencing the circadian rhythm, which is crucial for improving sleep disturbances common in ASD. Omega-3 fatty acids, although not strongly recommended, are thought to support brain function and reduce inflammation.
These treatments matter for ASD patients as they address core symptoms and improve quality of life by targeting underlying neurobiological mechanisms.
Replication Pilot Trial of Therapeutic Horseback Riding and Cortisol Collection With Children on the Autism Spectrum.Advances in the research of melatonin in autism spectrum disorders: literature review and new perspectives.
Replication Pilot Trial of Therapeutic Horseback Riding and Cortisol Collection With Children on the Autism Spectrum.Advances in the research of melatonin in autism spectrum disorders: literature review and new perspectives.
Find a Location
Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,467 Previous Clinical Trials
17,496,075 Total Patients Enrolled
36 Trials studying Autism Spectrum Disorder
3,797 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
9 Previous Clinical Trials
441 Total Patients Enrolled
8 Trials studying Autism Spectrum Disorder
393 Patients Enrolled for Autism Spectrum Disorder
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not pregnant or I use birth control if sexually active.I am between 14 and 25 years old and have reached a late stage of puberty.I am physically healthy.My medications have not changed in the last 2 weeks.My medications have not changed in the last 2 weeks.I am currently taking steroid medications.OR
Aberrant Behavior Checklist-Irritability (ABC-I)≥ 15 and Clinical Global Impression-Severity subscale (CGI-S) ≥4
The person has a lot of problems with irritability and their Global Impression of Severity is at least a 4 out of 7.You have already tried the medication pregnenolone in the past.You cannot make any changes to your mental health treatment plan during the trial.I do not have frequent seizures or severe illness.I am physically healthy.I am between 14 and 25 years old and have reached a late stage of puberty.You cannot change your current counseling or therapy during the trial.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Pregnenolone (up to 500 mg per day)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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