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Natural brain hormone could tame autism irritability

NCT ID NCT02627508

Symptom relief Sponsor: Stanford University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether pregnenolone, a natural hormone in the brain, can help reduce irritability and improve social communication in people with autism. 40 participants aged 14 to 25 took either pregnenolone or a placebo for several weeks. Researchers measured changes in behavior and sensory sensitivity to see if the hormone was safe and effective.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
pregnenolone
What this could lead to
If it works, this could point toward a new way to ease irritability and sensory issues in some people with autism.
What could go wrong
This is a small, early pilot study with only 40 people. Results may not apply to everyone, and the benefits might be small or not happen at all.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

40 people

The number who actually took part.

Started

Jan 2016

Finished

Mar 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

14 to 25 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 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. 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.

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Conditions

The condition(s) this trial relates to.

autism autism spectrum disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Autism Autism spectrum disorder

Contacts and locations

Locations

  • Stanford University School of Medicine

    Stanford, California, 94305, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.