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Brain chemical targeted to ease autism social struggles

NCT ID NCT05063656

Symptom relief Sponsor: David Cochran 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether gabapentin, a medication that boosts a calming brain chemical called GABA, could improve social thinking in teens with autism. Sixteen adolescents aged 13-17 took gabapentin for 8 weeks while researchers measured brain GABA levels and social abilities. The goal was to see if correcting a brain chemical imbalance could ease social difficulties.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

16 people

The number who actually took part.

Started

Feb 2022

Finished

Dec 2025

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

13 to 17 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: * Age 13-17 years * English as primary language (both child and legal guardian) * DSM-5 criteria for Autism Spectrum Disorder * IQ \>70 per Weschler Abbreviated Scale of Intelligence (WASI) * Informed assent for the study (The guardian must also give written informed consent) * For sexually active females, agreement to use two forms of contraception during trial to avoid pregnancy Exclusion Criteria: * Any neurological disorder (e.g., cerebral palsy, fetal alcohol syndrome, cerebral neoplasm, bacterial meningitis, epilepsy, etc.) * Genetic disorders (e.g., Fragile X, Rett Syndrome, etc.) * Contraindications for MRI, such as metallic or electronic implants in the body, or severe claustrophobia * Unstable psychiatric disorder expected to require psychotropic medication changes over the course of the study * History of psychotic disorder * Any condition that would prevent the subject from being able to complete study protocol * Unstable medical illness such as diabetes, asthma, thyroid disease * Currently on medications that cause respiratory depression, e.g. opioids, benzodiazepines * Clinically significant suicidal ideation as assessed by the Columbia Suicide Severity Rating Scale * History of intolerance to gabapentin or pregabalin * Current substance use (including nicotine) * Current treatment with gabapentin * History of renal dysfunction * Pregnancy in female participants.

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Conditions

The condition(s) this trial relates to.

autism spectrum disorder

As listed by the trial registrant

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

Autism spectrum disorder

Contacts and locations

Locations

  • University of Massachusetts Medical School

    Worcester, Massachusetts, 01655, United States

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