A Study of Esomeprazole in Children With Autism

This study is looking at how well a medicine called Esomeprazole works for children with Autism Spectrum Disorder (ASD). Esomeprazole is being tested to see if it can help improve social communication difficulties in children. We are looking for 25 children between 2 and 6 years old who have been diagnosed with ASD. The study will measure changes in social responsiveness using a special scale over 8 weeks to see if the medicine is effective. The current status of this study is unclear.

Study design: This is an open-label study, meaning everyone knows what treatment is being given. It plans to include 25 children.
What's involved: Participants will take Esomeprazole daily for 8 weeks. Assessments will be done at the start, at 4 weeks, and at 8 weeks.
Compensation: Not stated in the trial record.
Follow-up: Participants will be followed for 8 weeks, with assessments at 4 and 8 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

A Study of Esomeprazole in Children With Autism

Recruiting

PHASE2Ages 2–6InterventionalTreatment

Stanford University

~25 participants

Updated 2026-06-25 on ClinicalTrials.gov

What's tested:Esomeprazole

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Change from Baseline on the Social Responsiveness Scale, 2nd Edition (SRS-2)

Measured over Baseline, 4 Weeks, 8 Weeks

Conditions

Autism

Autism Spectrum Disorder

NCT03866668

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

Stanford University School of Medicine
Stanford, Californiastudy coordinator listed
Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

Antonio Hardan, MD · PRINCIPAL_INVESTIGATOR · Stanford University

Who to contact

Nina Raman

[email protected]

(650)736-1235

Email the study team

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Eligibility criteria

Inclusion

outpatients 2 to 6 years of age;

males and females who are physically healthy;

diagnosis of autism spectrum disorder based on clinical evaluation and DSM-5 criteria, and confirmed using the Autism Diagnostic Interview-Revised, and the Autism Diagnostic Observation Schedule or Childhood Autism Rating Scale second edition (CARS-2)

care provider who could reliably bring subject to clinic visits, could provide trustworthy ratings, and interacted with subject on a regular basis;

ability of subject to swallow the compound;

stable concomitant medications for at least 2 weeks (4 weeks if patient took fluoxetine);

no planned changes in psychosocial interventions during the open-label trial.

Exclusion

DSM-5 diagnosis of schizophrenia, schizoaffective disorder, or psychotic disorder not otherwise specified;

prior adequate trial of Esomeprazole;

active medical problems such as unstable seizures, or significant physical illness (e.g., serious liver or renal pathology).

What this trial measures

Change from Baseline on the Social Responsiveness Scale, 2nd Edition (SRS-2)Baseline, 4 Weeks, 8 Weeks
Social Responsiveness Scale (SRS) raw scores measure social abilities with lower raw scores meaning better social abilities. (Raw Score Range: 0 - 195)

Trialytics