Actively Recruiting
A Study of Esomeprazole in Children With Autism
Led by Stanford University · Updated on 2025-11-12
25
Participants Needed
1
Research Sites
496 weeks
Total Duration
On this page
Sponsors
S
Stanford University
Lead Sponsor
S
SPARK (Stanford University)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Autism is a pervasive developmental disorder characterized by core deficits in social behavior and communication and the presence of repetitive/stereotyped behaviors. The objective of the study is to evaluate the efficacy of Esomeprazole as a treatment for social communication deficits in children with Autism Spectrum Disorder (ASD). This prospective 12 week open-label study will invite 25 children with ASD between the ages of 2 and 6 years of age to participate.
CONDITIONS
Official Title
A Study of Esomeprazole in Children With Autism
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Outpatients aged 2 to 6 years
- Males and females who are physically healthy
- Diagnosis of autism spectrum disorder based on clinical evaluation and DSM-5 criteria, confirmed by Autism Diagnostic Interview-Revised and either Autism Diagnostic Observation Schedule or Childhood Autism Rating Scale second edition (CARS-2)
- Care provider able to reliably bring child to clinic visits and provide trustworthy ratings, interacting regularly with the child
- Ability of child to swallow the study medication
- Stable concomitant medications for at least 2 weeks (4 weeks if fluoxetine was taken)
- No planned changes in psychosocial interventions during the trial
You will not qualify if you...
- 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 kidney disease)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Stanford University School of Medicine
Stanford, California, United States, 94305
Actively Recruiting
Research Team
N
Nina Raman
CONTACT
B
Briana Hernandez
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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