A Study of Esomeprazole in Children With Autism

Trial ID or NCT#



not recruiting iconNOT RECRUITING


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.

Official Title

An Open-Label Pilot Study of Esomeprazole in Children With Autism

Eligibility Criteria

Ages Eligible for Study: 2 Years to 6 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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; - 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 Criteria:
  1. - 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).


Antonio Hardan, M.D.
Antonio Hardan, M.D.
Professor of Psychiatry and Behavioral Sciences

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Lakshmi Vrittamani