Esomeprazole for social communication problems in young children with autism

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2, prospective, open-label trial will enroll about 25 children with autism spectrum disorder aged 2 to 6 years and treat them with esomeprazole for 12 weeks. Diagnosis must be confirmed by DSM-5 criteria and standardized tools such as the Autism Diagnostic Interview-Revised and the Autism Diagnostic Observation Schedule or CARS-2, and caregivers provide regular outcome ratings. Participants must be physically healthy, able to swallow the medication, on stable concomitant medications, and have no planned changes in psychosocial interventions during the trial. Clinical and caregiver-rated measures of social communication will be collected throughout the treatment period to look for changes from baseline.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* outpatients 2 to 6 years of age at time of consent;
* 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 Criteria:

* 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);
* recent or planned hospitalizations;
* history of hypersensitivity to benzimidazole;
* taking concomitant medications that interact with the study drug.

Where it's running

• Stanford University School of Medicine
  Stanford, California, United States Recruiting

Study contacts

• Principal investigator: Antonio Hardan, MD — Stanford University
• Study coordinator: Nina Raman
• Email: autismdd@stanford.edu
• Phone: (650)736-1235

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.