A Study of Esomeprazole in Children With Autism

Inclusion Criteria:

- 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:

- 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).