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).