Esomeprazole (Nexium) for social communication difficulties in children aged 2 to 6 with autism

You may qualify if

• 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.

You can't join if

• 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.