A Study of Esomeprazole in Children With Autism

Trial ID or NCT#

NCT03735888

Status

not recruiting iconNOT RECRUITING

Purpose

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;
  2. - males and females who are physically healthy;
  3. - 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;
  4. - care provider who could reliably bring subject to clinic visits, could provide trustworthy ratings, and interacted with subject on a regular basis;
  5. - ability of subject to swallow the compound;
  6. - stable concomitant medications for at least 2 weeks (4 weeks if patient took fluoxetine);
  7. - 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;
  2. - prior adequate trial of Esomeprazole;
  3. - active medical problems such as unstable seizures, or significant physical illness (e.g., serious liver or renal pathology).

Investigator(s)

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

Contact us to find out if this trial is right for you.

Contact

Robin Libove
(650)736-1235