Education and Training
A Study of Esomeprazole in Children With Autism
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.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Esomeprazole
Eligibility
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).
Ages Eligible for Study
2 Years - 6 Years
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Robin Libove
(650)736-1235
Not Recruiting