A Study of Esomeprazole in Children with Autism
- Registration Number
- NCT03866668
- Lead Sponsor
- Stanford University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- All
- Target Recruitment
- 25
- 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.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Esomeprazole Esomeprazole Esomeprazole Dosage (Weight Less Than 20 kg) -- 10 mg QD for 8 weeks Esomeprazole Dosage (Weight 20 kg or Greater) -- 10 mg QD for 4 weeks followed by 20 mg QD for 4 weeks
- Primary Outcome Measures
Name Time Method Change from Baseline on the Social Responsiveness Scale, 2nd Edition (SRS-2) Baseline, 4 Weeks, 8 Weeks Social Responsiveness Scale (SRS) raw scores measure social abilities with lower raw scores meaning better social abilities. (Raw Score Range: 0 - 195)
- Secondary Outcome Measures
Name Time Method Change from Baseline on the Aberrant Behavior Checklist, 2nd Edition (ABC-2) Baseline, 4 Weeks, 8 Weeks Higher scores indicate more symptoms, lower scores indicate fewer symptoms. Irritability scores can range from 0-45. Lethargy scores can range from 0-48. Stereotypy scores can range from 0-21. Hyperactivity scores can range from 0-48. Inappropriate speech scores can from 0-12.
Trial Locations
- Locations (1)
Stanford University School of Medicine
🇺🇸Stanford, California, United States
Stanford University School of Medicine🇺🇸Stanford, California, United States