Autism, Autism Spectrum Disorder
Conditions
Keywords
Esomeprazole
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.
Interventions
DRUGEsomeprazole
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
Sponsors
Stanford University
SPARK (Stanford University)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 6 Years
Healthy volunteers
No
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 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.
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
CONTACTNina Raman
CONTACTBriana Hernandez
PRINCIPAL_INVESTIGATORAntonio Hardan, MD
Stanford University
Outcome results
None listed