Efficacy of Esomeprazole in Children and Adolescents With Autism Spectrum Disorder

  • STATUS
    Recruiting
  • participants needed
    90
  • sponsor
    National Taiwan University Hospital
Updated on 8 November 2020

Summary

This treatment study of esomeprazole in ASD will be the first study in the world with significant originality and innovation. The investigators anticipate seeing the effect of esomeprazole on improving the core symptoms of ASD, particularly within the social communication and cognition domains.

Description

Due to lifelong impairment and no effective treatment, autism spectrum disorder (ASD) has been prioritized for molecular genetics and brain research to understand the pathogenesis mechanism of ASD to develop effective early detection, diagnosis, prevention, and treatment for ASD. Some pilot reports suggested that D-amino acid oxidase inhibitor (DAOI) is effective in treating autism. Previous research of investigators has discovered esomeprazole would be a good inhibitor of DAOI. This project will be the first clinical trial in the world to examine the effect of esomeprazole in children with ASD.

Specific Aims:

  1. To investigate the improvement of specific ASD core symptoms of social communication and interactions as well as stereotyped behaviors and investigator's impression of clinical symptoms severity and improvement.
  2. To investigate the changes of several aspects of autistic, ADHD and oppositional/impulsive traits, a wide range of social functions and neurocognitive functions.
  3. To examine the pharmacodynamics of esomeprazole and its parent drug.

Details
Condition Pervasive developmental disorder
Treatment Placebo, Nexium
Clinical Study IdentifierNCT03669159
SponsorNational Taiwan University Hospital
Last Modified on8 November 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Aged 5 to 18, who were diagnosed with ASD according to DSM-5 diagnostic criteria
The clinical diagnosis is confirmed by the Autism Diagnostic Interview - Revised (ADI-R) interview with parents and the Autism Diagnostic Observation Scale interview with participants
After detailed explanation of the objectives and procedures of this clinical trial and reassurance with voluntary participation, the participants (or child assent) and their parents provided written informed consent to the study

Exclusion Criteria

Abnormal liver and renal functions
Osteopenia
Major psychiatric disorders such as a history of schizophrenia, bipolar disorder, major depression
Neurological disorders
Addition of Substances Including Alcohol
Allergy to Esomeprazole
Exhibit Significant Musculoskeletal Problems
Simultaneously Taking Clopidogrel
Using PPI For Treatment of Peptic Ulcer and Being Recommended Not to Change to Esomeprazole After Medical Evaluation
Cannot Follow Instructions
Clear my responses

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Step 1 Connect with a study center
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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