Autism Spectrum Disorder Clinical Trial
Official title:
Efficacy of Esomeprazole in Children and Adolescents With Autism Spectrum Disorder
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.
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.
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