Efficacy of Esomeprazole in Children and Adolescents With Autism Spectrum Disorder

Autism Spectrum Disorder Clinical Trial

Official title:

Efficacy of Esomeprazole in Children and Adolescents With Autism Spectrum Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03669159
• Other study ID #: 201705141MIND
• Status: Recruiting
• Phase: Phase 2
• Start date: January 1, 2018
• Est. completion date: December 2018

Study information

• Verified date: February 2018
• Source: National Taiwan University Hospital
• Contact: Susan Shur-Fen Gau
• Phone: 02-23123456
• Email: gaushufe[@]ntu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

Investigator will recruit children and adolescents with ASD consecutively from Children's Mental Health Center, Department of Psychiatry, National Taiwan University Hospital. The estimated sample size is 90 if they meet the following inclusion and exclusion criteria.

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive
• Disease

Intervention

Drug:
• Nexium
Investigator will conduct a 3-month esomeprazole with 3-month of treatment in a sample of 60 children and adolescents with ASD, aged 5-18.
• Placebo
Investigator will conduct a 3-month placebo with 3-month of treatment in a sample of 30 children and adolescents with ASD, aged 5-18.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline ADOS at 3 months	The Chinese version of the Autism Diagnosis Observation Scale(ADOS): the ADOS is a comprehensive, investigator-based procedure that places the child in naturalistic social situations demanding specific social and communication reactions. Behaviors are coded in the areas of social communication, social relatedness, play, imaginative of materials, and restricted and/or repetitive behaviors. The ADOS requires approximately 50 minutes and includes four modules: preverbal children, children who have phrase speech, fluent children, and fluent older adolescents and adults.	Baseline, Month2 and Month 3
Secondary	Change from baseline CGI-S at 3 months	Clinical Global Impression-Severity(CGI-S) of ASD symptoms: the CGI-S and CGI-I are single-item rating of the clinician's assessment of the global severity of clinical symptoms in relation to the clinician's total experience with other patients (patients with ASD in this study). Severity and improvement are rated on a 7-point scale (from 1 = normal, not at all ill, to 7 = among the most extremely ill) and (from 1 = very much improved, to 7 = very much worse).	Baseline, Month1, Month2 and Month 3
Secondary	Change from baseline CGI-I at 3 months	Clinical Global Impression-improvement(CGI-I) of ASD symptoms: the CGI-S and CGI-I are single-item rating of the clinician's assessment of the global severity of clinical symptoms in relation to the clinician's total experience with other patients (patients with ASD in this study). Severity and improvement are rated on a 7-point scale (from 1 = normal, not at all ill, to 7 = among the most extremely ill) and (from 1 = very much improved, to 7 = very much worse).	Baseline, Month1, Month2 and Month 3