Efficacy of Bumetanide in Children With Autism Spectrum Disorder Guided by Peripheral Blood Biomarkers and Machine Learning Models: A Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The objective of this study is to learn if bumetanide could alleviate the clinical symptoms in children with autism spectrum disorder (ASD), who has been predicted as high responders to bumetanide via a cytokine-based predictive model. The Eligible ASD participants identified as high responder to bumetanide will be randomly assigned to either the experimental group or the control group. Participants in the experimental group will receive bumetanide interventions, along with the behavioral interventions, for three months. Participants in the control group will only undergo behavioral interventions. The clinical symptoms and potential adverse effects will be closely monitored throughout the intervention period.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 3
Maximum Age: 6
Healthy Volunteers: f
View:

• Children aged between 3 and 6 years old

• Meeting the ASD diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)

• Meeting the ASD diagnostic criteria of the Diagnostic Observational Scale for Autism, Second Edition(ADOS-2)

• CARS total score ≥ 30

• Identified as high responder to bumetanide by machine learning algorithms

• Obtaining informed consent from the legal guardian

Locations
Other Locations
China
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
RECRUITING
Shanghai
Contact Information
Primary
Fei Li, MD, PhD
feili@shsmu.edu.cn
+86-02125077461
Time Frame
Start Date: 2025-06-04
Estimated Completion Date: 2026-05-30
Participants
Target number of participants: 66
Treatments
Experimental: bumetanide plus treatment as usual (TAU)
Participants in experimental group will receive bumetanide, along with treatments as usual (i.e. behavioral interventions)
Other: Treatment as usual (TAU)
Participants will undergo treatment as usual, such as behavioral interventions
Related Therapeutic Areas
Sponsors
Leads: Fei Li

This content was sourced from clinicaltrials.gov