NCT03156153

A Study of Bumetanide for the Treatment of Autism Spectrum Disorders

A Study of Bumetanide for the Treatment of Children With Autism Spectrum Disorder：a Randomized Double-blind Placebo-controlled Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 3 Years – 6 Years
• Healthy volunteers: Not accepted

Summary

The investigators are going to carry out a randomized double-blind placebo-controlled trial to study the efficiency and mechanism of bumetanide on the treatment of children with Autism Spectrum Disorder.

Detailed description

In consideration of the increasing number of autistic children and poor intervention effect in China, it is an urgent to find some effective medicine. Some studies have reported bumetanide, a classic diuretic, could improve autistic behaviors in both animal model and humans; while the efficiency of bumetanide on Chinese autistic chilren is unkonwn and the underlying mechanisms remain unfolding. The investigators aim at investigating whether bumetanide would improve the clinical symptoms in Chinese children with autism within a safe dosage and further study the physiological mechanism beneath.The investigators will regularly assess the participants' autism-related symptoms during medication, as well as the adverse effects of each patient. The investigators will carry out genome-wide association analysis (GWAS) from blood sample, related metabolites in nervous system and compare the concentration of the neurotransmitter in autistic brain before and after 3 months' treatmeat,and also will collect the EEG signal in autistic chilldren when the participants performing certain tasks before and after 3 months' treatment.

Conditions

• Autism Spectrum Disorder

Interventions

Type	Name	Description
DRUG	Bumetanide	bumetanide tablets, oral intake, 0.5mg, twice daily, respectively at 8 am and 4 pm
DRUG	Placebo	placebo tablets, oral intake, 0.5mg, twice daily, respectively at 8 am and 4 pm

Timeline

• Start date: 2017-05-24
• Primary completion: 2019-07-08
• Completion: 2019-07-10
• First posted: 2017-05-17
• Last updated: 2021-03-01

Locations

1 site across 1 country: China