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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
bumetanide tablets, oral intake, 0.5mg, twice daily, respectively at 8 am and 4 pm
placebo tablets, oral intake, 0.5mg, twice daily, respectively at 8 am and 4 pm
Xinhua Hospital
Shanghai, Shanghai Municipality, China
Childhood Autism Rating Scale(CARS)
CARS is a behaviour-rating scale used to assess the presence and severity of the symptoms of autism spectrum disorder
Time frame: Day 0 and Day 90
Clinical Global Impressions Scale (CGI)
CGI is a scale used to assess the severity of the illness and the global improvement of the patient under intervention
Time frame: Day 0 and Day 90
Social Responsiveness Scale (SRS)
SRS is a questionnaire used to assess the presence and severity of social impairment.
Time frame: Day 0 and Day 90
Autism Diagnostic Observation Schedule (ADOS)
The ADOS is a structured play session conducted by clinicians, with the total score combines the Social and Communication domain items.
Time frame: Day 0 and Day 90
Short Sensory Profile Report
The Sensory Profile is a measure of children's responses to sensory events in daily life. The caregiver completes the Sensory Profile by assessing the frequency of the child's responses to certain sensory processing, modulation, and behavioral/emotional events as described in the 125 items.
Time frame: Day 0 and Day 90
Symbolic Play Test
Symbolic Play Test is a nonverbal measure of symbolic functioning in participants aged 12-36 months. The test does not require any expressive speech, and is therefore appropriate for use with all participants with ASD. Participants are sequentially presented with four sets of toys, and their spontaneous manipulation of the objects is observed and recorded on a standardized checklist.
Time frame: Day 0 and Day 90
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Chinese Communicative Development Inventory
The Chinese Communicative Development Inventories (CCDI) is a questionnaire that is used to direct measures of the participants' language.Change between day 0 and day 90 of the result of the Chinese Communicative Development Inventory
Time frame: Day 0 and Day 90