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NCT Number: NCT03156153

A Study of Bumetanide for the Treatment of Autism Spectrum Disorders

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.

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Key information

Conditions

Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

3 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Xinhua Hospital

Shanghai, Shanghai Municipality, 200000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

The patients, aged from 3 to 6 years old, were given the diagnosis of ASD according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) , by a team of autism experts; Scores for Children Autism Rating Scale (CARS) were more than 30; Signed Informed Consents were provided by parents.

Exclusion criteria

Liver and kidney dysfunction; With a history of allergy to sulfa drugs; abnormal ECG; chromosomal abnormality; suffering from nervous system diseases (such as epilepsy, schizophrenia, and so on); using the melatonin treatment for sleep disorders or withdrawal less than three weeks.

Treatment and study plan

Bumetanide

Drug

bumetanide tablets, oral intake, 0.5mg, twice daily, respectively at 8 am and 4 pm

Placebo

Drug

placebo tablets, oral intake, 0.5mg, twice daily, respectively at 8 am and 4 pm

Primary outcomes

  1. Childhood Autism Rating Scale(CARS)

    Time frame: Day 0 and Day 90

    CARS is a behaviour-rating scale used to assess the presence and severity of the symptoms of autism spectrum disorder

Secondary outcomes

  1. Clinical Global Impressions Scale (CGI)

    Time frame: Day 0 and Day 90

    CGI is a scale used to assess the severity of the illness and the global improvement of the patient under intervention

  2. Social Responsiveness Scale (SRS)

    Time frame: Day 0 and Day 90

    SRS is a questionnaire used to assess the presence and severity of social impairment.

  3. Autism Diagnostic Observation Schedule (ADOS)

    Time frame: Day 0 and Day 90

    The ADOS is a structured play session conducted by clinicians, with the total score combines the Social and Communication domain items.

  4. Short Sensory Profile Report

    Time frame: Day 0 and Day 90

    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.

  5. Symbolic Play Test

    Time frame: Day 0 and Day 90

    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.

  6. Chinese Communicative Development Inventory

    Time frame: Day 0 and Day 90

    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

Other outcomes

  1. MRI Structure Imaging and Spectrum imaging, data analysis

    Time frame: Day 0 and Day 90

    Change of structure of the brain and the GABA-neurotransmitters in specific brain regions of the brain.

  2. Multichannel EEG Signals

    Time frame: Day 0 and Day 90

    Change in brain Multichannel EEG signals

  3. Genome wide association study from blood sample

    Time frame: Day 90

    Selection and study of susceptible genes

  4. Analysis of metabolites from blood sample

    Time frame: Day 0 and Day 90

    Metabonomics research

Sponsors and collaborators

Lead sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Other

Collaborators

  • Shanghai Jiao Tong University School of Medicine

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
May 17, 2017
Registry last updated
Mar 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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