- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Shanghai
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Shanghai, Shanghai, China, 200000
- Xinhua Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Bumetanide group
Double-blind phase: in the first 3 months, patients will receive the experimental treatment - bumetanide, oral intake, 0.5mg/time, twice a day; Open-label phase: after 3 month double-blined treatment, all the patients will receive 3-month bumetanide treatment - oral intake, 0.5mg/time, twice a day.
|
bumetanide tablets, oral intake, 0.5mg, twice daily, respectively at 8 am and 4 pm
|
Placebo Comparator: Control group
Double-blind phase: in the first 3 months, patients will receive the placebo - oral intake, 0.5mg/time, twice a day; Open-label phase: after 3 month double-blined treatment, patients in this group will receive 3-month bumetanide treatment - oral intake, 0.5mg/time, twice a day.
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placebo tablets, oral intake, 0.5mg, twice daily, respectively at 8 am and 4 pm
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Day 0 and Day 90
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Day 0 and Day 90
|
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.
|
Day 0 and Day 90
|
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.
|
Day 0 and Day 90
|
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.
|
Day 0 and Day 90
|
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.
|
Day 0 and Day 90
|
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
|
Day 0 and Day 90
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Day 0 and Day 90
|
Multichannel EEG Signals
Time Frame: Day 0 and Day 90
|
Change in brain Multichannel EEG signals
|
Day 0 and Day 90
|
Genome wide association study from blood sample
Time Frame: Day 90
|
Selection and study of susceptible genes
|
Day 90
|
Analysis of metabolites from blood sample
Time Frame: Day 0 and Day 90
|
Metabonomics research
|
Day 0 and Day 90
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Fei Li, doctor, Xinhua hospital Affilated to Shanghai Jiao Tong University School of Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Neurodevelopmental Disorders
- Autistic Disorder
- Autism Spectrum Disorder
- Child Development Disorders, Pervasive
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Natriuretic Agents
- Membrane Transport Modulators
- Diuretics
- Sodium Potassium Chloride Symporter Inhibitors
- Bumetanide
Other Study ID Numbers
- XH-16-048
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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