Evaluating the effect of Bumetanide on brain functions in facial emotion recognition and attention to eyes, in children and adolescence with autism spectrum disorder
the effect of Bumetanide on the ability to recognize emotional faces (accuracy and processing speed) and attention to eyes in children and adolescents with autism spectrum disorder
Design
a pretest-posttest single group clinical trial.
Settings and conduct
After completing the consent form, the subjects received Bumetanide for three months. Evaluations performed on all subjects included Childhood Autism Rating Scale (CARS), Semi-structured Diagnostic Interview (K-SADS-PL), Social Responsiveness Scale (SRS), Wechsler Intelligence Scale for Children - Revised Form (WISC-R) and evaluation of ability to recognize emotional faces using event-related potential (ERP). Finally, the results of the evaluations were analyzed by repeated measures ANOVA, Bonferroni, paired t-test and Pearson correlation coefficient.
Institute for Cognitive Sciences Studies
Participants/Inclusion and exclusion criteria
Participants: A group of 20 people
Inclusion criteria:
With autism spectrum disorder level 1 in the range of 7 to 16 years old,
IQ above 70
Exclusion criteria:
Karyotype abnormalities or neurological records including epilepsy and febrile seizures
Allergy to sulfonamides
liver or kidney dysfunction, heart disease
Intervention groups
Intervention group
The subjects got for 3 month 1 mg Bumetanide (0.5 mg twice a day) purchased from the Niche Generics Limited Company in Ireland , which was provided weekly to their parents. They were treated with this medication for three months
Main outcome variables
Recognizing emotional faces; Attention to eyes
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180901040915N1
Registration date:2019-07-06, 1398/04/15
Registration timing:retrospective
Last update:2019-07-06, 1398/04/15
Update count:0
Registration date
2019-07-06, 1398/04/15
Registrant information
Name
Mehdi Tehrani-doost
Name of organization / entity
Institute for Cognitive Science Studies
Country
Iran (Islamic Republic of)
Phone
+98 21 7629 1130
Email address
tehranid@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2018-05-05, 1397/02/15
Actual recruitment start date
2017-09-23, 1396/07/01
Actual recruitment end date
2018-05-05, 1397/02/15
Trial completion date
2018-09-21, 1397/06/30
Scientific title
Evaluating the effect of Bumetanide on brain functions in facial emotion recognition and attention to eyes, in children and adolescence with autism spectrum disorder
Public title
Effect of Bumetanide on brain function in autism spectrum disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosed as a autism spectrum disorder, level 1 (needing support) according to DSM-V
IQ above 70
Exclusion criteria:
Karyotype abnormalities or neurological records including epilepsy and febrile seizures
A history of allergy to sulfonamides
liver or kidney dysfunction, heart disease
Age
From 7 years old to 16 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
20
Actual sample size reached:
20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran, , IRAN
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2017-03-08, 1395/12/18
Ethics committee reference number
IR.IUMS.REC.1395.4537
Health conditions studied
1
Description of health condition studied
Autism Spectrum Disorder
ICD-10 code
F84.0
ICD-10 code description
Autistic disorder
Primary outcomes
1
Description
Evaluation of the latency and amplitude of brain signals faced with emotional faces
Timepoint
Before the intervention and one week after the intervention
Method of measurement
Brain Event Related Potentials Recording
2
Description
Attention to eyes
Timepoint
Before the intervention and one week after the intervention
Method of measurement
Eye Track Recording
Secondary outcomes
1
Description
severity of the symptoms
Timepoint
One week before the intervention, sixth week of the intervention, and one week after the intervention
Method of measurement
Interview with the parents and completing the "Childhood Autism Rating Scale" questionnaire
2
Description
Evaluation of the communication and social relationships
Timepoint
One week before the intervention, sixth week of the intervention, and one week after the intervention
Intervention group: Receiving 1 mg (0.5 m.g in the morning, 0.5 m.g in the evening) Bumetanide (Purchased from Niche Generics Limited Ireland) twice a day for three months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Tehranidoost`s Clinic
Full name of responsible person
Dr. Mehdi Tehranidoost
Street address
Third Floor, Baran Complex, Falsafi Alley, Shariati Street
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 2225 2553
Email
tehranid@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Institute for Cognitive Science Studies
Full name of responsible person
Dr. Javad Hatami
Street address
Shahid Chamran Blvd, Safir Omid Blvd, Edalat Squar, Phase 4 of Pardis City
City
Pardis
Province
Tehran
Postal code
1658344575
Phone
+98 21 7629 1130
Email
ICSS@iricss.org
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Institute for Cognitive Science Studies
Proportion provided by this source
20
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
2
Sponsor
Name of organization / entity
Cognitive Sciences & Technologies Council
Full name of responsible person
Dr. Majid Nili
Street address
No. 35, Alvand Street, Argantin Square, Tehran
City
Tehran
Province
Tehran
Postal code
1658344575
Phone
+98 21 8819 4961
Email
research.project@cogc.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Cognitive Sciences & Technologies Council
Proportion provided by this source
70
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
3
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Seyed Kazem Malakouti
Street address
Vice-Chancellor for Research and Technology, Iran University of Medical Sciences, Kazem Besarati St. Kabiri Tameh Ave. Shahid Hemmat Expy, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 2503
Email
malakouti.k@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?