Evaluation of the efficacy of memantine in improvement of behavioral disorders and electroencephalographic findings in children with autistic spectrum disorder aged 4-12 years old
Evaluation of the efficacy of memantine in the improvement of behavioural disorders and electroencephalographic findings in children with autistic spectrum disorder
Design
Two arms parallel-group randomized trial single-blind, on 52 participants using simple randomization.
Settings and conduct
Patients who refer to imam Reza clinic of shiraz university of medical science and diagnosed with autism based on DSM 5 and, using GARS questionnaire aged between 4 – 12 years old with normal EEG would be entered into the study and would fill out ABC questionnaire and receive their treatment according to their group of intervention. After 10 weeks patients would repeat their EEG test and fill out the ABC questionnaire again.
Participants/Inclusion and exclusion criteria
- Patients diagnosed with ASD according to DSM 5
- Patients with no previous history of epilepsy and/or abnormal electroencephalography
- Patients aged between 4 to 12 years old
Intervention groups
There would be two parallel-group: 1. This group would be patients receiving the normal treatment (risperidone) 2. The second group would be the intervention group that receive memantine as an adjunct treatment (risperidone + memantine)
Main outcome variables
1. ABC questionnaire scores and results
2. EEG analysis and changes
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211118053097N1
Registration date:2022-03-26, 1401/01/06
Registration timing:prospective
Last update:2022-03-26, 1401/01/06
Update count:0
Registration date
2022-03-26, 1401/01/06
Registrant information
Name
Hossein Bayat
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3235 5576
Email address
hbayat@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-04, 1401/01/15
Expected recruitment end date
2022-06-10, 1401/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy of memantine in improvement of behavioral disorders and electroencephalographic findings in children with autistic spectrum disorder aged 4-12 years old
Public title
An investigation on the effect of memantine on children with autistic spectrum disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients diagnosed with ASD according to DSM 5
Patients with no previous history of epilepsy and/or abnormal electroencephalography
Patients aged between 4 to 12 years old
Exclusion criteria:
Intolerance to Memantine
Patients and/or their caregiver’s disinclination to continuing with trail
Age
From 4 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment to intervention and control groups is done using a random number table. After specifying the statistical population, each participant is given a two-digit code, and a row or a column of the random number table is randomly assigned. Select and continue in the same direction. In this way, the group of intervention or control is determined. Then, due to the two-sided blindness of the study, the necessary treatment is given for each group. Participants are entered into the study by a psychiatrist. Determining the random allocation sequence and the list of intervention and control groups will be done by the statistical consultant and SPSS software.
Blinding (investigator's opinion)
Double blinded
Blinding description
This is a double-sided blind study and the main researchers, theData and Safety Monitoring Board, have information about the type of drugs used and the grouping of all the individuals. Participants in the project do not know the type and specifications of the drug used and the drugs would be provided by their caregivers. Evaluators are aware of the type of grouping of individuals.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of shiraz University of Medical Sciences
Street address
Zand St., Shiraz, Iran
City
shiraz
Province
Fars
Postal code
71348-14336
Approval date
2021-09-07, 1400/06/16
Ethics committee reference number
IR.SUMS.MED.REC.1400.298
Health conditions studied
1
Description of health condition studied
patients diagnosed with ASD
ICD-10 code
F84.0
ICD-10 code description
Autistic disorder
Primary outcomes
1
Description
Electroencephalography analysis
Timepoint
Before the treatment and 10 weeks after treatment onset
Method of measurement
Using the Electroencephalograph and analysis of activities
2
Description
ABC questionnaire (measuring cognitive activity)
Timepoint
Before the treatment and 10 weeks after treatment onset
Method of measurement
Filling ABC autism questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: group 1 would receive risperidone with 0.25 mg/ daily initiation dose for under 20kg weight and 0.5mg/daily for above 20kg. they would also receive memantine (Ⓒ Osvah Pharmaceutical Co.) with 5 mg/daily initial dose and 5mg/weekly increasing dose until reaching 15mg/daily for children weighted between 10 to 40 kg and for above 40kg 20mg/daily.
Category
Treatment - Drugs
2
Description
Control group: group 2 would receive risperidone with 0.25 mg/ daily initiation dose for under 20kg weight and 0.5mg/daily for above 20kg.
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
50
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
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Narjes Raja-beheshti
Position
fellowship student
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Imam Reza Clinic, Namazi Sq, Shiraz, Fars.
City
Shiraz
Province
Fars
Postal code
7134814734
Phone
+98 71 3212 7000
Email
Narjesrb@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Pegah Katibeh
Position
assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Imam Reza Clinic, Namazi Sq, Shiraz, Fars.
City
Shiraz
Province
Fars
Postal code
7134814734
Phone
+98 71 3212 7000
Fax
Email
pegahkatibeh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Hossein Bayat
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Speech therapy
Street address
Shiraz University of Medical Science, Zand blvd
City
Shiraz
Province
Fars
Postal code
71354664546
Phone
+98 71 3235 5576
Fax
Email
hbayat@sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Demographic data and data related to final outcome will be shared by maintaining confidentiality.
When the data will become available and for how long
De-identified data will be available starting 1 year after publication with permission of the research department of shiraz university of medical science.
To whom data/document is available
Academics employed at various research/university institutions and affiliated industries receiving permission from the research office of shiraz university of medical science.
What processes are involved for a request to access data/document
The applicant would be asked to provide a formal request letter containing the importance of the data and the project processes with a permission letter from the research office of shiraz university of medical science. Following the receipt of the request letter, the data would be provided maxim within 1 month.