]>
IRCT20211118053097N1 IRCT 2022-03-26 Shiraz University of Medical Sciences An investigation on the effect of memantine on children with autistic spectrum disorder 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 2022-04-04 anticipated 52 Complete https://irct.ir/trial/61490 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 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. N/A patients diagnosed with ASD. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: Demographic data and data related to final outcome will be shared by maintaining confidentiality. When: 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: Academics employed at various research/university institutions and affiliated industries receiving permission from the research office of shiraz university of medical science. Conditions: For Academic and research goals only. Where to obtain: Narjesrb@gmail.com, Imam Reza clinic, Namazi sq, shiraz. Narjes raja-Beheshti How to obtain: 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. Comments:
public Narjes Raja-beheshti
Imam Reza Clinic, Namazi Sq, Shiraz, Fars.
Shiraz Iran (Islamic Republic of) 7134814734 +98 71 3212 7000 Narjesrb@gmail.com Shiraz University of Medical Sciences scientific Pegah Katibeh
Imam Reza Clinic, Namazi Sq, Shiraz, Fars.
Shiraz Iran (Islamic Republic of) 7134814734 +98 71 3212 7000 pegahkatibeh@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) 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 4 years 12 years Both Intolerance to Memantine Patients and/or their caregiver’s disinclination to continuing with trail F84.0 Autistic disorder Treatment - Drugs Treatment - Drugs 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. 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. Electroencephalography analysis. Timepoint: Before the treatment and 10 weeks after treatment onset. Method of measurement: Using the Electroencephalograph and analysis of activities. ABC questionnaire (measuring cognitive activity). Timepoint: Before the treatment and 10 weeks after treatment onset. Method of measurement: Filling ABC autism questionnaire. Shiraz University of Medical Sciences Approved 2021-09-07 Ethics committee of shiraz University of Medical Sciences Zand St., Shiraz, Iran shiraz Fars Iran (Islamic Republic of)