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IRCT20160905029714N2 IRCT 2022-03-08 Tehran University of Medical Sciences evaluation of the effect dual combination of Donepezil and Betahistine in improving the symptoms of autism spectrum disorder evaluation of the effect of Donepezil in comparison with dual combination of Donepezil and Betahistine in improvement of children with autism spectrum disorder - a randomized clinical trial 2022-02-20 anticipated 30 Complete https://irct.ir/trial/61306 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, a simple randomization method is used, in which 30 pockets (according to the number of participants) are placed on the table. Each pocket contains one of the two drug combinations (A or B). Participants randomly select one pocket and will be placed in that group. 3 Autism Spectrum Disorder. Intervention 1: Intervention group:17 patients will be received a combination of donepezil and betahistine along with their other previous medications. Starting with 2.5mg/day in the first week and then Increase to 5 mg/day in the next 4 weeks and if it is tolerated and no side effects was seen, increase to 7.5mg/day in the sixth week and finally 10 mg/day in the last 4 weeks. The dose of betahistine used in this study is 16 mg twice daily for weight less than 50 kg and the dose of 24 mg twice daily for weights over 50 kg. Children will receive 4mg twice a day in the first week and 8mg twice a day in the second week, and if the drug is tolerable and there are no side effects, the dose will be increased to 16mg twice a day from the third week. For children over 50 kg, these doses will be 8, 16 and 24mg twice a day. Intervention 2: Control group: 17 patients will be received donepezil for 10 weeks along with other previous medications. Dosage for donepezil is 2.5 mg in the first week, 5 mg in the second to fifth week for 4 weeks, increase to 7.5 mg in the sixth week and in case of tolerance and no side effects, increase to a dose of 10md/day. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is According to the consent form, the participants’ information data is only for use in this current study and in order to publish the data, re-permission is required and its program is still unknown.
public Chohedri Elnaz
Department of child and adolescent psychiatry., Roozbeh hospital., South Karegar St., Tehran
Tehran Iran (Islamic Republic of) 1333715914 +98 21 5541 9151 elnaz_chohedri@yahoo.com Tehran University of Medical Sciences scientific Alaghband rad Javad
Department of child and adolescent psychiatry., Roozbeh hospital., South Karegar St., Tehran
Tehran Iran (Islamic Republic of) 1333715914 +98 21 5541 9151 dralaghbandrad@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) All children and adolescents aged 6-18 years with autism spectrum disorder whose diagnosis has been confirmed by a child and adolescent psychiatrist. Patients in a relative remission over the past 4 weeks and no dose adjustment was required. If there is other comorbid psychiatric disorders, they should be controlled and not in the acute phase of the disease 6 years 18 years Both If there is a concomitant genetic disorder, seizure or medical illness, these people will be excluded from the study If comorbid psychiatric disorders recur during the study, the individuals will be excluded from the study. Patients who change their medication regimen or dose during the 4 weeks before the start of the trial or during the entire trial period will also be excluded from the study Patients who do not tolerate the intended dose or experience a serious complication will be excluded from the study. F84.0 Autistic disorder Treatment - Drugs Treatment - Drugs Intervention group:17 patients will be received a combination of donepezil and betahistine along with their other previous medications. Starting with 2.5mg/day in the first week and then Increase to 5 mg/day in the next 4 weeks and if it is tolerated and no side effects was seen, increase to 7.5mg/day in the sixth week and finally 10 mg/day in the last 4 weeks. The dose of betahistine used in this study is 16 mg twice daily for weight less than 50 kg and the dose of 24 mg twice daily for weights over 50 kg. Children will receive 4mg twice a day in the first week and 8mg twice a day in the second week, and if the drug is tolerable and there are no side effects, the dose will be increased to 16mg twice a day from the third week. For children over 50 kg, these doses will be 8, 16 and 24mg twice a day. Control group: 17 patients will be received donepezil for 10 weeks along with other previous medications. Dosage for donepezil is 2.5 mg in the first week, 5 mg in the second to fifth week for 4 weeks, increase to 7.5 mg in the sixth week and in case of tolerance and no side effects, increase to a dose of 10md/day. Social responsiveness score in SRS-2 questionnaire. Timepoint: Week 0(before intervention), week 5, week 10(after finishing intervention). Method of measurement: Social Responsiveness Scale (SRS-2 questionnaire). Scale of behavioral disturbance in Aberrant Behavior Checklist (ABC-2). Timepoint: Week 0(before intervention), week 5, week 10(after finishing intervention). Method of measurement: ABC-2 questionnaire. PedsQL total score. Timepoint: Week 0, week 5 , week 10. Method of measurement: PedsQL questionnaire parent form. Tehran University of Medical Sciences Approved 2021-11-16 Research Ethics committees of School of Medicine - Tehran University of Medical Sciences Office of the Vice Chancellor for Research, 1st floor ,Building No.1, Poursina St. ,Ghods St. , Enghelab St , Tehran Tehran Tehran Iran (Islamic Republic of)