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
Comparison of the effectiveness of Donpezil with combination therapy of betahistine (histamine H3 receptor antagonist) and donepezil (acetylcholinesterase inhibitor) in improving the symptoms of children with autism spectrum disorder
Design
This study is a double-blind clinical trial. In this study, 34 children with ASD who were referred to the pediatric clinic of Roozbeh Hospital were randomly divided into two groups. One group is treated with donepezil (along with previous drugs) for 10 weeks and the other group is treated with a combination of betahistine and donepezil. All patients before, during the study and after the intervention were evaluated by PedsQL, SRS-2, ABC-2 tests and the results were analyzed by SPSS program.
Settings and conduct
After being visited in the clinic, patients receive their medications from the researcher depending on which group they belong to, and take new medications for 10 weeks in addition to the previous treatment regimen. Patients' symptoms are compared by 3 questionnaires mentioned in the hospital at the beginning of the study, in the half and after the end of the study.
Participants/Inclusion and exclusion criteria
inclusion criteria:
children and adolescents aged 6-18 years with confirmed diagnosis of ASD
No change in pharmacologic treatment was done at least for the past 4 weeks
Exclusion criteria:
Patients with a concomitant genetic disorder, seizure or medical illness.
Patients with very severe autism disorder who may need to change the medication
Intervention groups
The participants are randomly divided into two groups of 17 people (A and B).
Group A is treated with donepezil for 10 weeks and Group B is treated with the combination of donepezil and betahistine for 4 weeks along with previous drugs.
Main outcome variables
SRS questionnaire total score
ABC-2 questionnaire total score
PedsQL questionnaire total score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160905029714N2
Registration date:2022-03-08, 1400/12/17
Registration timing:registered_while_recruiting
Last update:2022-03-08, 1400/12/17
Update count:0
Registration date
2022-03-08, 1400/12/17
Registrant information
Name
Elnaz Chohedri
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3627 9319
Email address
echohedri@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-20, 1400/12/01
Expected recruitment end date
2022-05-21, 1401/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
evaluation of the effect dual combination of Donepezil and Betahistine in improving the symptoms of autism spectrum disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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.
Age
From 6 years old to 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics committees of School of Medicine - Tehran University of Medical Sciences
Street address
Office of the Vice Chancellor for Research, 1st floor ,Building No.1, Poursina St. ,Ghods St. , Enghelab St , Tehran
City
Tehran
Province
Tehran
Postal code
1417613151
Approval date
2021-11-16, 1400/08/25
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1400.940
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
Social responsiveness score in SRS-2 questionnaire
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.
Category
Treatment - Drugs
2
Description
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.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Roozbeh hospital
Full name of responsible person
Alaghband rad Javad
Street address
Roozbeh hospital., South Karegar St., Tehran town
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 9151
Email
dralaghbandrad@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Fotouhi Akbar
Street address
Vice Chancellor for Research and Technology, 6th floor, Central University Organization, corner of Qods St, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3685
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
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
Tehran University of Medical Sciences
Full name of responsible person
Chohedri Elnaz
Position
Assistant of Child and adolescent psychiatry of Tehran University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Department of child and adolescent psychiatry., Roozbeh hospital., South Karegar St., Tehran
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 9151
Email
elnaz_chohedri@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Alaghband rad Javad
Position
Associate professor of child and adolescent psychiatry
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Department of child and adolescent psychiatry., Roozbeh hospital., South Karegar St., Tehran
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 9151
Email
dralaghbandrad@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Chohedri Elnaz
Position
Assistant fellow of child and adolescent psychiatry of Tehran university of Medical sciences
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Department of child and adolescent psychiatry., Roozbeh hospital., South Karegar St., Tehran
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 9151
Email
elnaz_chohedri@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not 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