evaluation of the effect dual combination of Donepezil and Betahistine in improving the symptoms of autism spectrum disorder
- Conditions
- F84.0Autism Spectrum Disorder.Autistic disorder
- Registration Number
- IRCT20160905029714N2
- Lead Sponsor
- Tehran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 30
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
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.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method PedsQL total score. Timepoint: Week 0, week 5 , week 10. Method of measurement: PedsQL questionnaire parent form.