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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20160905029714N2

Enrollment

Registered

2022-03-08

Start date

2022-02-20

Completion date

Unknown

Last updated

2022-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorder. Autistic disorder

Interventions

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 th

Eligibility

Sex/Gender

All

Age

6 Years to 18 Years

Inclusion 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

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.

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
PedsQL total score. Timepoint: Week 0, week 5 , week 10. Method of measurement: PedsQL questionnaire parent form.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactChohedri Elnaz

Tehran University of Medical Sciences

elnaz_chohedri@yahoo.com+98 21 5541 9151

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026