(1) Objectives: Assessment he efficacy of augmentation Donepezil to risperidon in treatment of autism spectrum disorders. (2) Participants including major eligibility criteria: Eligible patients after gaining the consent of a parent or legal guardian patients will be enrolled. Patients who had organic disease, patients have been treated with other psychotropic drugs and also patients with other psychiatric disorders are excluded (3 ) Autism spectrum disorders 6-17 years old , The samples were randomly divided into two groups of 33 persons.(4) Intervention: Both groups were treated with Risperidone prior to entering the study, first group is treated with placebo and the second group is treated with Donepezil , Patients at weeks zero, six, towelve in terms of therapeutic effects and adverse drug reactions are evaluated. Results of the study will be assessed by CARS and check list of drugs side effects (5) Main outcome measures (variables): Severity of Autism
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017041333406N1
Registration date:2017-09-20, 1396/06/29
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-09-20, 1396/06/29
Registrant information
Name
Neda Ghanei
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3711 2721
Email address
ghanein931@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Mashhad University of Medical Sciences
Expected recruitment start date
2017-07-06, 1396/04/15
Expected recruitment end date
2017-10-07, 1396/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment the efficacy of augmentation donepezil to risperidon in treatment of autism spectrum disorders
Public title
The efficacy of augmentation Donepezil to risperidon in treatment of autism spectrum disorders
Purpose
Treatment
Inclusion/Exclusion criteria
The inclusion criteria: Of all patients with ASD, ranging in age from 6 to 17years; Parent's Consent; No obvious organic disease; The lack of other psychiatric disorders; Not taking other psychoactive medications other than risperidone; IQ higher than 50 on the basis of Weiland test. The exclusion criteria: In the absence of cooperation of parents after inclusion; the risk of any side effect or another disease that cause a problem in results.
Age
From 6 years old to 17 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee of Mashhad University of Medical Sciences
Street address
Qoreishi Building, Daneshgah St
City
Mashhad
Postal code
1394491388
Approval date
2016-01-20, 1394/10/30
Ethics committee reference number
IR.MUMS.fm.REC.1394.529
Health conditions studied
1
Description of health condition studied
Autism Spectrum Disorders
ICD-10 code
F84
ICD-10 code description
Pervasive developmental disorders
Primary outcomes
1
Description
Response to treatment
Timepoint
Previous the syudy, 6 weeks after study, 12 weeks after study
Method of measurement
CARS test
2
Description
Severity of Autism
Timepoint
Previous the syudy, 6 weeks after study, 12 weeks after study.
Method of measurement
CARS test
Secondary outcomes
1
Description
Drug's side effect
Timepoint
Previous the study, 6weeks after study, 12weeks after study
Method of measurement
Check list
Intervention groups
1
Description
The intervention group have been treated with risperidone(maximum dose 2 mg) is also treated with placebo. The duration of intervention is 12 weeks.
Category
Placebo
2
Description
The intervention group have been treated with risperidone (maximum dose 2mg ), is also treated with Donepezil . Dosing and titration of the drug individually, but the initial dose of Donepezil is2.5 mg and the maximum dosage is 10mg,(PO) and the duration of intervention is 12weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Outpatient Clinic
Full name of responsible person
Dr Neda Ghanei
Street address
Hore ameli boulevard-Ibne Sina Hospital
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Mashhad University of Medical Sciences
Full name of responsible person
Dr Mahyar Mirheydari
Street address
Qoreishi Building, Daneshgah St
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research of Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Siences
Full name of responsible person
Dr Neda Ghanei
Position
Psychiatric Resident
Other areas of specialty/work
Street address
Hore ameli boulevard_Ibn e Sina Hospital
City
Mashhad
Postal code
Phone
+98 51 3711 2721
Fax
Email
ghanein931@mums.ac.irneda_ghanei@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
dr Fateme Behdani
Position
Professor
Other areas of specialty/work
Street address
Hore ameli boulverad- ibne sina Hospital
City
Mashhad
Postal code
Phone
+98 51 3711 2722
Fax
Email
behdanif@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Neda Ghanei
Position
Psychiatric Resident
Other areas of specialty/work
Street address
Hore ameli boulevard-Ibn e Sina Hospital
City
Mashhad
Postal code
Phone
+98 51 3711 2722
Fax
Email
ghanein931@mums.ac.irneda_ghanei@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)