A comparative study on the effectiveness of Risperidone versus Risperidone plus naltrexone in treatment of autistic spectrum disorder in children with 6-12 years old
The goal of study is comparison between Risperidon & Risperidon plus naltrexone in treatment of autistic children with 4-12 years old. The study is a cross over clinical trial that is performed double blindly on 30 patients that refer to Ibn-e-sina hospital. Inclusion criteria are age between 4-12 years old and autistic spectrum disorder and exclusion criterion is having severe medical disorders. CARS questionnaire is filled before treatment, then patients are randomly divided to two groups; one group takes risperidone alone & another group takes risperidone + naltrexone for 8 weeks. CARS are filled in weeks 0, 4, 8 to fallow symptoms. During 2 weeks of washout period, each 2 group take risperidone only and fill CARS, after that naltrexone is added to the first group and risperidone is continued for second group. CARS is filled after crossover in weeks 4, 8. Finally the result of CARS will be compared between 2 groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201108155280N5
Registration date:2013-02-10, 1391/11/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-02-10, 1391/11/22
Registrant information
Name
Raheleh Nejati
Name of organization / entity
Mashhad University of Medical Scinces, Ibn-e- Sina Psychiatric Hospital
Country
Iran (Islamic Republic of)
Phone
+98 51 3711 2540
Email address
nejatir2@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2011-09-11, 1390/06/20
Expected recruitment end date
2013-06-10, 1392/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study on the effectiveness of Risperidone versus Risperidone plus naltrexone in treatment of autistic spectrum disorder in children with 6-12 years old
Public title
A comparative study on the effectiveness of Risperidone versus Risperidone plus naltrexone in treatment of autistic spectrum disorder in children with 6-12 years old
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1- children with 4-12 years old; 2- children with at least one of the autistic spectrum disorder signs; 3- Fill out informative consent sheet in order to include the study. Exclusion criteria: 1- Children with severe medical disorders; 2- The history of severe drug sensitivity to naltrexone or risperidone.
Age
From 4 years old to 12 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
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Ghoreishi Building, Daneshgah Street
City
Mashhad
Postal code
Approval date
2011-04-30, 1390/02/10
Ethics committee reference number
89548
Health conditions studied
1
Description of health condition studied
Autistic Disorder
ICD-10 code
F84.0
ICD-10 code description
Childhood autism
Primary outcomes
1
Description
autism
Timepoint
weeks 0,4,8,10,14,18
Method of measurement
CARS
Secondary outcomes
empty
Intervention groups
1
Description
0.5 to 2mg per day risperidone tablet for 18 week.
Category
Treatment - Drugs
2
Description
naltrexone capsule (25mg) in dosage of 0.5 to 1.5 mg per kg per day for 8 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
specialty clinic for children at Ibn-e-Sina psychiatric Hospital
Full name of responsible person
Dr fatemeh Moharrari
Street address
City
Mashhad
2
Recruitment center
Name of recruitment center
specialty clinic for children at Dr Sheykh hospital
Full name of responsible person
Dr Ebrahim Abdollahian
Street address
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Scinces
Full name of responsible person
Marjan Ardakanian
Street address
Daneshgah Street, Ghoreishi Building
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Scinces
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 scinces, Ibn-e-sina hospital
Full name of responsible person
Dr Fatemeh Moharari
Position
Assistant Professor, Child and Adolescent Psychiatrist, Head of Ibn-e-Sina Hospital & Hejazi Hosoita