The objective of this study is to assess the efficacy of Resveratrol in the treatment of autism
Design
Randomized double blind and placebo-controlled clinical trial
Settings and conduct
The study will be conducted among children with autistic disorder attending Roozbeh Hospital
Participants/Inclusion and exclusion criteria
Inclusion criteria: DSM-5 clinical diagnosis of autistic disorder children between the ages of 3 and 12 years presence of behavioral problems such as aggression, overactivity or repetitive behaviors (indication of treatment with risperidone)
Exlusion criteria:Presence of any active medical problem other psychiatric diagnosis except for mild to moderate Intellectual disability receiving any antipsychotic medications during past monthprior to the trial severe hepatic disease history of allergy to risperidone and intolerance of it History of seizure requiring change of antiepileptic dose during the last month seizure during the last 6 months
Intervention groups
The participants will be randomly allocated into two groups. Intervention group(25 persons) will receiveResveratrol (500 mg/day) and risperidone ( 1 to 3.5 mg per day) and control group( 25 persons) will receive risperidone( 1 to 3.5 mg per day) for 12 weeks.
Main outcome variables
severity of autism
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090117001556N104
Registration date:2017-12-25, 1396/10/04
Registration timing:prospective
Last update:2017-12-25, 1396/10/04
Update count:0
Registration date
2017-12-25, 1396/10/04
Registrant information
Name
Shahin Akhondzadeh
Name of organization / entity
Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5541 2222
Email address
s.akhond@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-08, 1396/10/18
Expected recruitment end date
2020-01-08, 1398/10/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Resveratrol add on therapy to risperidone in irritibility of children with autism: a randomized double-blind placebo-controlled clinical trial
Public title
Resveratrol in treatment of autism
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
DSM-5 clinical diagnosis of autistic disorder
children between the ages of 3 and 12 years
presence of behavioral problems such as aggression, overactivity or repetitive behaviors (indication of treatment with risperidone)
Exclusion criteria:
Presence of any active medical problem
other psychiatric diagnosis except for mild to moderate Intellectual disability
receiving any antipsychotic medications during past monthprior to the trial
severe hepatic disease
history of allergy to risperidone and intolerance of it
History of seizure requiring change of antiepileptic dose during the last month
seizure during the last 6 months
Age
From 3 years old to 12 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Random permuted block
Blinding (investigator's opinion)
Double blinded
Blinding description
The participants, clinicians and outcome raters will be blind regarding grouping
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Keshavarz Blv
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2018-01-08, 1396/10/18
Ethics committee reference number
IR.TUMS.VCR.REC.1396.4173
Health conditions studied
1
Description of health condition studied
autistic disorder
ICD-10 code
F84.0
ICD-10 code description
Autistic disorder
Primary outcomes
1
Description
Severity of autism
Timepoint
Baseline and weeks 4, 8 and 12
Method of measurement
By Aberrant Behavior Checklist-Community( ABC-C) and Childhood Autism Rating scale( CARS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Tablet Resveratrol( 500 mg per day) plus Risperidone ( 1 to 3.5 mg per day) for 12 weeks
Category
Treatment - Drugs
2
Description
Control group: Tablet placebo plus Risperidone( 1 to 3.5 mg per day) for 12 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Roozbeh Hospital
Full name of responsible person
Prof. M.R. Mohammadi
Street address
Roozbeh Hospital
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 2222
Fax
+98 21 5541 2756
Email
mohammadimr@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Ali Sahraian
Street address
Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8898 7381
Email
msahrai@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
Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences
Full name of responsible person
Shahin Akhondzadeh
Position
Professor of clinical psychopharmacology
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Roozbeh Hospital, South Kargar Street, Tehran
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 2222
Fax
+98 21 5541 9113
Email
s.akhond@sina.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shahin Akhondzadeh
Position
Professor of clinical psychopharmacology
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Roozbeh Hospital, South Kargar Street, Tehran
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 2222
Fax
+98 21 5541 9113
Email
s.akhond@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shahin Akhondzadeh
Position
Professor of clinical psychopharmacology
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Roozbeh Hospital, South Kargar Street, Tehran
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 2222
Fax
+98 21 5541 9113
Email
s.akhond@sina.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The data will be distributed through final report
When the data will become available and for how long
5 years from 2020 to 2025
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
En by citing the resourse
From where data/document is obtainable
Professor Shahin Akhondzadeh
What processes are involved for a request to access data/document