This randomized double blind clinical trial examines the adjuvant effect of acid folic for treating irritability in children with autism. 40 children will be randomly allocated into treatment group or placebo group. Both groups will receive risperidone for 8 weeks. Outcome will be assessed using Aberrant Behavior Checklist.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201402043930N33
Registration date:2014-08-16, 1393/05/25
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-08-16, 1393/05/25
Registrant information
Name
Ahmad Ghanizadeh
Name of organization / entity
Research Center for Psychiatry and Behavioral Sciences, Shiraz University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1627 3070
Email address
ghanizad@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sceinces
Expected recruitment start date
2014-02-03, 1392/11/14
Expected recruitment end date
2015-02-03, 1393/11/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Double blind randomized controlled clinical trial of the effect of short-term co-administration of acid folic on children and adolescents with autism
Public title
short-term co-administration of acid folicfor treating children and adolescents with autism
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Autism according to DSM-IV diagnostic criteria; aged 3 to 19 years old.
Exclusion Criteria: primary diagnosis of a psychotic disorder; active substance abuse or dependence; unstable medical condition.
Age
From 3 years old to 19 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
40
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
Ethics Committee of Shiraz University of Medical Sceinces
Street address
Shiraz University of Medical Sceinces
City
Shiraz
Postal code
--
Approval date
2014-02-02, 1392/11/13
Ethics committee reference number
CT-92-6478
Health conditions studied
1
Description of health condition studied
Pervasive developmental disorders
ICD-10 code
F84.0
ICD-10 code description
Childhood autism
Primary outcomes
1
Description
irritability
Timepoint
Every 4 weeks
Method of measurement
Abbrant Behavior Checklist
Secondary outcomes
1
Description
Adverse effects
Timepoint
Week 2, 4, and 8
Method of measurement
checklist
Intervention groups
1
Description
Acid folic (5mg/day)+ risperidone (0.5 to 3 mg/day)
Category
Treatment - Drugs
2
Description
Placebo + risperidone (0.5 to 3 mg/day)
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Research Center for Psychiatry and Behavioral Sciences, Shiraz University of Medical Sciences
Full name of responsible person
Ahmad Ghanizadeh
Street address
Hafez Hospital
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shiraz University of Medical sciences
Full name of responsible person
Basi Hasemi
Street address
Shiraz University of Medical Sciences
City
Fars
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, Shiraz 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
Shiraz University of Medical sciences
Full name of responsible person
Parisa Ansarifar
Position
Student of Medicine
Other areas of specialty/work
Street address
Hafez Hospita
City
Shiraz
Postal code
--
Phone
+98 71 1627 3070
Fax
Email
Ansarifar_p@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical sciences
Full name of responsible person
Ahmad Ghanizadeh
Position
Professor of Psychiatry
Other areas of specialty/work
Street address
Hafez Hospital
City
Shiraz
Postal code
--
Phone
+98 71 1627 3070
Fax
Email
ghanizad@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz Univerity of Medical Sciences
Full name of responsible person
Parisa Ansarifar
Position
Student of Medicine
Other areas of specialty/work
Street address
Zand Street
City
Shiraz
Postal code
Phone
+98 71 1627 3070
Fax
Email
ansarifar_p@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)