This is a 8-week, double blind, controlled clinical trial including 60 children and adolescents with tic disorder. They will be randomly allocated into one of the two groups of risperidone (0.5 to 3 mg/day) or aripiprazole (2 to 10 mg/day). DSM-IV diagnostic criteria are used to make diagnosis. YGTS and Clinical Global Impression-Severity will be used to rate the efficacy of treatment. Adverse effects are assessed using a checklist. Those with a sever medical condition are not included.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201301053930N17
Registration date:2013-02-08, 1391/11/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-02-08, 1391/11/20
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 Sciences
Expected recruitment start date
2012-08-31, 1391/06/10
Expected recruitment end date
2013-09-01, 1392/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Aripiprazole versus risperidone in the treatment of children and adolescents with tic disorders, a double blind randomized controlled clinical trial
Public title
Aripiprazole versus risperidone in the treatment of children and adolescents with tic disorders
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: children and adolescents aged 6 to 18 years; total score of YGTS more than 21. Exclusion criteria: Marked general medical condition; hypersensitivity to the medications.
Age
From 5 years old to 19 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sceinces
Street address
Hafez Hospital
City
Shiraz
Postal code
--
Approval date
2012-08-30, 1391/06/09
Ethics committee reference number
CT-91-3228
Health conditions studied
1
Description of health condition studied
Tic disorder
ICD-10 code
F95
ICD-10 code description
Tic disorders
Primary outcomes
1
Description
Yale global tic severity scale
Timepoint
Every 4 weeks
Method of measurement
interview
Secondary outcomes
1
Description
Adverse effects checklist
Timepoint
every 4 weeks
Method of measurement
checklist
Intervention groups
1
Description
Risperidone up to 3 mg/day
Category
Treatment - Drugs
2
Description
Aripiprazole up to 10 mg/day
Category
Treatment - Drugs
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
Gholam Reza Hatam
Street address
Vice-chancellery of Research Affairs, Shiraz University of Medical sciences, Zand Street
City
Shiraz
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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical sciences
Full name of responsible person
Ahmad Ghanizadeh
Position
MD
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
Sharing plan
Deidentified Individual Participant Data Set (IPD)