Protocol summary

Summary
This is an eight-week randomized controlled parallel group clinical trial to compare the efficacy of daily taking aripiprazole versus twice-weekly aripiprazole for treating 40 children and adolescents with tic disorder. Assessment using Yale global tic severity scale is used to measure tic severity at pre-intervention, and 4 and 8 weeks after starting the medication interventions.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201312263930N32
Registration date: 2014-08-03, 1393/05/12
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-08-03, 1393/05/12
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
2014-01-13, 1392/10/23
Expected recruitment end date
2014-09-14, 1393/06/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Twice-weekly aripiprazole for treating children and adolescents with tic disorder, a randomized controlled clinical trial
Public title
Twice-weekly aripiprazole for treating children and adolescents with tic disorder, a randomized controlled clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: children and adolescents aged 5 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 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not 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
Hafez Hospital
City
Shiraz
Postal code
--
Approval date
2014-01-12, 1392/10/22
Ethics committee reference number
CT-92-6631

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
tic severity
Timepoint
Every 4 weeks
Method of measurement
Yale global tic severity scale

Secondary outcomes

empty

Intervention groups

1

Description
aripiprazole up to 10 mg/day every day
Category
Treatment - Drugs

2

Description
aripiprazole up to 10 mg/day every two times per week
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Research Center for Psychiatry and Behavioral 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
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 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 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

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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