A clinical trial with two parallel intervention groups, without blinding, randomized, phase 2 on 32 patients. A table of random numbers was used for randomization.
Settings and conduct
This study will be conducted in 1402 in the city of Isfahan in the population of children with chronic tic disorder. The participants will be placed in one of the two treatment groups of topiramate or haloperidol. Blinding will not be done in this study.
Participants/Inclusion and exclusion criteria
This study is conducted on children aged 6 to 12 years who have the informed consent of their parents to participate in the study and do not have any other psychiatric disorder or history of any other disease.
Intervention groups
Children in this study are treated in two groups. The first group was treated with haloperidol at a dose of 0.225 to 8 mg per day and the second group was treated with topiramate at a dose of 50 to 200 mg per day.
Main outcome variables
tic
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230803059021N1
Registration date:2023-08-10, 1402/05/19
Registration timing:prospective
Last update:2023-08-10, 1402/05/19
Update count:0
Registration date
2023-08-10, 1402/05/19
Registrant information
Name
Fahime Rezaie
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 913 328 9507
Email address
rezaeedr022@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-23, 1402/06/01
Expected recruitment end date
2023-09-23, 1402/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of topiramate treatment with haloperidol in chronic tic disorder
Public title
topiramate treatment with haloperidol in chronic tic disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
parental informed consent
DSM-V criteria for chronic tic disorder
age between 6 and 12
Exclusion criteria:
Presence of major medical disorders such as epilepsy, diabetes, heart and kidney diseases
mental retardation
Hypersensitivity to topiramate and haloperidol
The presence of concomitant psychiatric disorders that require drug intervention
History of long QT syndrome, cardiac arrhythmia, kidney stones and concurrent use of carbonic anhydrase inhibitor drugs
Age
From 6 years old to 12 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
First, with the help of a random number table, a number of random numbers were generated according to the sample size, and then they were placed in sealed envelopes in this order and numbered on the envelopes. Then, according to the order in which the participants entered the study, an envelope is opened and a random sequence is determined.
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 Isfahan University of Medical Sciences
Street address
Hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
8974673461
Approval date
2023-04-29, 1402/02/09
Ethics committee reference number
IR.MuI.MED.REC.1402.059
Health conditions studied
1
Description of health condition studied
chronic tic disorder
ICD-10 code
F95.1
ICD-10 code description
Chronic motor or vocal tic disorder
Primary outcomes
1
Description
tic
Timepoint
before treatment and 1 month after and 2 month after
Method of measurement
Yale Global Tic Severity scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Treatment with haloperidol manufactured by Subhan Daru company in the form of 0.25 to 8 mg daily for 2 months
Category
Treatment - Drugs
2
Description
Intervention group: Treatment with topiramate drug manufactured by Elixir Danesh company in the form of 50 to 200 mg daily for 2 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amin hospital
Full name of responsible person
Fahime Rezaie
Street address
Hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
8974673461
Phone
+98 913 328 9507
Email
rezaeedr022@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Asgari
Street address
Hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
8974673461
Phone
+98 31 3668 8138
Email
askari@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Faime Rezaie
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
8974673461
Phone
+98 31 3668 8138
Email
rezaeedr022@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Fahime Rezaie
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
8974673461
Phone
+98 31 3668 8138
Email
rezaeedr022@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Fahime Rezaie
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
8974673461
Phone
+98 31 3668 8138
Email
rezaeedr022@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD