Therapeutic effect comparison of the Repetitive Transcranial Magnetice Stimulation (RTMS) combination therapy with drug versus medication monotherapy in obsessive compulsive disorder (OCD)
evaluate the efficacy (rTMS) as an adjunct therapy in combination with medication and localization in Iranian patients.
Design
Two arm parallel group randomized trial with blinded
postoperative care and outcome assessment. Random
allocation will be used in this trial based on balance block
randomization and by 4:1 blocks. To do study with
concealment, table of block will be used by one of
researchers, other than interviewer and who assess
patients in follow-up visits, to write number of each
participants on box of additional drugs. Therefore, all of
patients, interviewer and who assess patients in follow-
up visits will be unaware if each number belongs to
which groups.
Settings and conduct
Patients with a history of OCD who referred to the 22-Bahman Hospital's Psychiatric Clinic were interviewed by a psychiatrist who had DSM5 diagnostic criteria for obsessive-compulsive disorder
Participants/Inclusion and exclusion criteria
age 18-60 years History of moderate to severe persistent OCD
The subjects did not score above 17 according to the Beck Depression questionaaire
Exclusion criteria
association with other psychiatric illnesses,
history of epilepsy
history of drug abuse
history of neurosurgery complications
having any type of metal implant
Intervention groups
Group A was treated with(rTMS) for 5 days (5,200 pulses / day) for 3 weeks at the same time as taking the drug While patients in group "B" were only treated with standard medication and sham was used for them so that the device was placed on their scalp without magnetic stimulation
Main outcome variables
Severity of obsessive-compulsive disorder
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200728048240N1
Registration date:2020-08-08, 1399/05/18
Registration timing:retrospective
Last update:2020-08-08, 1399/05/18
Update count:0
Registration date
2020-08-08, 1399/05/18
Registrant information
Name
Adeleh Askaridiarjani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3355 5054
Email address
a.askaridiarjani@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-08-23, 1396/06/01
Expected recruitment end date
2018-04-23, 1397/02/03
Actual recruitment start date
2018-05-26, 1397/03/05
Actual recruitment end date
2019-01-30, 1397/11/10
Trial completion date
2019-01-30, 1397/11/10
Scientific title
Therapeutic effect comparison of the Repetitive Transcranial Magnetice Stimulation (RTMS) combination therapy with drug versus medication monotherapy in obsessive compulsive disorder (OCD)
Public title
Effect of Repetitive Trans cranial Magnetic Stimulition (r-TMS) in treatment of obsessive-compulsive disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18-60 years
History of moderate to severe persistent OCD (score greater than or equal to 16 in the Y-BOCS questionnaire)
Score of the Beck Depression questionaaire below of 17
Receiving standard OCD medication through four weeks.
Exclusion criteria:
History of epilepsy or seizures
History of drug abuse
History of severe head trauma
Having any type of metal implant or pace maker
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
30
Actual sample size reached:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation will be used in this trial based on
balance block randomization and by 4:1 blocks. To perform randomization, participant included based on numbers of boxes which randomized based on the table one by one.
Blinding (investigator's opinion)
Triple blinded
Blinding description
To do study with concealment, table of block will be used
by one of researchers, other than interviewer and who
assess patients in follow-up visits, to write number of
each participants on box of additional drugs. Therefore,
all of patients, interviewer and who evaluates patients in
follow-up visits will be unaware if each number belongs
to which groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Qhazvin University of Medical Science
Street address
Rahahan, Ave22, Bahman Hospital
City
Qhazvin
Province
Qazvin
Postal code
3416899198
Approval date
2017-04-08, 1396/01/19
Ethics committee reference number
IR.QUMS.REC.1396.63
Health conditions studied
1
Description of health condition studied
Obsessive-compulsive diorder
ICD-10 code
F42
ICD-10 code description
Obsessive-compulsive disorder
Primary outcomes
1
Description
Severity of OCD
Timepoint
0, 1, 2, 3 weeks
Method of measurement
Yale-Brown OCS
Secondary outcomes
empty
Intervention groups
1
Description
Group A was treated with magnetic resonance imaging (rTMS) at low frequency (1 Hz) for 20 minutes daily for 5 days (5,200 pulses / day) for 3 weeks at the same time as taking the drug
Category
Treatment - Devices
2
Description
Control group:patients in group "B" were only treated with standard medication with the diagnosis of a psychiatrist and sham was used for them so that the device was placed on their scalp without magnetic stimulation
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
22 Bahman Hospital
Full name of responsible person
Adeleh Askaridiarjani
Street address
Rah ahan Ave22 bahman Hospital
City
Qhazvin
Province
Qazvin
Postal code
3416899198
Phone
+98 28 3355 0254
Email
a.askaridiarjani@qums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Mohammad Mahdi Emamjomeh
Street address
Rah ahan Ave22 bahman Hospital
City
Qhazvin
Province
Qazvin
Postal code
3416899198
Phone
Email
a.askaridiarjani@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Adeleh Askaridiarjani
Position
Psychiatrist, Department of Psychiatry, Qazvin University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Rah ahan Aven 22 Bahman Hospital
City
Qhazvin
Province
Qazvin
Postal code
3416899198
Phone
098 28 33550254
Email
a.askaridiarjani@qums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Seyed Alireza Haji Seyed Javadi
Position
Associate Professor, Psychiatrist, Department of Psychiatry, Qazvin University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Rah ahan Aven 22 Bahman Hospital
City
Qhazvin
Province
Qazvin
Postal code
3416899198
Phone
098 28 33550254
Email
a.askaridiarjani@qums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Adeleh Askaridiarjani
Position
Psychiatrist, Department of Psychiatry, Qazvin University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Rah ahan Aven 22Bahman Hospital
City
Qhazvin
Province
Qazvin
Postal code
3416899198
Phone
098 28 33550254
Email
a.askaridiarjani@qums.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
Not applicable
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Data about main outcome of study will be published
When the data will become available and for how long
2022
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
For scientific goals
From where data/document is obtainable
Dr Adele Askaridiarjani: a.askaridiarjani@qums.ac.ir
What processes are involved for a request to access data/document