Comparison of treatment with Repetitive Trans cranial Magnetic Stimulation with medication, with medication alone in obsessive-compulsive disordered resistance to medication
Comparison of treatment with Repetitive Trans cranial Magnetic Stimulation with medication, with medication alone in obsessive-compulsive disordered
Design
Study was performed as a triple blind clinical trial on all patients with OCD with incidence criteria. At first, patients completed the Yale Brown YBOCS questionnaire. Patients with a score of 16 or older and without depression are enrolled in the study.
A total of 30 patients are selected and are assigned to one of two groups, A or B, by randomized block design. Group A receive simultaneously with drug therapy for 3 weeks and 5 times per week with a frequency of 1 Hz for 20 minutes (1200 pulses / day) and patients in Group B are treated with drugs, but SHAM is used for them, that is, a device with no magnetic stimulation on the head.
At the end of each week, patients again fill out the YBOCS questionnaire. At the end of the study, the mean scores of the questionnaire, as well as the clinical observations and clinical assessments of the questioner, were compared in both groups compared to the beginning of the study and the other group in order to determine the effectiveness of each regimen independently and in comparison with others as well as the rate of remission.
Settings and conduct
A triple blind clinical trial on all patients with OCD
Participants/Inclusion and exclusion criteria
Inclusion criteria: A previous history of OCD; In the YBOCS questionnaire, the score more than or equal to 16, and in the Beck questionnaire the score was not higher than 17.
Exclusion criteria: History of seizure or epileptic seizures; History of severe head trauma or severe neurological complications.
Intervention groups
Group A: Therapeutic drug for 3 weeks and 5 times per week with a frequency of 1 Hz for 20 minutes (1200 pulses / day)
Group B: Therapeutic drug plus SHAM
Main outcome variables
Improvement
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190622043979N1
Registration date:2019-06-26, 1398/04/05
Registration timing:prospective
Last update:2019-06-26, 1398/04/05
Update count:0
Registration date
2019-06-26, 1398/04/05
Registrant information
Name
Alireza Haj Seyed Javadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3333 5800
Email address
ahsjavadi@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-22, 1398/04/31
Expected recruitment end date
2020-03-18, 1398/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of treatment with Repetitive Trans cranial Magnetic Stimulation with medication, with medication alone in obsessive-compulsive disordered resistance to medication
Public title
Comparison of treatment with Repetitive Trans cranial Magnetic Stimulation with medication, with medication alone in obsessive-compulsive disordered
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18-60
A previous history of OCD for at least one year, treated with the first two Obsessive drugs approved by the FDA, has not been improved and is right-handed.
In the YBOCS questionnaire, the score was more than or equal to 16, and in the Beck questionnaire the score was not higher than 17.
Exclusion criteria:
Accompanied with other psychiatric disorders
History of seizure or epileptic seizures
Beck questionnaire score above 17
Pregnancy
Substance abuse based on biographie
History of severe head trauma or severe neurological complications
Metal implant or pace maker
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization is done using block method. Unit of randomization is individual. Randomization is done using a table of random numbers and to generate random sequences as online, computer is used. For concealing treatment allocation, the list of treatments are placed in the enclosed and numbered (to maintain order of sequences) envelopes .
Blinding (investigator's opinion)
Triple blinded
Blinding description
This study is triple blind, and each patients receive a code, whether RTMS or SHAM is done by one of the nurses. Main contributors to the project, and the patients and the one who finally analyzes the results, all of them are not aware of patients assignment to groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Qazvin University of Medical Sciences
Street address
Shahid Bahonar Blvd., Qazvin
City
Qazvin
Province
Qazvin
Postal code
3419759811
Approval date
2019-02-20, 1397/12/01
Ethics committee reference number
IR.QUMS.REC.1397.357
Health conditions studied
1
Description of health condition studied
Obsessive compulsive disorder resistance to drug therapy
ICD-10 code
F42
ICD-10 code description
Obsessive-compulsive disorder
Primary outcomes
1
Description
Improvement
Timepoint
Obsessive compulsive disorder will be assessed in both groups of A and B after 3 weeks.
Method of measurement
At the end of the study, the mean scores of the questionnaire, as well as the clinical observations and clinical assessments of the questioner, were compared in both groups compared to the beginning of the study and the other group in order to determine the effectiveness of each regimen independently and in comparison with others as well as the rate of remission
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Therapeutic drug for 3 weeks and 5 times per week with a frequency of 1 Hz for 20 minutes (1200 pulses / day)
Category
Treatment - Drugs
2
Description
Control group: Therapeutic drug plus SHAM (placement of the device without magnetic stimulation on the head)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
22 Bahman Hospital
Full name of responsible person
Ghazal Jahanbakhsh
Street address
Rah ahan street, Qazvin
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3356 5712
Email
dralihsj52@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr Amir Peymani
Street address
Shahid Bahonar Blvd., Qazvin
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3356 5712
Email
dralihsj52@gmail.com
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
Ghazal Jahan Bakhsh
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Rah ahan street, Qazvin
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3356 5712
Email
dralihsj52@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Alireza Haj Seyed Javadi
Position
Associate
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Rah ahan street, Qazvin
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3356 5712
Email
dralihsj52@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Ghazal Jahan Bakhsh
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Rah ahan street, Qazvin
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3356 5712
Email
dralihsj52@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
There is no further information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available