Effectiveness of Repetitive Transcranial Magnetic Stimulation ( rTMS ) add-on therapy to Standard treatment in Major Depressive Disorder Patients with sexual dysfunction in Sina Farshchian Hospital in Hamadan city
Effectiveness of Repetitive Transcranial Magnetic Stimulation ( rTMS ) add-on therapy to Standard treatment in Major Depressive Disorder Patients with sexual dysfunction in Sina Farshchian Hospital in Hamadan city
Design
This is a single blind randomized clinical trial, in which 40 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
This study is performed in Farshchian Hospital in Hamadan. Patients with major depression and sexual dysfunction are included in the study. Patients are unaware of group assignment, so a single blinded study is performed. Patients receive 10-minute direct current electrical stimulation of the brain with a current of 2 mA and in the control group receive 10 inactive 20-minute sessions with the same device.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Consent to participate in the study; Patient with major depression (Montgomery-Asberg Depression Scale greater than 20); Not receive repeated transcranial magnetic stimulation and electro convulsive therapy in the past two months; Married men and women between 18 and 60 years old; Having sexual dysfunction
Exclusion criteria: Patients at risk of suicide; Patients with other psychiatric disorders such as bipolar disorde; psychosis;schizophrenia.
Intervention groups
20 patients with major depression and sexual dysfunction receive 10 sessions of 20 minutes with 2 mA direct current and 10 sessions of 20 minutes passive with the same device in the control group.
Main outcome variables
The score of Montogomerie-Asberg Depression Inventory, Hamilton Depression Scale, sexual function and cognitive function are compared in the intervention and control groups before the intervention and after the tenth session.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160523028008N15
Registration date:2021-06-08, 1400/03/18
Registration timing:prospective
Last update:2021-06-08, 1400/03/18
Update count:0
Registration date
2021-06-08, 1400/03/18
Registrant information
Name
Mohammad Faryadras
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3428 9706
Email address
m.faryadras@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-23, 1400/06/01
Expected recruitment end date
2022-03-16, 1400/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of Repetitive Transcranial Magnetic Stimulation ( rTMS ) add-on therapy to Standard treatment in Major Depressive Disorder Patients with sexual dysfunction in Sina Farshchian Hospital in Hamadan city
Public title
Effectiveness of Repetitive Transcranial Magnetic Stimulation ( rTMS ) add-on therapy to Standard treatment in Major Depressive Disorder Patients with sexual dysfunction.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Consent to participate in the study.
Patient with major depression (Montgomery-Asberg Depression Scale greater than 20)
Not receive repeated transcranial magnetic stimulation and electroconvulsive therapy in the past two months
Married men and women are sexually active and married between 18 and 60 years old
Having sexual dysfunction
Exclusion criteria:
Patients at risk of suicide
Patients with other psychiatric disorders such as bipolar disorder, psychosis, schizophrenia
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare four sheets of paper, writing on two sheets the name of the intervention and on the other two sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all four sheets are drawn. The four paper sheets will be then placed back into the container, and this action repeated until the sample size is reached.
Blinding (investigator's opinion)
Single blinded
Blinding description
For patient's in sham group, we used the same coil in active group but we placed it perpendicular to patient's scalp, therefore we were able to reproduce the somatic vibration sensation and acoustic artifact without stimulating motor cortex. As patients would receive intervention in separate appointments and there was no contact between patients, apart from the operator of rTMS. Therefore, the trial will be run as single blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethic Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2021-05-01, 1400/02/11
Ethics committee reference number
IR.UMSHA.REC.1400.100
Health conditions studied
1
Description of health condition studied
Major depressive episode
ICD-10 code
F32
ICD-10 code description
Major depressive episode
Primary outcomes
1
Description
Depression
Timepoint
Before and after 10 sessions of intervention.
Method of measurement
Montgomery-Sberg Depression Scale and Hamilton Depression Inventory
2
Description
Sexual function
Timepoint
Before and after 10 sessions of intervention.
Method of measurement
Female Sexual Function Questionnaire and Arizona Sexual Experience Scale
Secondary outcomes
1
Description
Cognitive Assessment
Timepoint
Before and after 10 sessions of intervention.
Method of measurement
Montreal Cognitive Function Questionnaire
Intervention groups
1
Description
Intervention group: 10 session of 20 minute of trans cranial direct current stimulation by 2 ma
Category
Treatment - Other
2
Description
Control group:10 sessions of 20 minutes with the same device that is inactive.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Farshchian Hospital
Full name of responsible person
Amir Keshavarzi
Street address
Farshchian Hospital, Mirzadeh Eshghi Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 1828 5015
Email
drkeshavarzi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Amir Keshavarzi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Farshchian Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81182851015
Email
drkeshavarzi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Amir Keshavarzi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Farshchian Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81182851015
Email
drkeshavarzi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Amir Keshavarzi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Farshchian Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81182851015
Email
drkeshavarzi@yahoo.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