Effect of Repetitive Transcranial Magnetic Stimulation approved by FDA (rTMS-FDA) versus Repetitive Transcranial Magnetic Stimulation with concentration on Mirror Neuron System (rTMS-MNS) on emotion and mood regulation in patients with major depressive disorder: a randomized clinical trial
Objectives: To assess the effect of rTMS-FDA versus rTMS-MNS on emotion and mood regulation in patients with major depressive disorder
Design: a randomized clinical trial.
Setting and conduct: The eligible patients with major depressive disorder who will refer to Farshchian Hospital during the study period will be enrolled into the trial.
Inclusion criteria: major depressive disorder; age of 18 to 65 years; receiving standard anti-depression drugs.
Exclusion criteria: pregnancy; drug abuse during the last month; drug addiction during the last six months; neurologic disease or convulsion; having metal implant; using lorazepam, benzodiazepines, monoamine oxidase enzyme inhibitors or bupropion in the last month.
Intervention group: Transcranial Magnetic Stimulation approved by FDA for 30 minutes 5 times a week for 2 consecutive weeks.
Control group: Transcranial Magnetic Stimulation with concentration on Mirror Neuron System for 30 minutes 5 times a week for 2 consecutive weeks.
Primary outcome: (a) assessing excitement regulation before and 2 and 4 weeks after intervention using excitement adequacy ranking scale; (b) assessing mood regulation before and 2 and 4 weeks after intervention using POMS criteria; (c) assessing social perception before and 2 and 4 weeks after intervention by reading mind in the eyes.
Randomization: The patients will be randomly assigned to intervention and control groups using block randomization.
Blinding: Not blind.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201610209014N123
Registration date:2016-10-29, 1395/08/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-10-29, 1395/08/08
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2016-07-22, 1395/05/01
Expected recruitment end date
2017-01-30, 1395/11/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Repetitive Transcranial Magnetic Stimulation approved by FDA (rTMS-FDA) versus Repetitive Transcranial Magnetic Stimulation with concentration on Mirror Neuron System (rTMS-MNS) on emotion and mood regulation in patients with major depressive disorder: a randomized clinical trial
Public title
Effect of Repetitive Transcranial Magnetic Stimulation approved by FDA (rTMS-FDA) versus Repetitive Transcranial Magnetic Stimulation with concentration on Mirror Neuron System (rTMS-MNS) on emotion and mood regulation in patients with major depressive disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: major depressive disorder; age of 18 to 65 years; receiving standard anti-depression drugs.
Exclusion criteria: pregnancy; drug abuse during the last month; drug addiction during the last six months; neurologic disease or convulsion; having metal implant; using lorazepam, benzodiazepines, monoamine oxidase enzyme inhibitors or bupropion in the last month.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization: The patients will be randomly assigned to intervention and control groups using block randomization.
Blinding: Not blind.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Approval date
2016-09-25, 1395/07/04
Ethics committee reference number
IR.UMSHA.REC.1395.294
Health conditions studied
1
Description of health condition studied
Major depression
ICD-10 code
F32.3
ICD-10 code description
Severe depressive episode with psychotic symptoms
Primary outcomes
1
Description
assessing excitement regulation
Timepoint
before and 2 and 4 weeks after intervention
Method of measurement
using excitement adequacy ranking scale
2
Description
assessing mood regulation
Timepoint
before and 2 and 4 weeks after intervention
Method of measurement
using POMS criteria
3
Description
assessing social perception
Timepoint
before and 2 and 4 weeks after intervention
Method of measurement
by reading mind in the eyes
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Transcranial Magnetic Stimulation approved by FDA for 30 minutes 5 times a week for 2 consecutive weeks.
Category
Treatment - Other
2
Description
Control group: Transcranial Magnetic Stimulation with concentration on Mirror Neuron System for 30 minutes 5 times a week for 2 consecutive weeks.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Farshchian Hospital
Full name of responsible person
Mojtaba Taiebi
Street address
Farshchian Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
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 the Technology, Hamadan 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
Farshchian Hospital
Full name of responsible person
Mojtaba Taiebi
Position
Medical Student
Other areas of specialty/work
Street address
Farshchian Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Postal code
Phone
+98 81 3827 4184
Fax
Email
tayebi.ir@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Farshchian Hospital
Full name of responsible person
Dr Mohammad Haghigi
Position
Psychologist
Other areas of specialty/work
Street address
Farshchian Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Postal code
Phone
+98 81 3827 4184
Fax
Email
haghighi@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Epidemiology
Full name of responsible person
Dr Jalal Poorolajal
Position
Associate Professor
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Fax
Email
poorolajal@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)