Protocol summary
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Study aim
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The study of the effectiveness and repetitive transcranial magnetic stimulation (rTMS) on anhedonia, rumination and neural networks associated with each of them
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Design
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Clinical trials with control group with randomized double-blind parallel groups.
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Settings and conduct
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The study is conducted at Atieh Clinical Neuroscience Center. Participants receive treatment for 10 sessions after being assigned to the intervention group. Before starting the treatment, the participants perform the Snaith-Hamilton Pleasure Scale (SHAPS) Rumination Response scale (RRS) and the Hamilton Depression Rating Scale (HDRS) at baseline and during the tenth session for clinical evaluation. qEEG will be taken from the participants to check the anhedonia and ruminantion networks at baseline and treatment completion.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Outpatients male and female with the range of 18-70 years of age, The diagnosis of Major depressive disorder (MDD) according to Diagnostic and Statistical Manual of Mental Disorders (DSM-V), Having beck depression inventory (BDI)>14, Having stable symptoms as defined by not requiring a change in medication for at least 4 weeks, Completion of consent form,Being under supervision of a psychiatrist. exclusion criteria:The history of rTMS treatment for any reason, having cardiac pacemaker,The risk of seizure with any reasons, pregnancy,High risk of suicide,Intracranial implant and other ferromagnetic materials close to the head
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Intervention groups
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There are 2 intervention groups in this study. The first group rTMS and the second group received sham rTMS. In the control group, the stimulation parameters are similar to the actual TMS group, except that the coil angel is 90 ° and perpendicular to the head.
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Main outcome variables
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Anhedonia; Rumination,
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20100615004191N3
Registration date:
2018-02-06, 1396/11/17
Registration timing:
retrospective
Last update:
2018-05-05, 1397/02/15
Update count:
2
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Registration date
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2018-02-06, 1396/11/17
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2016-12-21, 1395/10/01
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Expected recruitment end date
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2017-06-10, 1396/03/20
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Actual recruitment start date
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2016-12-21, 1395/10/01
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Actual recruitment end date
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2017-09-21, 1396/06/30
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Trial completion date
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empty
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Scientific title
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The study of effectiveness of repetitive transcranial magnetic stimulation (rTMS) on anhedonia, rumination with their related neural circuits in patients with major depression
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Public title
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The study of effectiveness repetitive transcranial magnetic stimulation (rTMS) on anhedonia and rumination in patients with major depression
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Outpatients male and female with the range of 18-70 years of age
The diagnosis of Major depressive disorder according to DSM-V
Having BDI>14
Having stable symptoms as defined by not requiring a change in medication for at least 4 weeks
Completion of consent form
Being under supervision of a psychiatrist
Exclusion criteria:
The history of rTMS treatment for any reason
Cardiac pacemaker
The risk of seizure with any reasons
Pregnancy
High risk of suicide
Intracranial implant and other ferromagnetic materials close to the head
co-morbidity with disorders in axis I and II
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Age
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From 18 years old to 70 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Outcome assessor
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Sample size
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Target sample size:
60
Actual sample size reached:
58
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Random allocation software was used for random sequence generation. The random allocation process was carried out by a researcher blinded to the random sequence in order to avoid bias in this field. SNOSE technique was used to hide it.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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In this study, participants and outcome evaluators are blinded to the study groups. The outcome evaluator performs the evaluation without knowing which intervention group the participant belongs to. According to the explanations stated in the informed consent, the participants are told that they are randomly assigned to the intervention groups and, if they are in the control group, after the completion of the test, they will undergo the same number of sessions considered for the other patients. In the control group, the participant will receive the sham TMS. That is, all the parameters are the same as the actual TMS group, except that coil angle is different. Therefore, the participants are blinded to the type of treatment they receive.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Secondary Ids
1
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Registry name
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clinicaltrials.gov
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Secondary trial Id
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NCT03468686
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Registration date
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2018-02-06, 1396/11/17
Ethics committees
1
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Ethics committee
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Approval date
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2018-01-22, 1396/11/02
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Ethics committee reference number
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IR.IUMS.REC.1396.0339
Health conditions studied
1
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Description of health condition studied
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major depression disorder
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ICD-10 code
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F33
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ICD-10 code description
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Major depressive disorder, recurrent
Primary outcomes
1
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Description
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Anhedonia
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Timepoint
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baseline, ten session
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Method of measurement
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Snaith-Hamilton Pleasure Scale (SHAPS)
2
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Description
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Rumination
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Timepoint
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baseline, ten session
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Method of measurement
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Ruminative Response Scale (RRS)
3
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Description
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Anhedonia network
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Timepoint
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baseline, ten session
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Method of measurement
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EEG
4
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Description
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default mode network
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Timepoint
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baseline, ten session
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Method of measurement
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EEG
Secondary outcomes
1
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Description
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Score of depression
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Timepoint
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baseline, ten session
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Method of measurement
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Hamilton Depression Rating Scale
2
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Description
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score of anxiety
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Timepoint
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baseline, ten session
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Method of measurement
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Hamilton Anxiety Rating Scale
Intervention groups
1
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Description
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Intervention group: Repetitive transcranial magnetic stimulation
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Category
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Treatment - Devices
2
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Description
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Control group: Sham repetitive transcranial magnetic stimulation
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Atieh Clinical Neuroscience Center
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Proportion provided by this source
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100
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Persons
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available
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Title and more details about the data/document
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The information on the main outcome of the study can be shared.
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When the data will become available and for how long
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Access time: one year after the release of the results
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To whom data/document is available
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The researchers working in the academic institutions
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Under which criteria data/document could be used
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The study data is available for writing meta-analysis.
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From where data/document is obtainable
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To receive the data, the principal researcher of the project must be contacted via email
Reza Kazemi
email:rezakazemi@ut.ac.ir
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What processes are involved for a request to access data/document
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After receiving the application for documentation, if the conditions are met, the documentation will be submitted to the applicant by the principal researcher within a week
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Comments
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