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IRCT20100615004191N3 IRCT 2018-02-06 Atieh Clinical Neuroscience Center The study of effectiveness repetitive transcranial magnetic stimulation (rTMS) on anhedonia and rumination in patients with major depression The study of effectiveness of repetitive transcranial magnetic stimulation (rTMS) on anhedonia, rumination with their related neural circuits in patients with major depression 2016-12-21 anticipated 60 Complete https://irct.ir/trial/29173 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. N/A major depression disorder. Intervention 1: Intervention group: Repetitive transcranial magnetic stimulation. Intervention 2: Control group: Sham repetitive transcranial magnetic stimulation. Yes - There is a plan to make this available What will be shared: The information on the main outcome of the study can be shared. When: Access time: one year after the release of the results To whom: The researchers working in the academic institutions Conditions: The study data is available for writing meta-analysis. Where to obtain: To receive the data, the principal researcher of the project must be contacted via email Reza Kazemi email:rezakazemi@ut.ac.ir How to obtain: 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 Comments:
public Reza Kazemi
No 23, Vali-nezhad St, Above of vanak Sq
Tehran Iran (Islamic Republic of) 1969713663 +98 21 8401 2138 rezakazemi@ut.ac.ir Atieh Clinical Neuroscience Center scientific Reza Kazemi
No 23, Vali-nezhad St, Above of vanak Sq
Tehran Iran (Islamic Republic of) 1969713663 +98 21 8401 2138 rezakazemi@ut.ac.ir Atieh Clinical Neuroscience Center Iran (Islamic Republic of) 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 18 years 70 years Both 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 F33 Major depressive disorder, recurrent Treatment - Devices Placebo Intervention group: Repetitive transcranial magnetic stimulation Control group: Sham repetitive transcranial magnetic stimulation Anhedonia. Timepoint: baseline, ten session. Method of measurement: Snaith-Hamilton Pleasure Scale (SHAPS). Rumination. Timepoint: baseline, ten session. Method of measurement: Ruminative Response Scale (RRS). Anhedonia network. Timepoint: baseline, ten session. Method of measurement: EEG. Default mode network. Timepoint: baseline, ten session. Method of measurement: EEG. Score of depression. Timepoint: baseline, ten session. Method of measurement: Hamilton Depression Rating Scale. Score of anxiety. Timepoint: baseline, ten session. Method of measurement: Hamilton Anxiety Rating Scale. NCT03468686 clinicaltrials.gov Atieh Clinical Neuroscience Center Approved 2018-01-22 Ethics committee of Iran University of Medical Sciences Iran University of Medical Sciences, Shahid Hemmat Highway Tehran Tehran Iran (Islamic Republic of)