]>
IRCT20160523028008N15 IRCT 2021-06-08 Hamedan University of Medical Sciences Effectiveness of Repetitive Transcranial Magnetic Stimulation ( rTMS ) add-on therapy to Standard treatment in Major Depressive Disorder Patients with sexual dysfunction. 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 2021-08-23 anticipated 40 Complete https://irct.ir/trial/56017 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 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. 2-3 Major depressive episode. Intervention 1: Intervention group: 10 session of 20 minute of trans cranial direct current stimulation by 2 ma. Intervention 2: Control group:10 sessions of 20 minutes with the same device that is inactive. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is not a plan to make this available
public Amir Keshavarzi
Farshchian Hospital, Mirzadeh Eshghi Ave.
Hamadan Iran (Islamic Republic of) 6517838695 +98 81182851015 drkeshavarzi@yahoo.com Hamedan University of Medical Sciences scientific Amir Keshavarzi
Farshchian Hospital, Mirzadeh Eshghi Ave.
Hamadan Iran (Islamic Republic of) 6517838695 +98 81182851015 drkeshavarzi@yahoo.com Hamedan University of Medical Sciences Iran (Islamic Republic of) 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 18 years 60 years Both Patients at risk of suicide Patients with other psychiatric disorders such as bipolar disorder, psychosis, schizophrenia F32 Major depressive episode Treatment - Other Treatment - Other Intervention group: 10 session of 20 minute of trans cranial direct current stimulation by 2 ma Control group:10 sessions of 20 minutes with the same device that is inactive. Depression. Timepoint: Before and after 10 sessions of intervention. Method of measurement: Montgomery-Sberg Depression Scale and Hamilton Depression Inventory. Sexual function. Timepoint: Before and after 10 sessions of intervention. Method of measurement: Female Sexual Function Questionnaire and Arizona Sexual Experience Scale. Cognitive Assessment. Timepoint: Before and after 10 sessions of intervention. Method of measurement: Montreal Cognitive Function Questionnaire. Hamedan University of Medical Sciences Approved 2021-05-01 Research Ethic Committee of Hamadan University of Medical Sciences Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave Hamadan Hamadan Iran (Islamic Republic of)