Efficacy and Safety of Accelerated Transcranial Magnetic Stimulation With H1-coil (dTMS)
Efficacy and Safety of Accelerated Transcranial Magnetic Stimulation With H1-coil (dTMS)
The purpose of this study is to examine the efficacy and safety of accelerated transcranial
 magnetic stimulation with H1-coil (deep TMS) for treatment of patients diagnosed with major
 depressive disorder (MDD). Subjects will be randomized into two groups: experimental (treated
 with accelerated deep TMS: twice a day (6-8 hours between two applications), during 2 weeks)
 and control group (standard deep TMS treatment: once a day, during 4 weeks). Participants and
 designated clinicians will complete a battery of instruments that measure relevant symptoms
 (HAM-D17 and BDI-II scales), global functioning (CGI and PHQ-9 scales), quality of life
 (EQ-5D-5L questionnaire), and cognitive functions (MoCA test). Measurements will be done in 4
 time points: after the inclusion, after the first week of treatment, after the second week
 (the end of treatment for experimental group), after the fourth week (the end of treatment
 for control group), and after 1 month (follow-up for both groups). Interim data analysis is
 planned at the time when at least 30 participants are involved in both groups. Patients whose
 baseline score on HAM-D17 is equal or greater than 24 (very severe depression) will be
 included in another study; they will be treated with accelerated deep TMS twice a day during
 4 weeks.
Inclusion Criteria:

 -  diagnosed major depressive disorder (ICD10: F32.1, F32.2, F33.1, F33.2)

 -  current depressive episode lasts for at least 4 weeks

 -  HAM-D17 score ≥15

 -  CGI-Score ≥4

 -  inadequate response to antidepressant therapy

 Exclusion Criteria:

 -  diagnosed psychotic disorder

 -  diagnosed depressive disorder with psychotic features

 -  diagnosed bipolar affective disorder

 -  diagnosed posttraumatic stress disorder

 -  diagnosed obsessive-compulsive disorder

 -  anxiety disorder or personality disorder as primary diagnoses

 -  alcohol or drug addiction

 -  neurological disorders and brain implants

 -  pregnancy

 -  former TMS treatment within 6 months

 -  unable to complete the questionnaires