Original scientific paper

https://doi.org/10.24869/psyd.2018.41

EFFICACY AND SAFETY OF REPETITIVE TRANSCRANIAL MAGNETIC STIMULATION USING AN H1-COIL OR FIGURE-8-COIL IN THE TREATMENT OF UNIPOLAR MAJOR DEPRESSIVE DISORDER: A STUDY PROTOCOL FOR A RANDOMIZED CONTROLLED TRIAL

Igor Filipčić ; Psychiatric Hospital “Sveti Ivan”, Zagreb, Croatia; Faculty of Dental Medicine and Health, Josip Juraj Strossmayer University of Osijek, Osijek, Croatia; School of Medicine, University of Zagreb, Zagreb, Croatia
Ivona Šimunović Filipčić ; Department of psychological medicine, University Hospital Center Zagreb, Zagreb, Croatia
Tomislav Gajšak ; Psychiatric Hospital “Sveti Ivan”, Zagreb, Croatia
Željko Milovac ; Psychiatric Hospital “Sveti Ivan”, Zagreb, Croatia
Strahimir Sučić ; Psychiatric Hospital “Sveti Ivan”, Zagreb, Croatia
Ena Ivezić ; Psychiatric Hospital “Sveti Ivan”, Zagreb, Croatia
Sandra Zečević Penić ; Psychiatric Hospital “Sveti Ivan”, Zagreb, Croatia
Ivana Orgulan ; Psychiatric Hospital “Sveti Ivan”, Zagreb, Croatia
Damir Šebo ; Faculty of Dental Medicine and Health, Josip Juraj Strossmayer University of Osijek, Osijek, Croatia
Vjekoslav Jeleč ; Department of Neurosurgery, Clinical Hospital “Dubrava,” Zagreb, Croatia
Žarko Bajić ; Psychiatric Hospital “Sveti Ivan”, Zagreb, Croatia

Abstract

Repetitive transcranial magnetic stimulation (rTMS) is a noninvasive technique with few side effects that has been reported to be effective in the treatment of major depressive disorder (MDD). At present, no randomized controlled trials (RCT) have compared the efficacy and safety of rTMS delivered by the figure-8-coil and the H1-coil. We describe an industry-independent, randomized, controlled, single-blinded, single-center study protocol assessing the differences in efficacy and safety of rTMS for patients diagnosed with MDD with the H1-coil and figure-8-coil as an add-on to stable pharmacotherapy or pharmacotherapy alone. Stimulation protocols follow those that led to the FDA clearance of these treatments for MDD. The sample of 76 patents in each of the three groups will be enrolled and assessed with clinical and neuropsychological tests. The primary outcome is remission rate defined as Hamilton depression rating scale (HAM-D17) score ≤7 at the end of week-4. This clinical trial will address the efficacy and safety of rTMS modalities for MDD. The evaluation of biological markers will
also help to elucidate the pathophysiology of MDD and the mechanisms of action of rTMS.

Keywords

repetitive transcranial magnetic stimulation; rTMS; deep TMS; dTMS; major depressive disorder

Hrčak ID:

195969

URI

https://hrcak.srce.hr/195969

Publication date:

16.3.2018.

Visits: 2.108 *