Dorsomedial prefrontal cortex repetitive transcranial magnetic stimulation (dmPFC-rTMS) in the augmentation of antidepressants (DOPRERA study). Efficacy, tolerability and neurophysiological changes (NU22-04-00192)

Basic informations

Investigator: doc. MUDr. Martin Bareš, Ph.D.
Main recipient: National Institute of Mental Health (NIMH)
Research period:  1/5/2022 - 31/12/2025
Total budget: 9,641,000 CZK
Supported by: Czech Health Research Council (AZV ČR)

Annotation

Repetitive transcranial magnetic stimulation (rTMS) is an effective treatment for depression but the optimal method of administration has yet to be determined and various modifications of rTMS are available. The aim of the project is to compare the efficacy/tolerability of 4-week dorsomedialprefrontal rTMS double-cone coil (dmPFC-rTMS; deep rTMS) as the new type of rTMS to conventional rTMS and sham stimulation in the augmentation of 6-week standard antidepressant treatment (AD) from the outset of the new antidepressant treatment (double-blind, randomized, active comparator and placebo-controlled study). We planned to enrolled 60 patients (20 in each group; inpatients or outpatients). We will apply AD from SSRI group in the flexible dose according to clinical judgment of the attending psychiatrists, taking into account the history of previous treatments and clinical status. The study will also explore the changes in brain activity (EEG) during the treatment and their association with treatment outcome in the regions implicated in the pathophysiology of depression. The project will meet the following objectives of the Applied Health Research Support Program for 2020- 2026 (Subprogram 1): to support the development of new diagnostic and therapeutic methods and to ensure that the results of applied medical research are used as inputs for the development and updating of clinical guidelines in the Czech Republic. It also contributes to the priorities of the subprogram 1.4 Nervous system and mental diseases (1.4.2: Diagnosis of nervous system diseases, 1.4.3 Increased effectiveness of treatments for nervous system diseases). The project builds on our previous works comparing the effectiveness of AD and neurostimulation methods (rTMS; tDCS).The ultimate goal of the project is to contribute to the optimization of antidepressant treatment, to expand knowledge on neurostimulation treatments and to contribute to the introduction of the method into clinical practice.