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European Archives of Psychiatry and Clinical Neuroscience

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01-12-2017 | Original Paper

Prefrontal transcranial direct current stimulation (tDCS) as treatment for major depression: study design and methodology of a multicenter triple blind randomized placebo controlled trial (DepressionDC)

Authors: Frank Padberg, Ulrike Kumpf, Ulrich Mansmann, Ulrich Palm, Christian Plewnia, Berthold Langguth, Peter Zwanzger, Andreas Fallgatter, Jana Nolden, Max Burger, Daniel Keeser, Rainer Rupprecht, Peter Falkai, Alkomiet Hasan, Silvia Egert, Malek Bajbouj

Published in: European Archives of Psychiatry and Clinical Neuroscience | Issue 8/2017

Abstract

Transcranial direct current stimulation (tDCS) has been proposed as novel treatment for major depressive disorder (MDD) based on clinical pilot studies as well as randomized controlled monocentric trials. The DepressionDC trial is a triple-blind (blinding of rater, operator and patient), randomized, placebo controlled multicenter trial investigating the efficacy and safety of prefrontal tDCS used as additive treatment in MDD patients who have not responded to selective serotonin reuptake inhibitors (SSRI). At 5 study sites, 152 patients with MDD receive a 6-weeks treatment with active tDCS (anode F3 and cathode F4, 2 mA intensity, 30 min/day) or sham tDCS add-on to a stable antidepressant medication with an SSRI. Follow-up visits are at 3 and 6 months after the last tDCS session. The primary outcome measure is the change of the Montgomery-Asberg Depression Rating Scale (MADRS) scores at week 6 post-randomisation compared to baseline. Secondary endpoints also cover other psychopathological domains, and a comprehensive safety assessment includes measures of cognition. Patients undergo optional investigations comprising genetic testing and functional magnetic resonance imaging (fMRI) of structural and functional connectivity. The study uses also an advanced tDCS technology including standard electrode positioning and recording of technical parameters (current, impedance, voltage) in every tDCS session. Aside reporting the study protocol here, we present a novel approach for monitoring technical parameters of tDCS which will allow quality control of stimulation and further analysis of the interaction between technical parameters and clinical outcome. The DepressionDC trial will hopefully answer the important clinical question whether prefrontal tDCS is a safe and effective antidepressant intervention in patients who have not sufficiently responded to SSRIs.

Trial registry: ClinicalTrials.gov Identifier NCT0253016.

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Title: Prefrontal transcranial direct current stimulation (tDCS) as treatment for major depression: study design and methodology of a multicenter triple blind randomized placebo controlled trial (DepressionDC)
Authors: Frank Padberg
Ulrike Kumpf
Ulrich Mansmann
Ulrich Palm
Christian Plewnia
Berthold Langguth
Peter Zwanzger
Andreas Fallgatter
Jana Nolden
Max Burger
Daniel Keeser
Rainer Rupprecht
Peter Falkai
Alkomiet Hasan
Silvia Egert
Malek Bajbouj
Publication date: 01-12-2017
Publisher: Springer Berlin Heidelberg
Published in: European Archives of Psychiatry and Clinical Neuroscience / Issue 8/2017
Print ISSN: 0940-1334
Electronic ISSN: 1433-8491
DOI: https://doi.org/10.1007/s00406-017-0769-y

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Prefrontal transcranial direct current stimulation (tDCS) as treatment for major depression: study design and methodology of a multicenter triple blind randomized placebo controlled trial (DepressionDC)

Abstract

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

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