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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This work was supported by the German Center for Brain Stimulation (GCBS) research consortium (FKZ 01EE1403G), funded by the Federal Ministry of Education and Research (BMBF).
Conflict of interest
F.P. has received speaker’s honorarium from Mag&More GmbH and support with equipment from neuroConn GmbH, Ilmenau, Germany, Mag&More GmbH and Brainsway Inc., Jerusalem. A. Hasan has been invited to scientific meetings by Lundbeck, Janssen-Cilag, and Pfizer, and he received paid speakership by Desitin, Otsuka and BAK. He is a member of the Roche Advisory Board. The other authors do not report conflicts of interest.
The clinical trial is funded by the Federal Ministry of Education and Research (Bundesministerium für Bildung und Forschung [BMBF]) within the German Center for Brain Stimulation (GCBS, FKZ 01EE1403G).
Enrolment for this study began in January 2016. At the time of submission, we have enrolled 18 participants.
Frank Padberg and Ulrike Kumpf contributed equally.
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Padberg, F., Kumpf, U., Mansmann, U. et al. 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). Eur Arch Psychiatry Clin Neurosci 267, 751–766 (2017). https://doi.org/10.1007/s00406-017-0769-y