Transcranial direct current stimulation as an additional treatment to selective serotonin reuptake inhibitors in adults with major depressive disorder in Germany (DepressionDC): a triple-blind, randomised, sham-controlled, multicentre trial

Burkhardt, Gerrit

; Kumpf, Ulrike ; Crispin, Alexander ; Goerigk, Stephan ; Andre, Elisabeth ; Plewnia, Christian ; Brendel, Bettina ; Fallgatter, Andreas ; Langguth, Berthold ; Abdelnaim, Mohamed

; Hebel, Tobias ; Normann, Claus ; Frase, Lukas ; Zwanzger, Peter ; Diemer, Julia

; Kammer, Thomas

; Schönfeldt-Lecuona, Carlos ; Kamp, Daniel ; Bajbouj, Malek ; Behler, Nora ; Wilkening, Anja ; Nenov-Matt, Tabea ; Dechantsreiter, Esther ; Keeser, Daniel

; Bulubas, Lucia ; Palm, Ulrich ; Blankenstein, Christiane ; Mansmann, Ulrich ; Falkai, Peter ; Brunoni, Andre R ; Hasan, Alkomiet ; Padberg, Frank

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Background Transcranial direct current stimulation (tDCS) has been proposed as a feasible treatment for major depressive disorder (MDD). However, meta-analytic evidence is heterogenous and data from multicentre trials are scarce. We aimed to assess the efficacy of tDCS versus sham stimulation as an additional treatment to a stable dose of selective serotonin reuptake inhibitors (SSRIs) in adults with MDD. Methods The DepressionDC trial was triple-blind, randomised, and sham-controlled and conducted at eight hospitals in Germany. Patients being treated at a participating hospital aged 18-65 years were eligible if they had a diagnosis of MDD, a score of at least 15 on the Hamilton Depression Rating Scale (21-item version), no response to at least one antidepressant trial in their current depressive episode, and treatment with an SSRI at a stable dose for at least 4 weeks before inclusion; the SSRI was continued at the same dose during stimulation. Patients were allocated (1:1) by fixed-blocked randomisation to receive either 30 min of 2 mA bifrontal tDCS every weekday for 4 weeks, then two tDCS sessions per week for 2 weeks, or sham stimulation at the same intervals. Randomisation was stratified by site and baseline Montgomery-& Aring;sberg Depression Rating Scale (MADRS) score (ie, <31 or >= 31). Participants, raters, and operators were masked to treatment assignment. The primary outcome was change on the MADRS at week 6, analysed in the intention-to-treat population. Safety was assessed in all patients who received at least one treatment session. The trial was registered with ClinicalTrials.gov (NCT02530164).Findings Between Jan 19, 2016, and June 15, 2020, 3601 individuals were assessed for eligibility. 160 patients were included and randomly assigned to receive either active tDCS (n=83) or sham tDCS (n=77). Six patients withdrew consent and four patients were found to have been wrongly included, so data from 150 patients were analysed (89 [59%] were female and 61 [41%] were male). No intergroup difference was found in mean improvement on the MADRS at week 6 between the active tDCS group (n=77; -8<middle dot>2, SD 7<middle dot>2) and the sham tDCS group (n=73; -8<middle dot>0, 9<middle dot>3; difference 0<middle dot>3 [95% CI -2<middle dot>4 to 2<middle dot>9]). Significantly more participants had one or more mild adverse events in the active tDCS group (50 [60%] of 83) than in the sham tDCS group (33 [43%] of 77; p=0<middle dot>028).

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