Background Post-stroke depression is a disabling condition occurring in about one-third of patients with stroke. Pharmacological treatments have limited efficacy and important side effects. Recently, transcranial direct current stimulation (tDCS) has shown efficacy in treating depression. This study aimed to assess the efficacy and safety of tDCS for post-stroke depression.

Methods 48 antidepressant-free patients with post-stroke depression were randomised into two groups (active and sham tDCS). 12 30 min sessions of 2 mA anodal left/cathodal right dorsolateral prefrontal tDCS were administered over 6 weeks (once daily on weekdays for 2 weeks, then 1 session every other week). The primary outcome was the change in the Hamilton Depression Rating Scale (17-items) at 6 weeks. We employed a repeated-measures analysis of variance; the depression score was the dependent variable, and time and group were independent variables. In this intention-to-treat analysis, missing data were addressed according to the last observation carried forward and the mixed-model repeated-measures analysis methods.

Results 5 patients dropped out (two in the active group). Active tDCS was significantly superior to sham at end point (mean difference, 4.7 points; SD=9.21; p<0.001). Response and remission rates were significantly higher in the active (37.5% and 20.8%, respectively) versus the sham (4.1% and 0%, respectively) group, with a number-needed-to-treat of 3 and 5, respectively.

Conclusions This was the first controlled study to demonstrate that tDCS was safe and effective for post-stroke depression. Therefore, tDCS might be a favourable option for treating these patients.

Trial registration number NCT01525524; Results.