Transcranial Direct Current Stimulation in Major Depressive Disorder
A double-blind, placebo-controlled, randomized, superiority trial.
Background
We compared transcranial direct-current stimulation (tDCS) with sham stimulation for the treatment of depression.
Methods
In a multicenter, double-blind, superiority trial, conducted at the University of East London and the University of Texas Health Science Center at Houston, involving adults (18+) with nontreatment-resistant unipolar depression, we randomly assigned patients to receive tDCS or, sham tDCS.
The tDCS was administered in 30-minute, 2-mA prefrontal stimulation sessions for 15 consecutive weekdays, followed by 3 sessions for 7 weeks. Sessions were done by the patients themselves at home using the Flow FL-100 tDCS headset.
The primary outcome measure was the change in the 17-item Hamilton Depression Rating Scale (HDRS-17) score (range, 0 to 52, with higher scores indicating more depression). As secondary outcomes, the response and remission rates based on the HDRS-17 and the Montgomery-Åsberg Depression Rating Scale (MADRS) were used.
Results
A total of 173 patients underwent randomization, with 86 being assigned to active tDCS and 87 to sham tDCS.
In the intention-to-treat analysis, the mean (±SD) change in the score from baseline was -10.2±5.4 points in the active tDCS group, and -7.8±5 points in the sham group. Active tDCS was superior to sham (adjusted difference vs. sham, -2.2 points [95% CI, -3.9 to -0.5; P=0.013]).
The HDRS-17 response rate (defined as at least a 50% reduction from baseline) was 53.6% and 28.6% for the active and sham group [OR=2.88; 95% CI, 1.42 to 5.84; P=0.003], respectively.
The HDRS-17 remission rate (score ≤ 7) was 45.2% vs 22.7% for the active vs. sham group [OR=2.80; 95% CI, 1.37 to 5.72; P=0.005].
The MADRS response and remission rates (score ≤ 10) were 62.6% vs. 32.7% [OR=3.45; 95% CI, 1.66 to 7.18; P<0.001] and 57.1% vs. 30.2% [OR=3.08; 95% CI, 1.44 to 6.57; P<0.003] for the active vs sham group, respectively.
The active tDCS group had significantly higher instances of dry skin and skin irritation. No serious adverse events related to the device usage were reported.
Conclusions
In a double-blind multicenter trial, tDCS for the treatment of depression did show superiority to sham tDCS over a 10-week period.
No serious adverse events were reported and the treatment was well tolerated.