Title: Trial of Electrical Direct-Current Therapy versus Escitalopram for Depression

Brunoni, AR et al.


What You Need to Know:

In patients with unipolar depression, treatment with transcranial direct-current stimulation (tDCS) over a 10-week period was not only associated with more adverse events, but also “did not show noninferiority to escitalopram.”

Trial Design:

  • Double-blind, noninferiority study compared tDCS with selective serotonin-reuptake inhibitor therapy in patients with unipolar depression
  • 245 patients were randomized to receive tDCS + placebo (n=94), sham tDCS + escitalopram (n=91), or sham tDCS + placebo (n=60)
  • tDCS: one 30-minute session of 2-mA prefrontal stimulation was administered for 15 consecutive weekdays, then weekly for 7 weeks
  • Escitalopram dosing: 10 mg/day for 3 weeks then 20 mg/day
  • Primary endpoint: change in the Hamilton Depression Rating Scale (HDRS-17) score (higher scores indicate more depression)
  • “Noninferiority of tDCS versus escitalopram was defined by a lower boundary of the confidence interval for the difference in the decreased score that was at least 50% of the difference in the scores with placebo versus escitalopram”

Key Outcomes:

  • Average decrease (±SD) in the HDRS-17 score from baseline: 11.3±6.5 points for escitalopram patients, 9.0±7.1 points for tDCS patients, 5.8±7.9 points for placebo patients
  • Noninferiority could not be claimed: “lower boundary of the confidence interval for the difference in the decrease for tDCS versus escitalopram (difference, −2.3 points; 95% confidence interval [CI], −4.3 to −0.4; P=0.69) was lower than the noninferiority margin of −2.75 (50% of placebo minus escitalopram)”
  • Both escitalopram and tDCS were superior to placebo: 5.5 point difference vs placebo for escitalopram patients (95% CI: 3.1, 7.8; P<0.001), 3.2 point difference vs placebo for tDCS patients (95% CI: 0.7, 5.5; P=0.01)
  • tDCS group: increased rates of skin redness, tinnitus, and nervousness; 2 patients developed new-onset mania
  • Escitalopram group: increased rates of sleepiness, obstipation