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