PSYLECT (tDCS only vs. double sham)
Trial question
What is the role of home-use transcranial direct current stimulation in patients with major depressive episode?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
86.0% female
14.0% male
N = 146
146 patients (126 female, 20 male).
Inclusion criteria: adult patients, aged 18-59 years, with a diagnosis of major depression and on an acute depressive episode of at least moderate severity.
Key exclusion criteria: neurologic or clinical disorders; other psychiatric disorders except for anxiety; and contraindications to transcranial direct current stimulation.
Interventions
N=73 tDCS only (home-use transcranial direct current stimulation administered in 2-mA, 30 minute prefrontal sessions for 15 consecutive weekdays and twice-weekly sessions for 3 weeks).
N=73 double sham (sham home-use transcranial direct current stimulation of 1-mA, 90 second duration plus internet browsing).
Primary outcome
Reduction in Hamilton Depression Rating Scale 17-item version score at week 6
8.5 points
7.7 points
8.5 points
6.4 points
4.3 points
2.1 points
0.0 points
TDCS
only
Double
sham
No significant
difference ↔
No significant difference in reduction in Hamilton Depression Rating Scale 17-item version score at week 6 (8.5 points vs. 7.7 points; AD 0.8 points, 95% CI -0.86 to 2.46).
Secondary outcomes
No significant difference in clinical response at week 6 (36% vs. 38%; OR 0.89, 95% CI -3.92 to 5.7).
No significant difference in remission at week 6 (18% vs. 21%; OR 0.84, 95% CI -2.87 to 4.55).
Safety outcomes
No significant difference in adverse events.
Conclusion
In adult patients, aged 18-59 years, with a diagnosis of major depression and on an acute depressive episode of at least moderate severity, tDCS only was not superior to double sham with respect to reduction in Hamilton Depression Rating Scale 17-item version score at week 6.
Reference
Lucas Borrione, Beatriz A Cavendish, Luana V M Aparicio et al. Home-Use Transcranial Direct Current Stimulation for the Treatment of a Major Depressive Episode: A Randomized Clinical Trial. JAMA Psychiatry. 2024 Apr 1;81(4):329-337.
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