Journal of affective disorders · 2025
The Portable Transcranial Electrical Stimulation and Internet-Based Behavioral Therapy for Major Depression Study (PSYLECT): Results of the maintenance phase.
Клиническое исследование I фазыКлиническое исследование II фазыКлиническое исследование III фазыСтатьяРандомизированное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Aparicio Luana V M, Luethi Matthias S, Borrione Lucas, Moran Natasha K S, Cavendish Beatriz A, Silva Valquiria A, Valiengo Leandro, Goerigk Stephan, Padberg Frank, Razza Lais B, Vidal Kallene S M, Brunoni Andre R
Аннотация
BACKGROUND: Transcranial direct current stimulation (tDCS) has demonstrated antidepressant efficacy, but optimal strategies for long-term maintenance remain unexplored. While clinic-based maintenance tDCS poses adherence and logistical challenges, home-based protocols may improve accessibility and prevent attrition.
OBJECTIVE: To evaluate the efficacy and safety of home-based tDCS for relapse prevention in patients with major depressive disorder (MDD) during the maintenance phase of the PSYLECT trial.
METHODS: Following the randomized controlled trial (Phase I, n = 210) and open-label crossover (Phase II), responders (≥50 % improvement in Hamilton Depression Rating Scale scores) were enrolled in Phase III: a 6-month, open-label continuation protocol involving twice-weekly home-based tDCS sessions (2 mA, 30 min, F3-F4 montage) with or without digital behavioral therapy (BT). The primary outcome was time to relapse, analyzed using Kaplan-Meier survival curves. Cox regression assessed predictors of relapse.
RESULTS: Seventy-one patients (mean age 37.9 ± 9.0 years; 89 % female) were included in Phase III. At 24 weeks, 75 % (95 % CI, 64.2-82.8) remained without relapse or discontinuation, while survival without relapse alone was 82 %. Six participants (8.5 %) relapsed, and 11 (15.5 %) discontinued. No significant predictors of relapse were identified, nor did BT significantly enhance survivability. Adverse events were predominantly mild; most common were transient scalp itching (21 %) and headaches (18 %), while 40 % of participants reported no adverse events by month 6.
CONCLUSION: Home-based maintenance tDCS was safe, feasible, and led to clinically meaningful relapse prevention comparable to clinic-based protocols. Its advantages in terms of scalability, cost-effectiveness and accessibility support its potential as a maintenance strategy for MDD.
OBJECTIVE: To evaluate the efficacy and safety of home-based tDCS for relapse prevention in patients with major depressive disorder (MDD) during the maintenance phase of the PSYLECT trial.
METHODS: Following the randomized controlled trial (Phase I, n = 210) and open-label crossover (Phase II), responders (≥50 % improvement in Hamilton Depression Rating Scale scores) were enrolled in Phase III: a 6-month, open-label continuation protocol involving twice-weekly home-based tDCS sessions (2 mA, 30 min, F3-F4 montage) with or without digital behavioral therapy (BT). The primary outcome was time to relapse, analyzed using Kaplan-Meier survival curves. Cox regression assessed predictors of relapse.
RESULTS: Seventy-one patients (mean age 37.9 ± 9.0 years; 89 % female) were included in Phase III. At 24 weeks, 75 % (95 % CI, 64.2-82.8) remained without relapse or discontinuation, while survival without relapse alone was 82 %. Six participants (8.5 %) relapsed, and 11 (15.5 %) discontinued. No significant predictors of relapse were identified, nor did BT significantly enhance survivability. Adverse events were predominantly mild; most common were transient scalp itching (21 %) and headaches (18 %), while 40 % of participants reported no adverse events by month 6.
CONCLUSION: Home-based maintenance tDCS was safe, feasible, and led to clinically meaningful relapse prevention comparable to clinic-based protocols. Its advantages in terms of scalability, cost-effectiveness and accessibility support its potential as a maintenance strategy for MDD.