Effect of Home-based Self-administered Transcranial Direct Stimulation in Patients with Mild to Moderate Major Depressive Disorder: A Single-arm, Multicentral Trial.

Abstract

Although the effects and safety of transcranial direct current stimulation (tDCS) treatment in depressive patients are largely investigated, whether the self-administration of tDCS treatment at patient's home is comparable to clinic-based treatment is still unknown. In this single-arm, multi-center clinical trial, 61 patients with mild to moderate major depressive disorder were enrolled. tDCS treatment was delivered at the patient's home once a day, 5 to 7 times a week for 6 weeks, and each session lasted for 30 minutes. The primary outcome was a total Beck-Depression Inventory-II score, and no concurrent antidepressants were used. The remission rates in both Full-Analysis (FA) (n = 61) and Per-Protocol (PP) (n = 43) groups were statistically significant (FA: 57.4% [0.44-0.70], PP: 62.8% [0.47-0.77]; percent [95% confidence interval]). The degree of depression- related symptoms was also significantly improved in 2, 4, and 6 weeks after the treatment when compared with baseline. There was no significant association between treatment compliance and remission rate in both FA and PP groups. These results suggest that acute treatment of patient-administered tDCS might be effective in improving the subjective feeling of depressive symptoms in mild to moderate major depressive disorder patients.