Title
Effect of Self-administered tDCS in Patients With MDD
Effect of Self-administered Transcranial Direct Stimulation in Patients With Major Depressive Disorder: A Prospective, Randomized, Single-blinded Clinical Trial
Phase
Phase 4Lead Sponsor
Catholic University of KoreaStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Major Depressive DisorderIntervention/Treatment
Antidepressant Drug(escitalopram) ...Study Participants
58In this randomized, single-blinded clinical trial, 58 patients with major depressive disorder were assigned to active and sham tDCS stimulation groups in a 1:1 ratio, and treatment responses were evaluated biweekly over six weeks.
Patients were randomized to receive either real or sham-tDCS as well as anti-depressant drugs. tDCS was applied over the left (anode) and right (cathode) dorsolateral prefrontal cortex (DLPFC). Patients visited the hospital to get tDCS administrations 5 days a week for 2 weeks. They were evaluated every 2 weeks.
Participants visited the hospital four times (biweekly for two weeks). During their second visit, a research nurse instructed each participant on use of home-based tDCS equipment (YDS-301N; Ybrain Inc., Seongnam-si, Korea) and all participants thereafter conducted tDCS treatment at home once a day for 30 minutes (five times per week).
Participants in both active and sham groups were prescribed escitalopram in combination with tDCS treatment.
the current rose slowly for 30 seconds, descended for 30 seconds, and then remained at zero for 29 minutes
2mA of current was delivered during the 30 minutes of treatment
Inclusion Criteria: Has a diagnosis of a major depressive disorder as confirmed by the SCID-IV and MINI (without psychotic features) Greater than 22 points of Montgomery-Asberg Depression Rating Scale Aged 19 to 65. Has provided informed consent Has received Escitalopram as a combined antidepressant during the study period Exclusion Criteria: Has other mental disorders diagnosed by Axis-I, except major depressive disorder (However, subject who is diagnosed as both major depressive disorder as well as anxiety disorder can participate the study.) History of suicidal attempt in the last 6 months Diagnosed with bipolar or psychotic major depressive disorder Diagnosed with other depressive disorders: dysthymic disorder, and depressive disorders that are not elsewhere classified. Has hypersensitivity to Escitalopram ingredients A score of 5 or greater for the question #10 in MADRS Diagnosed with closed angle glaucoma or has a history of glaucoma. History of participation in other clinical trials within 30days. A major and/or unstable medical or neurologic illness Currently taking substances pimozide Pregnant or has a positive pregnancy serum test.
