Background Late-life depression (LLD) has a poorer long-term prognosis and higher relapse rate than in younger adults with up to one third of patients with LLD showing suboptimal response to antidepressant therapy. Also, LLD has been associated with significant impairment in cognition and daily functioning. Few studies have evaluated the therapeutic effects of high-definition transcranial direct current stimulation (HD-tDCS) on the depressive and cognitive symptoms of LDD. The current

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... controlled trial assesses the efficacy of HD-tDCS as an augmentation therapy with antidepressants compared to sham-control in subjects with LLD. Method Fifty-eight patients with LLD will be recruited and randomly assigned to the active HD-tDCS or sham HD-tDCS group. In both groups, patients will receive the active or sham intervention in addition to their pre-existing antidepressant therapy, for 2 weeks with 5 sessions per week, with each lasting 30 minutes. The primary outcome measures will be the change of depressive symptoms, the clinical response and the remission rate as measured with the HAMD-17 before and after the intervention, and at 4 th and 12 th week after completed intervention. Secondary outcome measures include cognitive symptoms, anxiety symptoms, daily functioning and adverse effects. Discussion Older adults with depression are associated with poorer outcomes with unsatisfactory responses to antidepressant therapy and significant cognitive decline thus a new effective treatment option is needed. This randomized control trial aims at assessing the efficacy of HD-tDCS on ameliorating the depressive, cognitive and anxiety symptoms and improving daily functioning of subjects with LLD. Trial registration : ClinicalTrials.gov ID NCT05322863 released on 11 April 2022 https://clinicaltrials.gov/ct2/show/NCT05322863