A Randomized Controlled Single-blind Trial of Transcranial Direct Current Stimulation as Early Augmentation in Major Depressive Disorder: Protocol of a Proof-of-Concept Study

Abstract

Background: Transcranial direct current stimulation (tDCS) used for augmentation improves depressive symptoms in patients who have a partial or poor response to antidepressant medications. However, its role and effectiveness as an early intervention have not been studied much. This study aims to determine the efficacy and safety of add-on tDCS as an early augmentation strategy in drug-naive patients with major depressive disorder.Methods: A total of 40 patients will be enrolled in the study, randomized into two groups (active and sham), and receive uniform medication Escitalopram 10 mg per day. A total of 10 sessions of tDCS will be given within 2 weeks. Assessments will be done using scales Hamilton Anxiety Rating Scale (HAM-A), Hamilton Depression Rating Scale (HAM-D) and Beck’s Depression Inventory (BDI) at baseline, week 2, and week 4 of the study. After each session of tDCS, a side effects checklist will be applied to monitor side effects. The trial has been registered in the Clinical Trials Registry, India(CTRI/2022/01/039123).Result: After data collection, statistical analysis will be done using a computerized statistical program, Statistical Package for Social Sciences. Mean changes in the rating scale scores will be compared after each assessment and between the groups. Conclusion: The findings will help to assess the efficacy of tDCS in the early augmentation of depressive disorder