Safety and efficacy of early augmentation with Transcranial Direct Current Stimulation (tDCS) in adolescents with Major Depressive Disorder: A randomized controlled trial.

Abstract

Background: Transcranial Direct Current Stimulation (tDCS) is an emerging modality with demonstrated efficacy in Major Depressive Disorder (MDD), however, there is paucity of research in adolescent depression. This study attempts to evaluate the safety and efficacy of tDCS in adolescents with MDD as an early augmentation to drug therapy.

Methods: Adolescents with MDD aged 10-18 years were enrolled in the study and allocated to active or sham groups as per randomization. Sertraline was given in the range of 25-50 mg to each participant. After baseline assessments, 10 sessions of tDCS were given with 2 mA current for 20 minutes, keeping anode at left DLPFC and cathode at right DLPFC. Side effects were assessed and rating scales were reapplied at 2 weeks and then 6 weeks. Results were analyzed.

Results: A total of 32 patients were analysed (15-active, 17-sham). At 2 weeks, the BDI and BAI scores of the true group were significantly lower than the sham group, and the reduction in the scores of the former was statistically greater. This significance did not persist at 6 weeks, and the reduction in the scores of the two groups was significantly different from baseline to 2-weeks and 6-weeks. Response and remission rates were higher in the active group at 6 weeks. Adverse effects were comparable.

Conclusion: tDCS is safe and effective for early augmentation of drugs in adolescents with MDD. However, effects do not last long after termination of sessions. Further studies are needed with a larger sample size and longer follow-ups.