Study design and methodology for a multicentre, randomised controlled trial of transcranial direct current stimulation as a treatment for unipolar and bipolar depression.

Journal Article

Transcranial Direct Current Stimulation (tDCS) is a new, non-invasive neuromodulation approach for treating depression that has shown promising efficacy. The aim of this trial was to conduct the first international, multicentre randomised controlled trial of tDCS as a treatment for unipolar and bipolar depression. The study recruited 120 participants across 6 sites in the USA and Australia. Participants received active or sham tDCS (2.5mA, 20 sessions of 30min duration over 4weeks), followed by a 4-week open label active treatment phase and a 4-week taper phase. Mood and neuropsychological outcomes were assessed with the primary antidepressant outcome measure being the Montgomery-Asberg Depression Rating Scale (MADRS). A neuropsychological battery was administered to assess safety and examine cognitive effects. The study also investigated the possible influence of genetic polymorphisms on outcomes. The trial was triple-blinded. Participants, tDCS treaters and study raters were blinded to each participant's tDCS group allocation in the sham-controlled phase. Specific aspects of tDCS administration, device operation and group allocation were designed to optimise the integrity of blinding. Outcome measures will be tested using a mixed effects repeated measures analysis with the primary factors being Time as a repeated measure, tDCS condition (sham or active) and Diagnosis (unipolar or bipolar). A restricted number of random and fixed factors will be included as required to account for extraneous differences. As a promising treatment, tDCS has excellent potential for translation into widespread clinical use, being cost effective, portable, easy to operate and well tolerated.

Full Text

Duke Authors

Cited Authors

  • Alonzo, A; Aaronson, S; Bikson, M; Husain, M; Lisanby, S; Martin, D; McClintock, SM; McDonald, WM; O'Reardon, J; Esmailpoor, Z; Loo, C

Published Date

  • November 2016

Published In

Volume / Issue

  • 51 /

Start / End Page

  • 65 - 71

PubMed ID

  • 27756567

Electronic International Standard Serial Number (EISSN)

  • 1559-2030

International Standard Serial Number (ISSN)

  • 1551-7144

Digital Object Identifier (DOI)

  • 10.1016/j.cct.2016.10.002

Language

  • eng