title: Study design and methodology for a multicentre, randomised controlled trial of transcranial direct current stimulation as a treatment for unipolar and bipolar depression.
abstract: 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.
authors.affiliation: School of Psychiatry, University of New South Wales/Black Dog Institute, Sydney, NSW, Australia. Electronic address: a.alonzo@unsw.edu.au.
authors.forename: Angelo
authors.initials: A
authors.lastname: Alonzo
authors.affiliation: Sheppard Pratt Health System, Clinical Research Programs, Baltimore, MD, USA.
authors.forename: Scott
authors.initials: S
authors.lastname: Aaronson
authors.affiliation: Department of Biomedical Engineering, City College of New York, New York, NY, USA.
authors.forename: Marom
authors.initials: M
authors.lastname: Bikson
authors.affiliation: Department of Psychiatry, UT Southwestern Medical Center, Dallas, TX, USA; Department of Psychiatry and Behavioural Sciences, Duke University School of Medicine, Durham, NC, USA.
authors.forename: Mustafa
authors.initials: M
authors.lastname: Husain
authors.affiliation: Department of Psychiatry and Behavioural Sciences, Duke University School of Medicine, Durham, NC, USA; Division of Translational Research, and Noninvasive Neuromodulation Unit, Experimental Therapeutics and Pathophysiology Branch, NIMH, NIH, Bethesda, MD, USA.
authors.forename: Sarah
authors.initials: S
authors.lastname: Lisanby
authors.affiliation: School of Psychiatry, University of New South Wales/Black Dog Institute, Sydney, NSW, Australia.
authors.forename: Donel
authors.initials: D
authors.lastname: Martin
authors.affiliation: Department of Psychiatry, UT Southwestern Medical Center, Dallas, TX, USA; Department of Psychiatry and Behavioural Sciences, Duke University School of Medicine, Durham, NC, USA.
authors.forename: Shawn M
authors.initials: SM
authors.lastname: McClintock
authors.affiliation: Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, GA, USA.
authors.forename: William M
authors.initials: WM
authors.lastname: McDonald
authors.affiliation: Rowan University School of Osteopathic Medicine, Cherry Hill, NJ, USA.
authors.forename: John
authors.initials: J
authors.lastname: O'Reardon
authors.affiliation: Department of Biomedical Engineering, City College of New York, New York, NY, USA.
authors.forename: Zeinab
authors.initials: Z
authors.lastname: Esmailpoor
authors.affiliation: School of Psychiatry, University of New South Wales/Black Dog Institute, Sydney, NSW, Australia.
authors.forename: Colleen
authors.initials: C
authors.lastname: Loo
mesh_terms: D001714:Bipolar Disorder / Q000523:psychology / Q000628:therapy*; D003863:Depression / Q000523:psychology / Q000628:therapy*; D003865:Major Depressive Disorder / Q000523:psychology / Q000628:therapy*; D004311:Double-Blind Method; D006801:Humans; D065908:Transcranial Direct Current Stimulation / Q000379:methods*; D016896:Treatment Outcome
keywords: Bipolar; Depression; Neurostimulation; Transcranial direct current stimulation