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

Publication ,  Journal Article
Alonzo, A; Aaronson, S; Bikson, M; Husain, M; Lisanby, S; Martin, D; McClintock, SM; McDonald, WM; O'Reardon, J; Esmailpoor, Z; Loo, C
Published in: Contemp Clin Trials
November 2016

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.

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Published In

Contemp Clin Trials

DOI

EISSN

1559-2030

Publication Date

November 2016

Volume

51

Start / End Page

65 / 71

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Transcranial Direct Current Stimulation
  • Public Health
  • Humans
  • General Clinical Medicine
  • Double-Blind Method
  • Depressive Disorder, Major
  • Depression
  • Bipolar Disorder
  • 42 Health sciences
 

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Alonzo, A., Aaronson, S., Bikson, M., Husain, M., Lisanby, S., Martin, D., … Loo, C. (2016). Study design and methodology for a multicentre, randomised controlled trial of transcranial direct current stimulation as a treatment for unipolar and bipolar depression. Contemp Clin Trials, 51, 65–71. https://doi.org/10.1016/j.cct.2016.10.002
Alonzo, Angelo, Scott Aaronson, Marom Bikson, Mustafa Husain, Sarah Lisanby, Donel Martin, Shawn M. McClintock, et al. “Study design and methodology for a multicentre, randomised controlled trial of transcranial direct current stimulation as a treatment for unipolar and bipolar depression.Contemp Clin Trials 51 (November 2016): 65–71. https://doi.org/10.1016/j.cct.2016.10.002.
Alonzo, Angelo, et al. “Study design and methodology for a multicentre, randomised controlled trial of transcranial direct current stimulation as a treatment for unipolar and bipolar depression.Contemp Clin Trials, vol. 51, Nov. 2016, pp. 65–71. Pubmed, doi:10.1016/j.cct.2016.10.002.
Alonzo A, Aaronson S, Bikson M, Husain M, Lisanby S, Martin D, McClintock SM, McDonald WM, O’Reardon J, Esmailpoor Z, Loo C. Study design and methodology for a multicentre, randomised controlled trial of transcranial direct current stimulation as a treatment for unipolar and bipolar depression. Contemp Clin Trials. 2016 Nov;51:65–71.
Journal cover image

Published In

Contemp Clin Trials

DOI

EISSN

1559-2030

Publication Date

November 2016

Volume

51

Start / End Page

65 / 71

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Transcranial Direct Current Stimulation
  • Public Health
  • Humans
  • General Clinical Medicine
  • Double-Blind Method
  • Depressive Disorder, Major
  • Depression
  • Bipolar Disorder
  • 42 Health sciences