International randomized-controlled trial of transcranial Direct Current Stimulation in depression

Colleen K. Loo, Mustafa M. Husain, William M. McDonald, Scott Aaronson, John P. O'Reardon, Angelo Alonzo, Cynthia Shannon Weickert, Donel M. Martin, Shawn M. McClintock, Adith Mohan, Sarah H. Lisanby

Research output: Contribution to journalArticle

41 Citations (Scopus)

Abstract

Background: Evidence suggests that transcranial Direct Current Stimulation (tDCS) has antidepressant effects in unipolar depression, but there is limited information for patients with bipolar depression. Additionally, prior research suggests that brain derived neurotrophic factor (BDNF) Val66Met genotype may moderate response to tDCS. Objective: To examine tDCS efficacy in unipolar and bipolar depression and assess if BDNF genotype is associated with antidepressant response to tDCS. Methods: 130 participants diagnosed with a major depressive episode were randomized to receive active (2.5 milliamps (mA), 30 min) or sham (0.034 mA and two 60-second current ramps up to 1 and 0.5 mA) tDCS to the left prefrontal cortex, administered in 20 sessions over 4 weeks, in a double-blinded, international multisite study. Mixed effects repeated measures analyses assessed change in mood and neuropsychological scores in participants with at least one post-baseline rating in the unipolar (N = 84) and bipolar (N = 36) samples. Results: Mood improved significantly over the 4-week treatment period in both unipolar (p = 0.001) and bipolar groups (p < 0.001). Among participants with unipolar depression, there were more remitters in the sham treatment group (p = 0.03). There was no difference between active and sham stimulation in the bipolar sample. BDNF genotype was unrelated to antidepressant outcome. Conclusions: Overall, this study found no antidepressant difference between active and sham stimulation for unipolar or bipolar depression. However, the possibility that the low current delivered in the sham tDCS condition was biologically active cannot be discounted. Moreover, BDNF genotype did not moderate antidepressant outcome. Clinical Trials Registration: www.clinicaltrials.gov, NCT01562184.

Original languageEnglish (US)
JournalBrain Stimulation
DOIs
StateAccepted/In press - 2017

Fingerprint

Randomized Controlled Trials
Antidepressive Agents
Brain-Derived Neurotrophic Factor
Depression
Depressive Disorder
Bipolar Disorder
Genotype
Architectural Accessibility
Prefrontal Cortex
Transcranial Direct Current Stimulation
Placebos
Clinical Trials
Research
Therapeutics

Keywords

  • Brain derived neurotrophic factor
  • Depression
  • Efficacy
  • Randomized controlled trial
  • Safety
  • Transcranial direct current stimulation

ASJC Scopus subject areas

  • Neuroscience(all)
  • Biophysics
  • Clinical Neurology

Cite this

Loo, C. K., Husain, M. M., McDonald, W. M., Aaronson, S., O'Reardon, J. P., Alonzo, A., ... Lisanby, S. H. (Accepted/In press). International randomized-controlled trial of transcranial Direct Current Stimulation in depression. Brain Stimulation. https://doi.org/10.1016/j.brs.2017.10.011

International randomized-controlled trial of transcranial Direct Current Stimulation in depression. / Loo, Colleen K.; Husain, Mustafa M.; McDonald, William M.; Aaronson, Scott; O'Reardon, John P.; Alonzo, Angelo; Weickert, Cynthia Shannon; Martin, Donel M.; McClintock, Shawn M.; Mohan, Adith; Lisanby, Sarah H.

In: Brain Stimulation, 2017.

Research output: Contribution to journalArticle

Loo, CK, Husain, MM, McDonald, WM, Aaronson, S, O'Reardon, JP, Alonzo, A, Weickert, CS, Martin, DM, McClintock, SM, Mohan, A & Lisanby, SH 2017, 'International randomized-controlled trial of transcranial Direct Current Stimulation in depression', Brain Stimulation. https://doi.org/10.1016/j.brs.2017.10.011
Loo, Colleen K. ; Husain, Mustafa M. ; McDonald, William M. ; Aaronson, Scott ; O'Reardon, John P. ; Alonzo, Angelo ; Weickert, Cynthia Shannon ; Martin, Donel M. ; McClintock, Shawn M. ; Mohan, Adith ; Lisanby, Sarah H. / International randomized-controlled trial of transcranial Direct Current Stimulation in depression. In: Brain Stimulation. 2017.
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abstract = "Background: Evidence suggests that transcranial Direct Current Stimulation (tDCS) has antidepressant effects in unipolar depression, but there is limited information for patients with bipolar depression. Additionally, prior research suggests that brain derived neurotrophic factor (BDNF) Val66Met genotype may moderate response to tDCS. Objective: To examine tDCS efficacy in unipolar and bipolar depression and assess if BDNF genotype is associated with antidepressant response to tDCS. Methods: 130 participants diagnosed with a major depressive episode were randomized to receive active (2.5 milliamps (mA), 30 min) or sham (0.034 mA and two 60-second current ramps up to 1 and 0.5 mA) tDCS to the left prefrontal cortex, administered in 20 sessions over 4 weeks, in a double-blinded, international multisite study. Mixed effects repeated measures analyses assessed change in mood and neuropsychological scores in participants with at least one post-baseline rating in the unipolar (N = 84) and bipolar (N = 36) samples. Results: Mood improved significantly over the 4-week treatment period in both unipolar (p = 0.001) and bipolar groups (p < 0.001). Among participants with unipolar depression, there were more remitters in the sham treatment group (p = 0.03). There was no difference between active and sham stimulation in the bipolar sample. BDNF genotype was unrelated to antidepressant outcome. Conclusions: Overall, this study found no antidepressant difference between active and sham stimulation for unipolar or bipolar depression. However, the possibility that the low current delivered in the sham tDCS condition was biologically active cannot be discounted. Moreover, BDNF genotype did not moderate antidepressant outcome. Clinical Trials Registration: www.clinicaltrials.gov, NCT01562184.",
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AU - O'Reardon, John P.

AU - Alonzo, Angelo

AU - Weickert, Cynthia Shannon

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AU - McClintock, Shawn M.

AU - Mohan, Adith

AU - Lisanby, Sarah H.

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