PMID- 29111077 OWN - NLM STAT- MEDLINE DCOM- 20180718 LR - 20220408 IS - 1876-4754 (Electronic) IS - 1876-4754 (Linking) VI - 11 IP - 1 DP - 2018 Jan-Feb TI - International randomized-controlled trial of transcranial Direct Current Stimulation in depression. PG - 125-133 LID - S1935-861X(17)30944-0 [pii] LID - 10.1016/j.brs.2017.10.011 [doi] AB - 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. CI - Copyright (c) 2017 Elsevier Inc. All rights reserved. FAU - Loo, Colleen K AU - Loo CK AD - School of Psychiatry, University of New South Wales, Black Dog Institute, Hospital Road, Randwick, Sydney, NSW 2031, Australia. Electronic address: colleen.loo@unsw.edu.au. FAU - Husain, Mustafa M AU - Husain MM AD - Department of Psychiatry, UT Southwestern Medical Center, 5323 Harry Hines Blvd, Dallas, TX 75390, USA; Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Duke South 5th Floor Red Zone, DUMC Box 3620, Durham, NC 27710, USA. FAU - McDonald, William M AU - McDonald WM AD - Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, 12 Executive Park Dr NE #200, Atlanta, GA 30329, USA. FAU - Aaronson, Scott AU - Aaronson S AD - Sheppard Pratt Health System, Clinical Research Programs, 6501 N. Charles Street, Suite A319, Baltimore, MD 21204, USA. FAU - O'Reardon, John P AU - O'Reardon JP AD - Rowan University School of Osteopathic Medicine, 2250 Chapel Ave W, Cherry Hill, NJ 08034, USA. FAU - Alonzo, Angelo AU - Alonzo A AD - School of Psychiatry, University of New South Wales, Black Dog Institute, Hospital Road, Randwick, Sydney, NSW 2031, Australia. FAU - Weickert, Cynthia Shannon AU - Weickert CS AD - Neuroscience Research Australia, Margarete Ainsworth Building, Barker Street, Randwick, Sydney, NSW 2031, Australia; School of Psychiatry, Faculty of Medicine, University of New South Wales, Sydney, NSW 2052, Australia. FAU - Martin, Donel M AU - Martin DM AD - School of Psychiatry, University of New South Wales, Black Dog Institute, Hospital Road, Randwick, Sydney, NSW 2031, Australia. FAU - McClintock, Shawn M AU - McClintock SM AD - Department of Psychiatry, UT Southwestern Medical Center, 5323 Harry Hines Blvd, Dallas, TX 75390, USA; Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Duke South 5th Floor Red Zone, DUMC Box 3620, Durham, NC 27710, USA. FAU - Mohan, Adith AU - Mohan A AD - Neuroscience Research Australia, Margarete Ainsworth Building, Barker Street, Randwick, Sydney, NSW 2031, Australia. FAU - Lisanby, Sarah H AU - Lisanby SH AD - Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Duke South 5th Floor Red Zone, DUMC Box 3620, Durham, NC 27710, USA. CN - International Consortium of Research in tDCS (ICRT) LA - eng SI - ClinicalTrials.gov/NCT01562184 PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20171027 PL - United States TA - Brain Stimul JT - Brain stimulation JID - 101465726 RN - 0 (Brain-Derived Neurotrophic Factor) RN - 7171WSG8A2 (BDNF protein, human) SB - IM MH - Adolescent MH - Adult MH - Aged MH - Aged, 80 and over MH - Bipolar Disorder/genetics/*therapy MH - Brain-Derived Neurotrophic Factor/genetics MH - Depression/genetics/*therapy MH - Depressive Disorder, Major/genetics/*therapy MH - Double-Blind Method MH - Female MH - Humans MH - Male MH - Middle Aged MH - Prefrontal Cortex/physiology/physiopathology MH - *Transcranial Direct Current Stimulation MH - Treatment Outcome MH - Young Adult OTO - NOTNLM OT - Brain derived neurotrophic factor OT - Depression OT - Efficacy OT - Randomized controlled trial OT - Safety OT - Transcranial direct current stimulation FIR - Lisanby, Sarah H IR - Lisanby SH IRAD- Duke University, USA. FIR - Krystal, Andrew D IR - Krystal AD IRAD- Duke University, USA. FIR - Peterchev, Angel V IR - Peterchev AV IRAD- Duke University, USA. FIR - McDonald, William M IR - McDonald WM IRAD- Emory University, USA. FIR - O'Reardon, John P IR - O'Reardon JP IRAD- Rowan University, USA. FIR - Aaronson, Scott IR - Aaronson S IRAD- Sheppard Pratt Health System, USA. FIR - Davis, Whitney IR - Davis W IRAD- Sheppard Pratt Health System, USA. FIR - Sklar, Jennifer IR - Sklar J IRAD- Sheppard Pratt Health System, USA. FIR - Loo, Colleen K IR - Loo CK IRAD- University of New South Wales, Australia. FIR - Alonzo, Angelo IR - Alonzo A IRAD- University of New South Wales, Australia. FIR - Weickert, Cyndi S IR - Weickert CS IRAD- University of New South Wales, Australia. FIR - Martin, Donel M IR - Martin DM IRAD- University of New South Wales, Australia. FIR - Mohan, Adith IR - Mohan A IRAD- University of New South Wales, Australia. FIR - Colagiuri, Ben IR - Colagiuri B IRAD- University of New South Wales, Australia. FIR - Galvez, Veronica IR - Galvez V IRAD- University of New South Wales, Australia. FIR - Husain, Mustafa M IR - Husain MM IRAD- University of Texas Southwestern, USA. FIR - McClintock, Shawn M IR - McClintock SM IRAD- University of Texas Southwestern, USA. EDAT- 2017/11/08 06:00 MHDA- 2018/07/19 06:00 CRDT- 2017/11/08 06:00 PHST- 2017/04/28 00:00 [received] PHST- 2017/09/18 00:00 [revised] PHST- 2017/10/15 00:00 [accepted] PHST- 2017/11/08 06:00 [pubmed] PHST- 2018/07/19 06:00 [medline] PHST- 2017/11/08 06:00 [entrez] AID - S1935-861X(17)30944-0 [pii] AID - 10.1016/j.brs.2017.10.011 [doi] PST - ppublish SO - Brain Stimul. 2018 Jan-Feb;11(1):125-133. doi: 10.1016/j.brs.2017.10.011. Epub 2017 Oct 27.