Colleen K Loo1, Mustafa M Husain2, William M McDonald3, Scott Aaronson4, John P O'Reardon5, Angelo Alonzo6, Cynthia Shannon Weickert7, Donel M Martin6, Shawn M McClintock2, Adith Mohan8, Sarah H Lisanby9. 1. 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. 2. 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. 3. Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, 12 Executive Park Dr NE #200, Atlanta, GA 30329, USA. 4. Sheppard Pratt Health System, Clinical Research Programs, 6501 N. Charles Street, Suite A319, Baltimore, MD 21204, USA. 5. Rowan University School of Osteopathic Medicine, 2250 Chapel Ave W, Cherry Hill, NJ 08034, USA. 6. School of Psychiatry, University of New South Wales, Black Dog Institute, Hospital Road, Randwick, Sydney, NSW 2031, Australia. 7. 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. 8. Neuroscience Research Australia, Margarete Ainsworth Building, Barker Street, Randwick, Sydney, NSW 2031, Australia. 9. Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Duke South 5th Floor Red Zone, DUMC Box 3620, Durham, NC 27710, USA.
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.
RCT Entities:
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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