Transcranial direct current stimulation for acute major depressive episodes: Meta-analysis of individual patient data

Background Transcranial direct current stimulation (tDCS) is a non-pharmacological intervention for depression. It has mixed results, possibly caused by study heterogeneity. Aims To assess tDCS efficacy and to explore individual response predictors. Method Systematic review and individual patient data meta-analysis. Results Data were gathered from six randomised sham-controlled trials, enrolling 289 patients. Active tDCS was significantly superior to sham for response (34% v. 19% respectively, odds ratio (OR) = 2.44, 95% CI 1.38–4.32, number needed to treat (NNT) = 7), remission (23.1% v. 12.7% respectively, OR = 2.38, 95% CI 1.22–4.64, NNT = 9) and depression improvement (B coefficient 0.35, 95% CI 0.12–0.57). Mixed-effects models showed that, after adjustment for other predictors and confounders, treatment-resistant depression and higher tDCS ‘doses' were, respectively, negatively and positively associated with tDCS efficacy. Conclusions The effect size of tDCS treatment was comparable with those reported for repetitive transcranial magnetic stimulation and antidepressant drug treatment in primary care. The most important parameters for optimisation in future trials are depression refractoriness and tDCS dose.

[1]  E. Haffen,et al.  Pilot study of feasibility of the effect of treatment with tDCS in patients suffering from treatment-resistant depression treated with escitalopram , 2015, Clinical Neurophysiology.

[2]  J. Markowitz,et al.  The 16-Item quick inventory of depressive symptomatology (QIDS), clinician rating (QIDS-C), and self-report (QIDS-SR): a psychometric evaluation in patients with chronic major depression , 2003, Biological Psychiatry.

[3]  Paul B. Fitzgerald,et al.  A Randomized Double-Blind Sham-Controlled Study of Transcranial Direct Current Stimulation for Treatment-Resistant Major Depression , 2012, Front. Psychiatry.

[4]  K. Kedzior,et al.  More female patients and fewer stimuli per session are associated with the short-term antidepressant properties of repetitive transcranial magnetic stimulation (rTMS): a meta-analysis of 54 sham-controlled studies published between 1997–2013 , 2014, Neuropsychiatric disease and treatment.

[5]  J. Ioannidis,et al.  The PRISMA Statement for Reporting Systematic Reviews and Meta-Analyses of Studies That Evaluate Health Care Interventions: Explanation and Elaboration , 2009, Annals of Internal Medicine [serial online].

[6]  Donel M. Martin,et al.  Transcranial direct current stimulation for depression: 3-week, randomised, sham-controlled trial , 2012, British Journal of Psychiatry.

[7]  Sarah H Lisanby,et al.  Daily left prefrontal transcranial magnetic stimulation therapy for major depressive disorder: a sham-controlled randomized trial. , 2010, Archives of general psychiatry.

[8]  B. Lebowitz,et al.  Medication augmentation after the failure of SSRIs for depression. , 2006, The New England journal of medicine.

[9]  N. D. Morton The PEDro scale is a valid measure of the methodological quality of clinical trials: a demographic study. , 2009 .

[10]  S H Lisanby,et al.  A prospective, randomized, double-blind comparison of bilateral and right unilateral electroconvulsive therapy at different stimulus intensities. , 2000, Archives of general psychiatry.

[11]  Maurizio Fava,et al.  Bupropion-SR, sertraline, or venlafaxine-XR after failure of SSRIs for depression. , 2006, The New England journal of medicine.

[12]  Felipe Fregni,et al.  Transcranial direct current stimulation for the treatment of major depressive disorder: A summary of preclinical, clinical and translational findings , 2012, Progress in Neuro-Psychopharmacology and Biological Psychiatry.

[13]  Mark C Simmonds,et al.  Meta-analysis of individual patient data from randomized trials: a review of methods used in practice , 2005, Clinical trials.

[14]  M. Posternak,et al.  Implications of using different cut-offs on symptom severity scales to define remission from depression , 2004, International Clinical Psychopharmacology.

[15]  Sergio P. Rigonatti,et al.  Predictors of antidepressant response in clinical trials of transcranial magnetic stimulation. , 2006, The international journal of neuropsychopharmacology.

[16]  H. Sackeim,et al.  Daily Left Prefrontal Repetitive Transcranial Magnetic Stimulation in the Acute Treatment of Major Depression: Clinical Predictors of Outcome in a Multisite, Randomized Controlled Clinical Trial , 2009, Neuropsychopharmacology.

[17]  Gin S Malhi,et al.  A double-blind, sham-controlled trial of transcranial direct current stimulation for the treatment of depression. , 2010, The international journal of neuropsychopharmacology.

[18]  F. Fregni,et al.  Transcranial direct current stimulation for major depression: an updated systematic review and meta-analysis. , 2014, The international journal of neuropsychopharmacology.

[19]  H. Möller,et al.  Transcranial direct current stimulation in treatment resistant depression: A randomized double-blind, placebo-controlled study , 2012, Brain Stimulation.

[20]  F. Fregni,et al.  The sertraline vs. electrical current therapy for treating depression clinical study: results from a factorial, randomized, controlled trial. , 2013, JAMA psychiatry.

[21]  I. Benseñor,et al.  Impact of Two or Less Missing Treatment Sessions on tDCS Clinical Efficacy: Results From a Factorial, Randomized, Controlled Trial in Major Depression , 2014, Neuromodulation (Malden, Mass.).

[22]  Z. Daskalakis,et al.  Clinical utility of transcranial direct current stimulation (tDCS) for treating major depression: a systematic review and meta-analysis of randomized, double-blind and sham-controlled trials. , 2013, Journal of psychiatric research.

[23]  P. Mitchell,et al.  Continuation transcranial direct current stimulation for the prevention of relapse in major depression. , 2013, Journal of Affective Disorders.

[24]  D. Moher,et al.  Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. , 2010, International journal of surgery.

[25]  M. Nitsche,et al.  Serotonin Affects Transcranial Direct Current–Induced Neuroplasticity in Humans , 2009, Biological Psychiatry.

[26]  P. Schestatsky,et al.  Comparison of blinding effectiveness between sham tDCS and placebo sertraline in a 6-week major depression randomized clinical trial , 2014, Clinical Neurophysiology.

[27]  Á. Pascual-Leone,et al.  A randomized, double-blind clinical trial on the efficacy of cortical direct current stimulation for the treatment of major depression. , 2008, The international journal of neuropsychopharmacology.

[28]  L. Merabet,et al.  Clinical research with transcranial direct current stimulation (tDCS): Challenges and future directions , 2012, Brain Stimulation.

[29]  Z. Daskalakis,et al.  Response, remission and drop-out rates following high-frequency repetitive transcranial magnetic stimulation (rTMS) for treating major depression: a systematic review and meta-analysis of randomized, double-blind and sham-controlled trials , 2013, Psychological Medicine.

[30]  F. Fregni,et al.  THE SERTRALINE VERSUS ELECTRICAL CURRENT THERAPY FOR TREATING DEPRESSION CLINICAL STUDY (SELECT‐TDCS): RESULTS OF THE CROSSOVER AND FOLLOW‐UP PHASES , 2013, Depression and anxiety.

[31]  Klaus P. Ebmeier,et al.  Transcranial direct current stimulation in the treatment of major depression: a meta-analysis , 2012, Psychological Medicine.

[32]  N. D. de Morton The PEDro scale is a valid measure of the methodological quality of clinical trials: a demographic study. , 2009, The Australian journal of physiotherapy.

[33]  M. Nitsche,et al.  Physiological Basis of Transcranial Direct Current Stimulation , 2011, The Neuroscientist : a review journal bringing neurobiology, neurology and psychiatry.

[34]  Evangelos Kontopantelis,et al.  A Short Guide and a Forest Plot Command (Ipdforest) for One-Stage Meta-Analysis , 2012 .

[35]  Hendrik Koffijberg,et al.  Individual Participant Data Meta-Analysis for a Binary Outcome: One-Stage or Two-Stage? , 2013, PloS one.

[36]  F. Fregni,et al.  Interactions between transcranial direct current stimulation (tDCS) and pharmacological interventions in the Major Depressive Episode: Findings from a naturalistic study , 2013, European Psychiatry.

[37]  Michele Tarsilla Cochrane Handbook for Systematic Reviews of Interventions , 2010, Journal of MultiDisciplinary Evaluation.

[38]  R. Baldessarini,et al.  Randomized, Placebo-Controlled Trials of Antidepressants for Acute Major Depression: Thirty-Year Meta-Analytic Review , 2012, Neuropsychopharmacology.

[39]  M. Keller,et al.  Past, present, and future directions for defining optimal treatment outcome in depression: remission and beyond. , 2003, JAMA.

[40]  S. Rossi,et al.  Evidence-based guidelines on the therapeutic use of repetitive transcranial magnetic stimulation (rTMS) , 2014, Clinical Neurophysiology.

[41]  Grant Blashki,et al.  Antidepressants versus placebo for depression in primary care. , 2009, The Cochrane database of systematic reviews.

[42]  Blair T. Johnson,et al.  Initial Severity and Antidepressant Benefits: A Meta-Analysis of Data Submitted to the Food and Drug Administration , 2008, PLoS medicine.