Home-based transcranial direct current stimulation treatment for major depressive disorder: a fully remote phase 2 randomized sham-controlled trial.

Autor: Woodham RD; School of Psychology, University of East London, London, UK., Selvaraj S; Center of Excellence on Mood Disorders, Faillace Department of Psychiatry and Behavioral Sciences, McGovern Medical School, University of Texas Health Science Center at Houston, Houston, TX, USA.; Intra-Cellular Therapies Inc, New York, NY, USA., Lajmi N; School of Psychology, University of East London, London, UK., Hobday H; School of Psychology, University of East London, London, UK., Sheehan G; School of Psychology, University of East London, London, UK., Ghazi-Noori AR; School of Psychology, University of East London, London, UK., Lagerberg PJ; School of Psychology, University of East London, London, UK., Rizvi M; Center of Excellence on Mood Disorders, Faillace Department of Psychiatry and Behavioral Sciences, McGovern Medical School, University of Texas Health Science Center at Houston, Houston, TX, USA., Kwon SS; Center of Excellence on Mood Disorders, Faillace Department of Psychiatry and Behavioral Sciences, McGovern Medical School, University of Texas Health Science Center at Houston, Houston, TX, USA., Orhii P; Center of Excellence on Mood Disorders, Faillace Department of Psychiatry and Behavioral Sciences, McGovern Medical School, University of Texas Health Science Center at Houston, Houston, TX, USA.; Paul L. Foster School of Medicine, Texas Tech University Health Sciences Center at El Paso, El Paso, TX, USA., Maislin D; Biomedical Statistical Consulting, Philadelphia, PA, USA., Hernandez L; Biomedical Statistical Consulting, Philadelphia, PA, USA., Machado-Vieira R; Center of Excellence on Mood Disorders, Faillace Department of Psychiatry and Behavioral Sciences, McGovern Medical School, University of Texas Health Science Center at Houston, Houston, TX, USA., Soares JC; Center of Excellence on Mood Disorders, Faillace Department of Psychiatry and Behavioral Sciences, McGovern Medical School, University of Texas Health Science Center at Houston, Houston, TX, USA., Young AH; Centre for Affective Disorders, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.; National Institute for Health Research, Biomedical Research Centre at South London and Maudsley NHS Foundation Trust, King's College London, London, UK.; South London and Maudsley NHS Foundation Trust, Bethlem Royal Hospital, Beckenham, UK., Fu CHY; School of Psychology, University of East London, London, UK. cynthia.fu@kcl.ac.uk.; Centre for Affective Disorders, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK. cynthia.fu@kcl.ac.uk.
Jazyk: angličtina
Zdroj: Nature medicine [Nat Med] 2024 Oct 21. Date of Electronic Publication: 2024 Oct 21.
DOI: 10.1038/s41591-024-03305-y
Abstrakt: Transcranial direct current stimulation (tDCS) has been proposed as a new treatment in major depressive disorder (MDD). This is a fully remote, multisite, double-blind, placebo-controlled, randomized superiority trial of 10-week home-based tDCS in MDD. Participants were 18 years or older, with MDD in current depressive episode of at least moderate severity as measured using the Hamilton Depression Rating Scale (mean = 19.07 ± 2.73). A total of 174 participants (120 women, 54 men) were randomized to active (n = 87, mean age = 37.09 ± 11.14 years) or sham (n = 87, mean age = 38.32 ± 10.92 years) treatment. tDCS consisted of five sessions per week for 3 weeks then three sessions per week for 7 weeks in a 10-week trial, followed by a 10-week open-label phase. Each session lasted 30 min; the anode was placed over the left dorsolateral prefrontal cortex and the cathode over the right dorsolateral prefrontal cortex (active tDCS 2 mA and sham tDCS 0 mA, with brief ramp up and down to mimic active stimulation). As the primary outcome, depressive symptoms showed significant improvement when measured using the Hamilton Depression Rating Scale: active 9.41 ± 6.25 point improvement (10-week mean = 9.58 ± 6.02) and sham 7.14 ± 6.10 point improvement (10-week mean = 11.66 ± 5.96) (95% confidence interval = 0.51-4.01, P = 0.012). There were no differences in discontinuation rates. In summary, a 10-week home-based tDCS treatment with remote supervision in MDD showed high efficacy, acceptability and safety. ClinicalTrials.gov registration: NCT05202119.
(© 2024. The Author(s).)
Databáze: MEDLINE
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