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Treatment of Bipolar Depression with Deep TMS: Results from a Double-Blind, Randomized, Parallel Group, Sham-Controlled Clinical Trial.
Tavares, Diego F; Myczkowski, Martin L; Alberto, Rodrigo L; Valiengo, Leandro; Rios, Rosa M; Gordon, Pedro; de Sampaio-Junior, Bernardo; Klein, Izio; Mansur, Carlos G; Marcolin, Marco Antonio; Lafer, Beny; Moreno, Ricardo A; Gattaz, Wagner; Daskalakis, Zafiris J; Brunoni, André R.
Afiliación
  • Tavares DF; Service of Interdisciplinary Neuromodulation (SIN-EMT), Department and Institute of Psychiatry, Faculty of Medicine, University of São Paulo, São Paulo, Brazil.
  • Myczkowski ML; Mood Disorders Unit (GRUDA), Department and Institute of Psychiatry, Faculty of Medicine, University of São Paulo, São Paulo, Brazil.
  • Alberto RL; Service of Interdisciplinary Neuromodulation (SIN-EMT), Department and Institute of Psychiatry, Faculty of Medicine, University of São Paulo, São Paulo, Brazil.
  • Valiengo L; Service of Interdisciplinary Neuromodulation (SIN-EMT), Department and Institute of Psychiatry, Faculty of Medicine, University of São Paulo, São Paulo, Brazil.
  • Rios RM; Service of Interdisciplinary Neuromodulation (SIN-EMT), Department and Institute of Psychiatry, Faculty of Medicine, University of São Paulo, São Paulo, Brazil.
  • Gordon P; Laboratory of Neuroscience (LIM27), Department and Institute of Psychiatry, University of São Paulo, São Paulo, Brazil.
  • de Sampaio-Junior B; Service of Interdisciplinary Neuromodulation (SIN-EMT), Department and Institute of Psychiatry, Faculty of Medicine, University of São Paulo, São Paulo, Brazil.
  • Klein I; Service of Interdisciplinary Neuromodulation (SIN-EMT), Department and Institute of Psychiatry, Faculty of Medicine, University of São Paulo, São Paulo, Brazil.
  • Mansur CG; Service of Interdisciplinary Neuromodulation (SIN-EMT), Department and Institute of Psychiatry, Faculty of Medicine, University of São Paulo, São Paulo, Brazil.
  • Marcolin MA; University Hospital, University of São Paulo, São Paulo, Brazil.
  • Lafer B; Service of Interdisciplinary Neuromodulation (SIN-EMT), Department and Institute of Psychiatry, Faculty of Medicine, University of São Paulo, São Paulo, Brazil.
  • Moreno RA; University Hospital, University of São Paulo, São Paulo, Brazil.
  • Gattaz W; Service of Interdisciplinary Neuromodulation (SIN-EMT), Department and Institute of Psychiatry, Faculty of Medicine, University of São Paulo, São Paulo, Brazil.
  • Daskalakis ZJ; Department and Institute of Neurology, Faculty of Medicine, University of São Paulo, São Paulo, Brazil.
  • Brunoni AR; Service of Interdisciplinary Neuromodulation (SIN-EMT), Department and Institute of Psychiatry, Faculty of Medicine, University of São Paulo, São Paulo, Brazil.
Neuropsychopharmacology ; 42(13): 2593-2601, 2017 Dec.
Article en En | MEDLINE | ID: mdl-28145409
Bipolar depression (BD) is a highly prevalent condition with limited therapeutic options. Deep (H1-coil) transcranial magnetic stimulation (dTMS) is a novel TMS modality with established efficacy for unipolar depression. We conducted a randomized sham-controlled trial to evaluate the efficacy and safety of dTMS in treatment-resistant BD patients. Patients received 20 sessions of active or sham dTMS over the left dorsolateral prefrontal cortex (H1-coil, 55 18 Hz 2 s 120% MT trains). The primary outcome was changes in the 17-item Hamilton Depression Rating Scale (HDRS-17) from baseline to endpoint (week 4). Secondary outcomes were changes from baseline to the end of the follow-up phase (week 8), and response and remission rates. Safety was assessed using a dTMS adverse effects questionnaire and the Young Mania Rating Scale to assess treatment-emergent mania switch (TEMS). Out of 50 patients, 43 finished the trial. There were 2 and 5 dropouts in the sham and active groups, respectively. Active dTMS was superior to sham at end point (difference favoring dTMS=4.88; 95% CI 0.43 to 9.32, p=0.03) but not at follow-up. There was also a trend for greater response rates in the active (48%) vs sham (24%) groups (OR=2.92; 95% CI=0.87 to 9.78, p=0.08). Remission rates were not statistically different. No TEMS episodes were observed. Deep TMS is a potentially effective and well-tolerated add-on therapy in resistant bipolar depressed patients receiving adequate pharmacotherapy.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Trastorno Bipolar / Estimulación Magnética Transcraneal Tipo de estudio: Clinical_trials / Observational_studies / Prognostic_studies Límite: Adult / Female / Humans / Male Idioma: En Revista: Neuropsychopharmacology Asunto de la revista: NEUROLOGIA / PSICOFARMACOLOGIA Año: 2017 Tipo del documento: Article País de afiliación: Brasil Pais de publicación: Reino Unido
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Trastorno Bipolar / Estimulación Magnética Transcraneal Tipo de estudio: Clinical_trials / Observational_studies / Prognostic_studies Límite: Adult / Female / Humans / Male Idioma: En Revista: Neuropsychopharmacology Asunto de la revista: NEUROLOGIA / PSICOFARMACOLOGIA Año: 2017 Tipo del documento: Article País de afiliación: Brasil Pais de publicación: Reino Unido