The Escitalopram versus Electric Current Therapy for Treating Depression Clinical Study (ELECT-TDCS): rationale and study design of a non-inferiority, triple-arm, placebo-controlled clinical trial

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art_BRUNONI_The_Escitalopram_versus_Electric_Current_Therapy_for_Treating_2015.PDF (1.17 MB)
Citações na Scopus
50
Tipo de produção
article
Data de publicação
2015
DOI
SciELO
Scopus
Web of Science
PubMed
Título da Revista
ISSN da Revista
Título do Volume
Editora
ASSOCIACAO PAULISTA MEDICINA
Autores
MOFFA, Adriano Henrique
NOGUEIRA, Barbara Schwair
APARICIO, Luana Vanessa Marotti
VERONEZI, Beatriz
FERNANDES, Raquel Albano
Citação
SAO PAULO MEDICAL JOURNAL, v.133, n.3, p.252-263, 2015
Projetos de Pesquisa
Unidades Organizacionais
Fascículo
Resumo
CONTEXT AND OBJECTIVE: Major depressive disorder (MDD) is a common psychiatric condition, mostly treated with antidepressant drugs, which are limited due to refractoriness and adverse effects. We describe the study rationale and design of ELECT-TDCS (Escitalopram versus Electric Current Therapy for Treating Depression Clinical Study), which is investigating a non-pharmacological treatment known as transcranial direct current stimulation (tDCS). DESIGN AND SETTING: Phase-III, randomized, non-inferiority, triple-arm, placebo-controlled study, ongoing in Sao Paulo, Brazil. METHODS: ELECT-TDCS compares the efficacy of active tDCS/placebo pill, sham tDCS/escitalopram 20 mg/day and sham tDCS/placebo pill, for ten weeks, randomizing 240 patients in a 3: 3: 2 ratio, respectively. Our primary aim is to show that tDCS is not inferior to escitalopram with a non-inferiority margin of at least 50% of the escitalopram effect, in relation to placebo. As secondary aims, we investigate several biomarkers such as genetic polymorphisms, neurotrophin serum markers, motor cortical excitability, heart rate variability and neuroimaging. RESULTS: Proving that tDCS is similarly effective to antidepressants would have a tremendous impact on clinical psychiatry, since tDCS is virtually devoid of adverse effects. Its ease of use, portability and low price are further compelling characteristics for its use in primary and secondary healthcare. Multimodal investigation of biomarkers will also contribute towards understanding the antidepressant mechanisms of action of tDCS. CONCLUSION: Our results have the potential to introduce a novel technique to the therapeutic arsenal of treatments for depression.
Palavras-chave
Depressive disorder, major, Electric stimulation therapy, Citalopram, Randomized controlled trial, Biological markers
URI
https://observatorio.fm.usp.br/handle/OPI/11783
Referências
  1. Anderson IM, 2008, J PSYCHOPHARMACOL, V22, P343, DOI 10.1177/0269881107088441
  2. [Anonymous], 2010, GUIDANCE IND NONFERI
  3. Arul-Anandam AP, 2010, J ECT, V26, P68, DOI 10.1097/YCT.0b013e3181a744bf
  4. Baccaro A, 2010, ACTA NEUROPSYCHIATR, V22, P316, DOI 10.1111/j.1601-5215.2010.00495.x
  5. Bajbouj M, 2006, BIOL PSYCHIAT, V59, P395, DOI 10.1016/j.biopsych.2005.07.036
  6. Batsikadze G, 2013, J PHYSIOL-LONDON, V591, P1987, DOI 10.1113/jphysiol.2012.249730
  7. Binkley N, 2012, J BONE MINER RES, V27, P1821, DOI 10.1002/jbmr.1602
  8. Blumberger Daniel M, 2012, Front Psychiatry, V3, P74, DOI 10.3389/fpsyt.2012.00074
  9. Bocchio-Chiavetto L, 2010, WORLD J BIOL PSYCHIA, V11, P763, DOI 10.3109/15622971003611319
  10. Bocchio-Chiavetto L, 2008, NEUROSCI LETT, V437, P130, DOI 10.1016/j.neulet.2008.04.005
  11. Bora E, 2012, J AFFECT DISORDERS, V138, P9, DOI 10.1016/j.jad.2011.03.049
  12. Bromet E, 2011, BMC MED, V9, DOI 10.1186/1741-7015-9-90
  13. Brunoni AR, 2012, PROG NEURO-PSYCHOPH, V39, P9, DOI 10.1016/j.pnpbp.2012.05.016
  14. Brunoni AR, 2013, INT J NEUROPSYCHOPH, V16, P1937, DOI 10.1017/S1461145713000497
  15. Brunoni AR, 2008, INT J NEUROPSYCHOPH, V11, P1169, DOI 10.1017/S1461145708009309
  16. Brunoni AR, 2014, CLIN NEUROPHYSIOL, V125, P298, DOI 10.1016/j.clinph.2013.07.020
  17. Brunoni AR, 2013, JAMA PSYCHIAT, V70, P383, DOI 10.1001/2013.jamapsychiatry.32
  18. Brunoni AR, 2015, PROG NEURO-PSYCHOPH, V56, P91, DOI 10.1016/j.pnpbp.2014.08.009
  19. Brunoni AR, 2013, EUR NEUROPSYCHOPHARM, V23, P1530, DOI 10.1016/j.euroneuro.2013.03.009
  20. Brunoni AR, 2011, INT J NEUROPSYCHOPH, V14, P1133, DOI 10.1017/S1461145710001690
  21. Brunoni AR, 2012, BRAIN STIMUL, V5, P175, DOI 10.1016/j.brs.2011.03.002
  22. Brunoni AR, 2011, J NEUROPSYCH CLIN N, V23, pE4, DOI 10.1176/appi.neuropsych.23.3.E4
  23. Brunoni AR, 2011, CONTEMP CLIN TRIALS, V32, P90, DOI 10.1016/j.cct.2010.09.007
  24. Brunoni AR, 2014, EUR NEUROPSYCHOPHARM, V24, P1144, DOI 10.1016/j.euroneuro.2014.03.006
  25. Brunoni AR, 2014, WORLD J BIOL PSYCHIA, V15, P411, DOI 10.3109/15622975.2014.892633
  26. Cipriani A, 2009, LANCET, V373, P746, DOI 10.1016/S0140-6736(09)60046-5
  27. Crisafulli C, 2011, FRONT PHARMACOL, V2, DOI 10.3389/fphar.2011.00006
  28. Croarkin PE, 2013, JAMA PSYCHIAT, V70, P291, DOI 10.1001/2013.jamapsychiatry.24
  29. Domschke K, 2010, INT J NEUROPSYCHOPH, V13, P93, DOI 10.1017/S1461145709000030
  30. Du LS, 2000, AM J MED GENET, V96, P56, DOI 10.1002/(SICI)1096-8628(20000207)96:1<56::AID-AJMG12>3.0.CO;2-L
  31. Du MY, 2012, PROG NEURO-PSYCHOPH, V36, P11, DOI 10.1016/j.pnpbp.2011.09.014
  32. European Medicines Agency, 2004, PREAUTH EV MED HUM U
  33. Ferrucci R., 2009, CLIN NEUROPSYCHIATRY, V6, P246
  34. Fregni F, 2006, BIPOLAR DISORD, V8, P203, DOI 10.1111/j.1399-5618.2006.00291.x
  35. Galvez V, 2011, J ECT, V27, P256, DOI 10.1097/YCT.0b013e3182012b89
  36. Gamalo MA, 2013, STAT METHODS MED RES, V22, P261, DOI 10.1177/0962280210395739
  37. Gandiga PC, 2006, CLIN NEUROPHYSIOL, V117, P845, DOI 10.1016/j.clinph.2005.12.003
  38. George MS, 2010, ARCH GEN PSYCHIAT, V67, P507, DOI 10.1001/archgenpsychiatry.2010.46
  39. Hasler G, 2011, MOL PSYCHIATR, V16, P604, DOI 10.1038/mp.2011.23
  40. Huitfeldt B, 2011, PHARM STAT, V10, P414, DOI 10.1002/pst.508
  41. Jonsson EG, 1997, EUR ARCH PSY CLIN N, V247, P297, DOI 10.1007/BF02922258
  42. Kato M, 2010, MOL PSYCHIATR, V15, P473, DOI 10.1038/mp.2008.116
  43. Kemp AH, 2014, AM J PSYCHIAT, V171, P1328, DOI 10.1176/appi.ajp.2014.13121605
  44. Kemp AH, 2010, BIOL PSYCHIAT, V67, P1067, DOI 10.1016/j.biopsych.2009.12.012
  45. Knotkova Helena, 2012, Front Psychiatry, V3, P59, DOI 10.3389/fpsyt.2012.00059
  46. Kobayashi M, 2003, LANCET NEUROL, V2, P145, DOI 10.1016/S1474-4422(03)00321-1
  47. Koch Armin, 2004, J Biopharm Stat, V14, P315, DOI 10.1081/BIP-120037182
  48. Kozel FA, 2011, J ECT, V27, P5, DOI 10.1097/YCT.0b013e3181e6317d
  49. Kuipers SD, 2003, J NEUROCHEM, V85, P1312, DOI 10.1046/j.1471-4159.2003.01770.x
  50. Lai CH, 2013, PSYCHIAT RES-NEUROIM, V211, P37, DOI 10.1016/j.pscychresns.2012.06.006
  51. Levinson AJ, 2010, BIOL PSYCHIAT, V67, P458, DOI 10.1016/j.biopsych.2009.09.025
  52. Liao Y, 2013, J PSYCHIATR NEUROSCI, V38, P49, DOI 10.1503/jpn.110180
  53. Loo CK, 2010, INT J NEUROPSYCHOPH, V13, P61, DOI 10.1017/S1461145709990411
  54. Loo CK, 2012, BRIT J PSYCHIAT, V200, P52, DOI 10.1192/bjp.bp.111.097634
  55. Malaguti A, 2011, DEPRESS ANXIETY, V28, P568, DOI 10.1002/da.20815
  56. Mayberg HS, 2000, BIOL PSYCHIAT, V48, P830, DOI 10.1016/S0006-3223(00)01036-2
  57. McMahon FJ, 2006, AM J HUM GENET, V78, P804, DOI 10.1086/503820
  58. Middleton H, 2005, BRIT MED J, V330, P267, DOI 10.1136/bmj.330.7486.267
  59. Moffa AH, 2014, REV PSIQ CLIN-BRAZIL, V41, P15, DOI 10.1590/0101-60830004111520
  60. Molendijk ML, 2014, MOL PSYCHIATR, V19, P791, DOI 10.1038/mp.2013.105
  61. Mulla SM, 2012, JAMA-J AM MED ASSOC, V308, P2605, DOI 10.1001/2012.jama.11235
  62. Murray CJL, 1997, LANCET, V349, P1498, DOI 10.1016/S0140-6736(96)07492-2
  63. Nitsche MA, 2008, BRAIN STIMUL, V1, P206, DOI 10.1016/j.brs.2008.06.004
  64. Nitsche MA, 2000, J PHYSIOL-LONDON, V527, P633, DOI 10.1111/j.1469-7793.2000.t01-1-00633.x
  65. Nutt D, 2008, J PSYCHOPHARMACOL, V22, P409, DOI 10.1177/0269881108091068
  66. Oliveira JF, 2013, NEUROSCI LETT, V537, P60, DOI 10.1016/j.neulet.2013.01.023
  67. Palm U, 2012, BRAIN STIMUL, V5, P242, DOI 10.1016/j.brs.2011.08.005
  68. Palm U, 2013, J AFFECT DISORDERS, V150, P659, DOI 10.1016/j.jad.2013.03.015
  69. Pahn U, 2008, BRAIN STIMUL, V1, P386, DOI 10.1016/j.brs.2008.04.003
  70. Peng HJ, 2012, J AFFECT DISORDERS, V136, P249, DOI 10.1016/j.jad.2011.12.006
  71. Pigeot I, 2003, STAT MED, V22, P883, DOI 10.1002/sim.1450
  72. Player MJ, 2014, J AFFECT DISORDERS, V167, P140, DOI 10.1016/j.jad.2014.05.063
  73. Posner J, 2013, JAMA PSYCHIAT, V70, P373, DOI 10.1001/jamapsychiatry.2013.455
  74. Powell TY, 2014, PLOS ONE, V9, DOI 10.1371/journal.pone.0098503
  75. Priori A, 2009, BRAIN STIMUL, V2, P241, DOI 10.1016/j.brs.2009.02.004
  76. PURPURA DP, 1965, J NEUROPHYSIOL, V28, P166
  77. RABKIN JG, 1992, J CLIN PSYCHOPHARM, V12, P3
  78. RADMAN T, 2009, BRAIN STIMUL, V2, P215, DOI 10.1016/J.BRS.2009.03.007
  79. Rahman A, 2013, J PHYSIOL-LONDON, V591, P2563, DOI 10.1113/jphysiol.2012.247171
  80. Rosa MA, 2012, NEUROPSYCHOPHARMACOL, V37, P102, DOI 10.1038/npp.2011.225
  81. Rothmann MD, 2012, CH CRC BIOSTAT SER, P1
  82. Rush AJ, 2006, AM J PSYCHIAT, V163, P1905, DOI 10.1176/appi.ajp.163.11.1905
  83. Schutter DJLG, 2009, PSYCHOL MED, V39, P65, DOI 10.1017/S0033291708003462
  84. Schutter DJLG, 2010, PSYCHOL MED, V40, P1789, DOI 10.1017/S003329171000005X
  85. Shiozawa P, 2014, INT J NEUROPSYCHOPH, V17, P1443, DOI 10.1017/S1461145714000418
  86. Smith R, 2013, J AFFECT DISORDERS, V146, P414, DOI 10.1016/j.jad.2012.07.029
  87. Stagg CJ, 2011, NEUROSCIENTIST, V17, P37, DOI 10.1177/1073858410386614
  88. Turner EH, 2008, NEW ENGL J MED, V358, P252, DOI 10.1056/NEJMsa065779
  89. Valiengo LCL, 2013, BRAZ J MED BIOL RES, V46, P815, DOI 10.1590/1414-431X20133115
  90. Van Oekelen D, 2003, LIFE SCI, V72, P2429, DOI 10.1016/S0024-3205(03)00141-3
  91. VENTIMIGLIA R, 1995, EUR J NEUROSCI, V7, P213, DOI 10.1111/j.1460-9568.1995.tb01057.x
  92. Vigod S, 2014, TRIALS, V15, DOI 10.1186/1745-6215-15-366
  93. Wang L, 2012, J AFFECT DISORDERS, V142, P6, DOI 10.1016/j.jad.2012.04.013
  94. Wolkenstein L, 2013, BIOL PSYCHIAT, V73, P646, DOI 10.1016/j.biopsych.2012.10.010
  95. Zanao TA, 2014, NEUROMODULATION, V17, P737, DOI 10.1111/ner.12167
  96. Zanardi R, 2007, EUR NEUROPSYCHOPHARM, V17, P651, DOI 10.1016/j.euroneuro.2007.03.008

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Artigos e Materiais de Revistas Científicas - FM/MPS
Artigos e Materiais de Revistas Científicas - FM/MCM
Artigos e Materiais de Revistas Científicas - HC/IPq
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Artigos e Materiais de Revistas Científicas - LIM/21
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