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ASSERT trial - How to assess the safety and efficacy of a high frequency rTMS in postpartum depression ? A multicenter, double blinded, randomized, placebo-controlled clinical trial.
Andriotti, Tomas; Stavale, Rafaelly; Nafee, Tarek; Fakhry, Stephanie; Mohamed, Mahmoud M A; Sofiyeva, Nigar; Ganho-Ávila, Ana; Bogner, Andreas; Barbosa, Sara P; Piton, Luciana S; Hirayama, André Luís S; Gaccia, Gisele; Smith-Howard Junior, Tomas P; Miranda, Priscila C; Reyes, Karen J Campoverde; Gragera, Alvaro; Nishiwaki, Hiroki; Boechat-Barros, Raphael.
Afiliação
  • Andriotti T; Sao Camilo Hospital, Rua Dr. Plinio Barreto, 173, 174B, São Paulo, SP, 01313020, Brazil.
  • Stavale R; University of Brasilia, School of Health Sciences, Department of Nursing, Campus Universitario Darcy Ribeiro, Brasilia, DF, 70910-900, Brazil.
  • Nafee T; Beth Israel Deaconess Medical Center, Department of Cardiology, Perfuse Study Group, 330 Brookline Ave, Boston, MA, 02215, United States.
  • Fakhry S; Iberoamerican University, School of Medicine, Av. Francia No. 129, Santo Domingo, DN, 10204, Dominican Republic.
  • Mohamed MMA; Umm Al-Quara University, Department of Clinical Pharmacy, Al Taif Road, Makkah, 24382, Saudi Arabia.
  • Sofiyeva N; Istanbul University, Cerrahpasa Medical Faculty, Department of Obstetrics and Gynecology, Cerrahpasa cad., Kocamustafapasa Mah., Faith, 34098, Istanbul, Turkey.
  • Ganho-Ávila A; Yale University, School of Medicine, Department of Obstetrics and Gynecology, New Haven, 06510, Connecticut, USA.
  • Bogner A; Proaction Laboratory, Univeristy of Coimbra, Faculty of Psychology and Educational Sciences, Rua do Colegio Novo, 6153, 3001-802, Coimbra, Portugal.
  • Barbosa SP; Neuropsychophysiology Laboratory, University of Minho, Research Center in Psychology, Campus de Gualtar, 4710-057, Braga, Portugal.
  • Piton LS; Clinica of Visceral, Thoracic and Vascular Surgery, Technical University of Dresden, 01069, Dresden, Germany.
  • Hirayama ALS; University of São Paulo at Ribeirão Preto, College of Nursing, Av. dos Bandeirantes, 3900 Campus Universitário Ribeirão Preto, SP, 14040-902, Brazil.
  • Gaccia G; Faculty of Medicine of ABC, Av. Príncipe de Galés, 821 - Vila Principe de Gales, Santo André, SP, 09060-650, Brazil.
  • Smith-Howard Junior TP; Hospital das Clinicas, Universidade de São Pualo, USP, SP, Brazil.
  • Miranda PC; Univeristy of Mogi of Crosses, Av. Imperatriz Leopoldina, 550 - Vila Leopoldina, São Paulo, SP, 05305-000, Brazil.
  • Reyes KJC; Metropolitan University of Santos, Campus Bandeirante I, Rua da Constituição no. 374, Vila Nova, Santos, SP, 11015-470, Brazil.
  • Gragera A; University of Brasilia, Campus Universitario Darcy Ribeiro, Brasilia, DF, 70910-900, Brazil.
  • Nishiwaki H; Massachusetts General Hospital, Harvard Medical School, 25 Shattuck Street, Boston, MA, 02115, United States.
  • Boechat-Barros R; University of Huelva Hospital Complex, Clinical Analysis Service, Ronda Exterior Nte, s/n, 21005, Huelva, Spain.
Contemp Clin Trials Commun ; 5: 86-91, 2017 Mar.
Article em En | MEDLINE | ID: mdl-29740625
BACKGROUND: Postpartum Depression affects a considerable number of women worldwide. This condition inflicts severe consequences to mother and child health. Thus far, available treatments have low response and high relapse rates. We designed this trial to evaluate a safe and more efficacious innovative therapy. AIMS: To report a feasible and ethical study design to assess the safety and efficacy of a high frequency repetitive Transcranial Magnetic Stimulation 10 Hz (rTMS) compared to sham rTMS in women with moderate to severe Post-Partum Depression using standard treatment (sertraline).To conduct an ancillary, exploratory, randomized, active controlled, double blind study with a hypothesis to assess the safety and efficacy of 10 Hz rTMS compared to sertraline. METHODS: A multicenter, parallel arm, randomized, placebo-controlled, double-blind design to assess safety and efficacy of 10 Hz rTMS compared to sham.An ancillary study will be conducted with parallel arm, randomized, active controlled and double dummy design to assess safety and efficacy of 10 Hz rTMS compared to sertraline.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Tipo de estudo: Clinical_trials Aspecto: Ethics Idioma: En Revista: Contemp Clin Trials Commun Ano de publicação: 2017 Tipo de documento: Article País de afiliação: Brasil País de publicação: Holanda
Texto completo
Adicionar na Minha BVS
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Tipo de estudo: Clinical_trials Aspecto: Ethics Idioma: En Revista: Contemp Clin Trials Commun Ano de publicação: 2017 Tipo de documento: Article País de afiliação: Brasil País de publicação: Holanda