Please use this identifier to cite or link to this item: http://cris.unibe.edu.do/handle/123456789/316
Title: 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
Autores: Andriotti, T.
Stavale, R.
Nafee, T.
Fakhry Tonos, Stephanie
Mohamed, M.
Sofiyeva, N.
Ganho- Avila, A.
Bogner, A.
Barbosa, S.
Piton, L.
Hirayama, A. L.
Gaccia, G.
Smith-Howard, T. P.
Miranda, P.
Campoverde Reyes, K.
Gragera, A.
Nishiwaki, H.
Boechat-Barros, R.
Researchers (UNIBE): Fakhry Tonos, Stephanie 
Affiliations: Facultad de Ciencias de la Salud 
Research area: Ciencias de la Salud
Keywords: Postpartum depression; Repetitive Transcranial Magnetic Stimulation; Research clinical trial
Issue Date: 2017
Publisher: Elsevier Inc.
Source: Contemporary Clinical Trials, 5, 86-91.
Journal: Contemporary Clinical Trials 
Volume: 5
Start page: 86
End page: 81
Abstract: 
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.
URI: http://cris.unibe.edu.do/handle/123456789/316
DOI: 10.1016/j.conctc.2017.01.004
Appears in Collections:Publicaciones de la Facultad de Ciencias de la Salud

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