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; Sofiyeva, Nıgar; Ganho-Avila, Ana; Bogner, Andreas; Barbosa, Sara; Piton, Luciana; Hirayama, Andre; Gaccia, Gisele; Smith-Howard Junior, Tomas; Miranda, Priscila; Reyes, Karen; Gragera, Alvaro; Nishiwaki, Hiroki; Boechat-Barros, Raphael

doi:10.1016/j.conctc.2017.01.004

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 T., Stavale R., Nafee T., Fakhry S., Mohamed M. M. A., Sofiyeva N., ...More

CONTEMPORARY CLINICAL TRIALS COMMUNICATIONS, vol.5, pp.86-91, 2017 (ESCI, Scopus)

Publication Type: Article / Article
Volume: 5
Publication Date: 2017
Doi Number: 10.1016/j.conctc.2017.01.004
Journal Name: CONTEMPORARY CLINICAL TRIALS COMMUNICATIONS
Journal Indexes: Emerging Sources Citation Index (ESCI), Scopus
Page Numbers: pp.86-91
Istanbul University Affiliated: Yes

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.