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. , ...Daha Fazla

CONTEMPORARY CLINICAL TRIALS COMMUNICATIONS, cilt.5, ss.86-91, 2017 (ESCI İndekslerine Giren Dergi) identifier identifier identifier

  • Cilt numarası: 5
  • Basım Tarihi: 2017
  • Doi Numarası: 10.1016/j.conctc.2017.01.004
  • Dergi Adı: CONTEMPORARY CLINICAL TRIALS COMMUNICATIONS
  • Sayfa Sayıları: ss.86-91

Özet

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.