Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
5549651 | Contemporary Clinical Trials Communications | 2017 | 6 Pages |
BackgroundPostpartum 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.AimsTo report a feasible and ethical study design to assess the safety and efficacy of a high frequency repetitive Transcranial Magnetic Stimulation 10Â 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 10Â Hz rTMS compared to sertraline.MethodsA multicenter, parallel arm, randomized, placebo-controlled, double-blind design to assess safety and efficacy of 10Â 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 10Â Hz rTMS compared to sertraline.