2021/12/15 by Luca Sforzini, Courtney Worrell, Melisa Kose +58 · 1 voice · 1 citation
Medicine · Social Sciences · #Delphi Technique in Research #Maternal Mental Health During Pregnancy and Postpartum #Treatment of Major Depression
paper · pdf · doi:10.1038/s41380-021-01381-x
openalex publication_date 2021/12/15 · openalex created_date 2025/10/10 · openalex updated_date 2026/08/04
Criteria for treatment-resistant depression (TRD) and partially responsive depression (PRD) as subtypes of major depressive disorder (MDD) are not unequivocally defined. In the present document we used a Delphi-method-based consensus approach to define TRD and PRD and to serve as operational criteria for future clinical studies, especially if conducted for regulatory purposes. We reviewed the literature and brought together a group of international experts (including clinicians, academics, researchers, employees of pharmaceutical companies, regulatory bodies representatives, and one person with lived experience) to evaluate the state-of-the-art and main controversies regarding the current classification. We then provided recommendations on how to design clinical trials, and on how to guide research in unmet needs and knowledge gaps. This report will feed into one of the main objectives of the EUropean Patient-cEntric clinicAl tRial pLatforms, Innovative Medicines Initiative (EU-PEARL, IMI) MDD project, to design a protocol for platform trials of new medications for TRD/PRD.