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The new European Medicines Agency guideline on antidepressants: a guide for researchers and drug developers.

Authors :
Butlen-Ducuing, Florence
Haberkamp, Marion
Aislaitner, Georgios
Bałkowiec-Iskra, Ewa
Mattila, Taina
Doucet, Marika
Kollb-Sielecka, Marta
Balabanov, Pavel
Leuchs, Ann-Kristin
Elferink, André
Source :
European Psychiatry; 2024, Vol. 67 Issue 1, p1-3, 3p
Publication Year :
2024

Abstract

The European Medicines Agency (EMA) has released a new guideline on the clinical investigation of antidepressants. The guideline aims to improve the efficacy, safety, and personalization of these medications. It provides information on depressive disorders, clinical trial methodology, statistical analysis, and requirements for trials in difficult-to-treat populations. The guideline also discusses the use of psychedelics in depression treatment and highlights the need for randomized, double-blind, placebo-controlled trials. The ongoing consultation process will address remaining challenges in the field. [Extracted from the article]

Details

Language :
English
ISSN :
09249338
Volume :
67
Issue :
1
Database :
Complementary Index
Journal :
European Psychiatry
Publication Type :
Academic Journal
Accession number :
176400367
Full Text :
https://doi.org/10.1192/j.eurpsy.2023.2479