Depressive disorders are highly prevalent and disabling medical conditions worldwide. Medicinal products with better efficacy, improved safety and more personalised profiles are much needed. Our colleagues André Elferink and Taina Mattila cooperated with other experts of the medicines authorities of Germany, Poland and France in the CNS working party drafting a new updated EMA guideline for drug researchers and developers working on antidepressants. The revised guideline on clinical investigation, to replace the previous guideline that came into force in 2013. The document is available for external consultation until March 31, 2024. The new draft is the third revision of the guideline, which incorporates the latest insights in requirements for clinical trials in this field. Updates have been made for example in requirements for clinical trials in difficult to treat patient populations (treatment resistant and partial responders), and for the first time, antidepressants with a rapid onset of effect, psychedelics and targeted therapies to address symptom clusters are addressed in the guideline. More details on the proposed changes in the guideline are summarized in an article https://lnkd.in/eZq5eAqG Please note that there is also a new draft Guideline on clinical investigation of medicinal products in the treatment of epileptic disorders up for consultation on the website of the European Medicines Agency: https://lnkd.in/esR7GQ2b
