This commentary (2023) showcases the support, and open questions, from the European regulatory perspective. It highlights the difficulties facing psychedelic trials (e.g. blinding), and showcases the support EMA can offer in ensuring the trials get done in a way that will lead to regulatory approval.
More than one in six people in the European Union have mental health problems, significantly impacting individuals and society. Finding safe and effective new treatments for mental disorders is essential. Recently, there has been growing interest in using psychedelic drugs to treat mental health conditions, like depression and post-traumatic stress disorder. These drugs can change a person’s consciousness and create different feelings, like feeling at one with the universe, but they can also cause anxiety and distress. Classic psychedelics work similarly to each other, while atypical psychedelics have different effects and legal statuses. This article is based on the work of experts who advise the European Medicines Agency (EMA) and the European College of Neuropsychopharmacology (ECNP) on these issues.
Authors: Florence Butlen-Ducuing, Drummond E-Wen McCulloch, Marion Haberkamp, Taina Mattila, Ewa Bałkowiec-Iskra, Georgios Aislaitner, Pavel Balabanov, Johan Lundberg, Dea Siggaard Stenbæk, Andre Elferink, Gitte M. Knudsen & Steffen Thirstrup
Summary of The therapeutic potential of psychedelics
There is a need for effective, safe new treatments for mental disorders in the EU. Psychedelic substances induce alterations of consciousness, but can also induce anxiety and psychological distress, which can be alleviated through interpersonal support during administration.
More research is needed to determine the therapeutic potential of psychedelics for mental disorders. Double blinding is challenging, and other study design strategies should be considered, such as low-dose comparators or an active placebo.