Phase 3 Trial with Psilocybin‐assisted Therapy for Depression ‐ European Consortium
- 2:45 - 3:15
- Track 3: Albrecht Kossel room (Charité)
Psilocybin‐assisted therapy shows clear potential for depression and other indications in recent clinical trials. While there are two FDA Breakthrough designation programmes with psilocybin for depression in the US ﴾Usona Institute and CompassPathways﴿, there is less focus on Europe. The importance of a European consortium not controlled by venture capital, taking on phase 3 clinical trials, and registration of psilocybin‐assisted therapy for Major Depressive Disorder is discussed. An effort controlled by foundations, combining insights on the potential of psychedelic‐assisted therapy with statutes regulating that revenues should go to research on psychedelics, could play an important role when the first psychedelics are introduced to the pharmaceutical market in Europe.
There is an opportunity to form a European consortium of clinical psychedelic research groups, public healthcare representatives, insurance companies, psychedelic clinics, therapist training institutes, and patient organizations. With a strong consortium and project plan, significant funding for clinical development are also possible from the European Commission in Horizon Europe calls. Bringing psilocybin‐assisted therapy to the market as a purely non‐profit, exclusively funded by the European Commission and donations, is expected to be challenging.
A hybrid model based on purpose economy/steward ownership ﴾e.g. Zeiss, Bosch﴿, is proposed. Investors would enable clinical development, registration, and pharmaceutical market presence with funding while taking part of potential revenues in the future. Foundations would have control through super‐voting shares, to ensure that the project focus on understanding the potential of psychedelic‐assisted therapy to meet society’s needs. Should the market be profitable, revenues are shared between investors and foundations. The community of psychedelic researchers has an opportunity to bring psychedelics to market in a collaborative and society‐focused way.
Medicalization of the first psychedelics will make psychedelic‐assisted therapy treatment available to many patients in need. This comes with great potential, but also significant risks, which public healthcare and society as a whole are largely unaware of at this time. Osmond Labs is an initiative to combine European expertise on psychedelic‐assisted therapy with enabling funding, in a construct built to focus on society needs.
The renaissance of psychedelic research has brought with it many opportunities for improving mental health. However, carrying out clinical studies and bringing psychedelic mental health care to pat
This presentation will go over the preliminary evidence for the efficacy and safety of psilocybin, a serotonergic psychedelic acting as a partial 5-HT2A agonist, in the treatment of treatment-resis