Neuroscience Applied
January 1, 2022
Lea J. Mertens, Michael Koslowski, Felix Betzler et al.
40 citations
Clinical trials with psychedelics like psilocybin face unique methodological challenges, particularly the difficulty of maintaining blinding due to the substances' pronounced subjective effects, which raises risks of expectation bias and nocebo effects. A phase II randomized, double-blind, active placebo-controlled parallel group trial with 144 patients is underway to evaluate psilocybin's efficacy and safety in treatment-resistant major depression. The trial, called EPIsoDE, is funded by the German Federal Ministry of Education and Research and addresses these challenges in its design.
General hospital psychiatry
January 1, 2025
Max Wolff, Hans Rutrecht, Gerhard Gründer et al.
9 citations
As psychedelic treatments move from research settings into hospitals, clinics, and community practices, a new competencies framework outlines the skills needed for safe, effective, and ethically sound therapy. The framework is substance-unspecific and transtheoretical, covering foundational domains including psychotherapy, biomedicine, philosophy, socio-cultural awareness, existential concerns, legal issues, and self-experience. It translates these into practical competencies for multi-professional cooperation, screening, preparation, dosing, integration, and harm-reduction. Developed within the MIND Foundation's Augmented Psychotherapy Training program, the framework awaits systematic evaluation but offers an initial blueprint for future accredited certification and clinician training as these treatments enter mainstream care.
Deutsches Ärzteblatt international
December 16, 2024
Moritz Spangemacher, Andrea Jungaberle, Henrik Jungaberle et al.
3 citations
Psilocybin treatment works differently from standard psychiatric medication, potentially offering rapid and lasting benefits across multiple diagnoses. It may improve not just symptoms but broader aspects of mental health, suggesting it could modify the underlying disease process and promote well-being. Psychedelic-assisted psychotherapy might become the first disease-modifying treatment in psychiatry.
Psychotherapy and psychosomatics
May 27, 2026
Lea J Mertens, Felix Betzler, Manuela Brand et al.
A single 25 mg dose of psilocybin, or two such doses given six weeks apart, combined with psychotherapy produced a stable and clinically meaningful reduction in depression symptoms for up to twelve months in people with treatment-resistant depression. The average improvement on the Hamilton Rating Scale for Depression was about 7.9 points at six months and 7.7 points at twelve months, with no significant difference between dosing groups. Restarting standard antidepressant medication during follow-up was strongly linked to higher depression scores. This naturalistic follow-up of a phase 2b trial is the largest and most complete long-term assessment of psilocybin for depression to date.