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.
Commun Psychol
April 13, 2025
Martha N. Havenith, Max Leidenberger, Jelena Brasanac et al.
14 citations
Altered states of consciousness (ASCs) similar to those induced by psychedelics can be achieved through circular breathwork, a non-pharmacological practice. During breathwork sessions, deliberate hyperventilation reduces end-tidal CO2 pressure, which is significantly correlated with the onset of ASCs. The depth of these ASCs predicted subsequent improvements in well-being and reductions in depressive symptoms. Two forms of breathwork, Holotropic and Conscious-Connected, produced highly similar outcomes. The findings identify physiological conditions for ASCs outside of drug use, suggesting breathwork's potential as an accessible psychotherapeutic tool.
JAMA Psychiatry
March 18, 2026
Lea J. Mertens, Michael Koslowski, Felix Betzler et al.
9 citations
A phase 2b randomized clinical trial tested 25 mg of psilocybin with psychotherapy against a 5 mg dose and a placebo (nicotinamide) in 144 adults aged 25 to 65 with treatment-resistant depression who had stopped antidepressants. The primary outcome—a 50% or greater reduction in depression scores at six weeks—was not statistically significant: 17.0% of those receiving 25 mg responded, versus 12.5% on 5 mg and 10.6% on placebo. Exploratory analyses suggested a clinically meaningful reduction in depressive symptoms with the 25 mg dose. The treatment was generally well tolerated, but safety signals included higher reports of suicidal ideation on dosing days and two serious adverse reactions, one case of hallucinogen persisting perception disorder.
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.
Research Square
February 22, 2024
Martha Havenith, Max Leidenberger, Jelena Brasanac et al.
3 citations
Circular breathwork, which involves deliberate hyperventilation, can induce altered states of consciousness (ASCs) comparable to those produced by psychedelics, without the legal, medical, or financial barriers. A reduction in end-tidal CO2 pressure due to hyperventilation is instrumental in catalyzing these ASCs. The depth of the ASCs predicted psychological and physiological follow-on effects, including improved well-being and a reduction of depressive symptoms. Two popular forms of breathwork—Holotropic Breathwork® and Consciously-Connected breathwork—produced highly similar physiological, experiential, and psychological outcomes. These findings outline physiological boundary conditions for ASCs in a non-pharmacological context and suggest breathwork's potential as an accessible psychotherapeutic tool.
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.