The Lancet Psychiatry
December 12, 2023
Gerhard Gründer, Manuela Brand, Lea J. Mertens et al.
103 citations
Treatment of psychiatric disorders with psychedelic substances is promising, but there is debate over whether therapeutic effects come solely from the drug or require psychotherapy. Some recent studies suggest the substance alone may be responsible, with therapists providing only safety support. This Personal View argues that viewing psychedelic treatment as a purely biological intervention with psychological support for safety reflects an outdated, reductionistic dualism that has long dominated psychiatry. The discussion has important implications for how these compounds are studied and regulated.
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.
Current topics in behavioral neurosciences
November 22, 2025
Helena D Aicher, Anke Röskamp, Marianne Moser et al.
4 citations
Touch has long been central to human communication and healing, but in psychedelic-assisted therapy it raises complex ethical and practical challenges due to patients' heightened vulnerability. Recent reports of boundary violations have sharpened the debate. From a harm reduction perspective, the chapter acknowledges risks and the need for clear boundaries, transparency, informed consent, and cultural sensitivity, while arguing that touch can offer grounding, emotional support, and therapeutic value when used responsibly. Both touch and non-touch interventions are explored, including historical roots and therapeutic potentials, with ethical frameworks outlined to support safe, ethical, and effective practices.
Nervenheilkunde
April 1, 2024
Manuela Brand, Luca V. Faerber, Laura Kaertner et al.
1 citation
This article examines the treatment of mental illnesses with psychedelic substances from a psychotherapeutic perspective, focusing on the role of integrating psychedelic experiences. It asks how extraordinary experiences under the influence of psychedelics can be harnessed for psychotherapeutic progress. After an introductory overview of phases of psychedelic-assisted therapy (PAT), it describes a possibility for psychotherapeutically guided integration of psychedelic experiences using the example of treating treatment-resistant depressed patients with psilocybin in a clinical trial (EudraCT: 2019–003984–24; NCT04670081). The integration of psychedelic experiences into daily life is a scientifically little-studied but essential part of PAT. Evidence-based protocols should be developed to increase the efficacy and safety of therapy through integration methods. With the introduction of PAT into established healthcare systems, integration of psychedelic experiences is expected to become increasingly important.
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.
Der Nervenarzt
March 1, 2022
Gerhard Gründer, Manuela Brand, Laura Kärtner et al.
Psychedelics like psilocybin are among the most promising new treatments for depression, potentially working within one day. A review of clinical studies from before the 1960s prohibition and after the 2000s revival—mostly using psilocybin—shows small sample sizes (total depressed patients <200) and some methodological weaknesses. Nevertheless, the evidence suggests a pronounced, very rapid antidepressant effect within one day for depression, treatment-resistant depression, and depression in life-threatening cancer, often lasting several months. Ongoing studies with hundreds of patients will clarify psilocybin's potential.