The application for MDMA-assisted therapy (MDMA-AT) and its rejection by the FDA in 2024 prompted a debate about ethical aspects in drug regulation. This paper examines central issues raised in that debate through the lens of human rights, especially the right to health. It argues that drug approval decisions must take into account the multipolar constellation of and dependencies between...
Treatment-resistant depression (TRD) remains a major clinical challenge in psychiatric practice and affects a substantial proportion of patients with major depressive disorder (MDD). It is commonly defined as failure to achieve remission after at least two adequately conducted antidepressant trials. TRD is associated with persistent functional impairment, increased morbidity, reduced quality of...
Increasing interest in psychedelic and related drugs as potential therapies for a wide spectrum of difficult to treat conditions that extend beyond neuropsychiatric disorders provided the impetus for this Themed Issue. This collection of reviews and original articles includes the mechanistic basis of how these drugs act, the current status of preclinical research and progress in clinical...
Psycholytic therapy, utilizing psychoactive compounds such as d-lysergic acid diethylamide (LSD) to enhance psychoanalytically oriented therapy, was once the most common form of psychedelic-assisted psychotherapy. Despite its historical prominence, little attention has been given to the reasons behind its decline, and there is a lack of standardized guidance for new clinical trials. This review...
Major Depressive Disorder (MDD) and chronic pain are independently debilitating conditions that frequently co-occur. This comorbidity poses a significant clinical challenge, resulting in greater symptom severity, higher disability, and worse prognosis than either condition alone. Current therapies often address each disorder in isolation, leaving individuals with comorbid MDD and chronic pain...
This piece is a personal and evidence-informed perspective on the current status and future direction of addiction psychiatry in the UK, based on my 30 years as a clinical academic addiction psychiatrist. Alcohol and drug addictions are associated with immense burdens to the individual and society, and this is likely to endure. Challenges facing addiction services to overcome include...
Mystical dynamics—the notion that mystical oneness may unfold involving ego disintegration, renewal, and luminous light—has been discussed anecdotally by psychedelic researchers and therapists but has not yet been empirically examined in controlled settings. This study investigated the occurrence and dose-dependency of mystical dynamics in healthy participants after administration of...
medRxiv Preprint ServerMarch 31, 2026Maia Mallevays, Louise Fuet, Michel Danon et al.1 citation
preprint
Esketamine is a fast-acting antidepressant drug which induces acute psychoactive effects. The most frequent is a dissociative state which seems unrelated to therapeutic efficacy. Other esketamine-induced effects, including psychedelic-like mystical experiences, have been poorly studied in terms of phenomenology and frequency, and may carry specific therapeutic relevance. In this study, we...
Abstract Alcohol use disorder is a major global health problem, and current treatments often fail to produce lasting reductions in harmful drinking1,2. Psychedelic-assisted therapies may promote durable behavioural change by enhancing brain plasticity during emotionally meaningful experiences, but progress has been limited by a lack of experimental models that capture these context-dependent...
Psilocybin-assisted therapy has emerged as a promising intervention for treatment-resistant depression (TRD), yet standardized and transparent therapeutic frameworks remain limited. This therapist manual was developed for the EPIsoDE trial, a phase IIb randomized clinical study investigating the efficacy and safety of psilocybin with adjunct psychotherapy in patients with TRD (NCT04670081). The...