Psilocybin shows promise for treatment-resistant depression (TRD), but long-term data are limited. This study examined the antidepressant effect of one or two psilocybin doses with adjunct psychotherapy in TRD until twelve months. This is a naturalistic follow-up of a phase 2b, randomized, active placebo-controlled trial, where participants were randomized to receive two drug administrations...
Importance: Psilocybin shows promise in treating depression, although limitations of previous research warrant further research. Objective: To investigate the efficacy and safety of oral psilocybin, 25 mg, with adjunct psychotherapy in treatment-resistant depression (TRD). Design, Setting, and Participants: This was a 2-center, triple-blinded (investigator, participant, rater), phase 2b, active...
The integration of psychedelic therapies into European healthcare is a nuanced process that involves not only obtaining European Medicines Agency (EMA) approval but also successfully navigating Health Technology Assessment (HTA) evaluations across member states. After EMA approval, which focuses on the safety, efficacy, and quality of the therapeutic, HTA agencies assess these therapies for...
Psychedelic therapy is commonly understood as a form of psychotherapy. However, despite promising results from clinical trials, scientific progress has been hindered by a lack of theoretical integration between the fields of psychedelic and psychotherapy research. This article seeks to bridge this divide by outlining a transtheoretical understanding of psychedelic-occasioned psychological...
Novel antidepressive substances are challenging the explanations for the mechanisms of action of traditional psychopharmacology. What could be the shared effects of various antidepressants and in this context what role do extrapharmacological factors, such as the body and environment, play? The available literature on clinical and preclinical data for assumed combined active factors of...
Introduction: Serotonergic psychedelics, serotonin 2A receptor agonists such as psilocybin that can result in substantially altered states of consciousness, are used in recreational and research settings. The safety of psychedelic experiences in research settings is supported by controlled physical environments, presence of clinical and medical staff to address emergent issues, screening for...
Treatment with psilocybin differs fundamentally from classic psychopharmacotherapy. Its potentially transdiagnostic, rapid, and sustainable efficacy and its positive effect on further dimensions of mental health beyond the patient's symptoms and psychopathology imply that it may have diseasemodifying and salutogenic mechanisms of action. Psychotherapy accompanied by the administration of...
Background: Therapeutic and salutogenic effects of psychedelic drugs have been attributed to psychotherapeutic or psychotherapy-like processes that can unfold during the acute psychedelic experience and beyond. Currently, there are no psychometric instruments available to comprehensively assess psychotherapeutic processes (as conceptualized by empirical psychotherapy research) in the context of...
ZUSAMMENFASSUNG Gegenstand und Ziel Der vorliegende Artikel beschäftigt sich mit der Behandlung von psychischen Erkrankungen mit psychedelischen Substanzen aus einem psychotherapeutischen Blickwinkel. Dabei wird die Rolle der „Integration“ von psychedelischen Erfahrungen diskutiert. Es wird der Frage nachgegangen, wie die außergewöhnlichen Erfahrungen, die Menschen unter Psychedelikaeinfluss...
Treatment of psychiatric disorders with psychedelic substances represents one of the most promising current treatment approaches in psychiatry. Since its inception in the 1950s, therapy with psychedelics has been conceptualised as psychedelic-assisted psychotherapy-ie, a form of psychotherapy that uses the profound biological effects of this class of substances as a catalyst for changing...
Zusammenfassung In den letzten Jahren erlebte die klinische Forschung zur therapeutischen Wirksamkeit von Psychedelika eine Art Renaissance. Der aktuelle Stand wissenschaftlicher Erkenntnisse zur Wirksamkeit bei verschiedenen psychiatrischen Indikationen, wie auch die bereits unter bestimmten Voraussetzungen genehmigungsfähige Anwendung einiger psychedelischer Substanzen in der klinischen...
Abstract Rationale A general feeling of disconnection has been associated with mental and emotional suffering. Improvements to a sense of connectedness to self, others and the wider world have been reported by participants in clinical trials of psychedelic therapy. Such accounts have led us to a definition of the psychological construct of ‘connectedness’ as ‘a state of feeling connected to...
Background: Many benefits and some harms associated with psychedelic use could be attributable to these drugs’ acceptance/avoidance-promoting effects and corresponding changes in psychological flexibility. Underlying psychological mechanisms are insufficiently understood. Aim: The purpose of this study was the validation of a psychological model of acceptance/avoidance-promoting psychedelic...
Psychedelics, such as psilocybin represent one of the most promising current therapeutic approaches in psychiatry. Psychedelics seem to have not only potent antidepressant effects. Do they also work particularly quickly, i.e. within one day? The available literature on clinical studies of psychedelics in depressive syndromes is presented both from the period up to the prohibition of these...
Introduction: As their name suggests, 'psychedelic' (mind-revealing) compounds are thought to catalyse processes of psychological insight; however, few satisfactory scales exist to sample this. This study sought to develop a new scale to measure psychological insight after a psychedelic experience: the Psychological Insight Scale (PIS). Methods: The PIS is a six- to seven-item questionnaire...
Psychedelics such as psilocybin have recently gained remarkable interest in both the specialist literature and the lay press because studies suggest that these substances may have great therapeutic potential in various psychiatric disorders, including major depression. However, clinical trials with psychedelic drugs pose particular methodological challenges to researchers, some of which differ...
Abstract Classical psychedelics, primarily psilocybin and lysergic acid diethylamide (LSD), have been used and extensively studied in Western medicine as part of substance-assisted psychotherapy in the 1950s and 1960s. Modern clinical research is currently gaining momentum and provides new evidence for the safety and efficacy of classical psychedelics (primarily psilocybin, but also LSD and...
Psychedelic therapy shows promise as a novel intervention for a wide range of mental health concerns but its therapeutic action is incompletely understood. In line with acceptance and commitment therapy's (ACT's) transdiagnostic model, qualitative research has suggested that reductions in experiential avoidance are an important component of therapeutic outcomes associated with psychedelics....
For most psychiatric disorders, including alcohol use disorder (AUD), approved pharmacological treatments are limited in their effectiveness, and new drugs that can easily be translated into the clinic are needed. Currently, great hope lies in the potential of psychedelics to effectively treat AUD. The primary hypothesis is that a single session of psychedelic-guided psychotherapy can restore...
The efficacy of psychedelic-assisted therapies for mental disorders has been attributed to the lasting change from experiential avoidance to acceptance that these treatments appear to facilitate. This article presents a conceptual model that specifies potential psychological mechanisms underlying such change, and that shows substantial parallels between psychedelic therapy and cognitive...
Background: Psilocybin has shown promise as a treatment for depression but its therapeutic mechanisms are not properly understood. In contrast to the presumed actions of antidepressants, we recently found increased amygdala responsiveness to fearful faces one day after open-label treatment with psilocybin (25 mg) in 19 patients with treatment-resistant depression, which correlated with...