BACKGROUND: Treatment-resistant depression (TRD) imposes a substantial public health and economic burden. Although psilocybin-assisted therapy (PAT) has shown clinical promise, its economic value remains uncertain. This study evaluated the cost-effectiveness of PAT compared with the standard of care for TRD. METHODS: A Markov model adopting a US healthcare p...
The goal of this pilot, exploratory, clinical trial is to investigate the effects of psilocybin on synaptic vesicular density (SVD) as measured by the positron emission tomography (PET) radiotracer, 18F-SynVesT-1, in participants with amnestic Mild Cognitive Impairment (aMCI) and healthy participants. The investigators hypothesize that SVD levels in the brai...
People with cancer often experience anxiety and depression following a diagnosis and can face barriers to accessing treatment for their mental health. An increasing number of patients are considering alternative approaches to managing their mental health symptoms, such as the psychedelic, psilocybin. A growing number of clinical trials show significant and e...
The goal of this clinical trial is to determine the safety and efficacy of psilocybin assisted Therapy (PAT) in individuals with comorbid Major Depressive Disorder (MDD) and Alcohol Use Disorder (AUD). The main question it aims to answer is: \- What is the feasibility and safety of administering PAT in adults with MDD-AUD by evaluating recruitment, retention...
Psychedelic- and substance-assisted therapies, including MDMA, psilocybin, and ketamine, are gaining attention for conditions such as PTSD and depression, yet their development and implementation remain largely concentrated in high-income settings. This graphical abstract summarizes the central argument of the commentary: while these interventions may hold r...
Microdosing - once a niche practice whispered about in online forums and tech circles - has firmly entered the mainstream. A new RAND survey suggests that millions of U.S. adults are now taking sub-perceptual amounts of psychedelics such as psilocybin, LSD and MDMA, often with goals that differ sharply from those associated with traditional, full-dose use.
This is a double-blind, adaptive, 2-stage, multi-site, phase 2 randomized controlled clinical trial designed to evaluate effects of moderate and high dose psilocybin, relative to low-dose psilocybin control, in OUD patients who continue to use illicit opioids in spite of adherence to standard-of-care treatment with methadone. Up to 480 participations will be...
The escalating global burden of mental health disorders, coupled with the stagnation of innovation in traditional monoaminergic pharmacotherapy (e.g., SSRIs), has precipitated a critical need for novel therapeutic paradigms. This article presents a comprehensive systematic review of the so-called "Psychedelic Renaissance," focusing on the clinical resurgence...
Psychedelics such as psilocybin, LSD, and MDMA have shown promise in treating mental health conditions (e.g., depression, post-traumatic stress disorder) among neurotypical individuals, i.e., typically developing individuals without a diagnosed neurodevelopmental condition. However, their therapeutic potential for treating co-occurring mental-health conditio...
This study aims to explore the safety and tolerability of a single dose of psilocybin (25mg) administered under supportive conditions to adult participants with TRD and chronic suicidal ideation
This Phase 2a clinical trial is an open-label, single-group, within-subjects pilot study designed to evaluate the safety, feasibility, and preliminary efficacy of psilocybin as a therapeutic intervention for adults with developmental stuttering. This pilot study will assess whether further research to explore the potential benefits of psilocybin-assisted the...
Dear Editor, In view of ongoing global research on mental health, especially Major Depressive Disorder, we would like to draw attention to a psychedelic substance, Psilocybin, which has been emerging as a viable treatment option for MDD. Psilocybin is a psychedelic compound derived from certain mushrooms that acts on Serotonergic receptors (primarily 5HT-2A)...
Australia's reclassification of psilocybin as a Schedule 8 substance for treatment-resistant depression represents a significant shift in psychiatric policy. While this regulatory change positions Australia as a global leader in psychedelic medicine, its implementation has revealed substantial challenges. This article critically examines the regulatory, ethi...
The global demographic shift toward aging populations has intensified the need for innovative therapeutic interventions targeting late-life mental health conditions, notably depression, loneliness, and existential distress. Traditional pharmacological treatments often exhibit limited efficacy and poor tolerability in older patients, primarily due to age-rela...
The purpose of this research is to study the safety and effects of single-dose psilocybin 25mg versus an active placebo (single dose niacin 100mg) in the treatment of anxiety, depression, and existential distress (i.e., loss of meaning and hope; fear of death) in advanced cancer (i.e., stage 3 or 4). Study medications will be administered in conjunction with...
Introduction Psychedelic Assisted Psychotherapy (PAP) has been legal in Switzerland since 2014 under supervised exceptional medical use with MDMA, LSD and Psilocybin with case by case authorisations delivered from the Federal Office of Public Health. In particular, since 2021, we have implemented a clinical activity at Geneva University Hospital (HUG) for tr...
Introduction Mental health disorders, including depression, anxiety, and post-traumatic stress disorder (PTSD), remain a significant global health concern, requiring novel therapeutic approaches. Psilocybin, a psychedelic compound found in certain mushrooms, has shown potential in modulating neuroplasticity, a critical process for cognitive flexibility and m...
Renewed interest in the therapeutic potential of psychedelics has led to increased research, but this work often lacks diverse representation. This study examined the relationships between subjective psychedelic experiences and self-reported improvements in symptoms of depression, anxiety, and substance use among Spanish-speaking individuals. A global sample...
Objective: To assess the safety and efficacy of a six-week microdosing regimen of psilocybin combined with short-term, experience-based psychotherapy in patients with treatment-resistant depression who have not responded to previous pharmacological or long-term psychological interventions. Hypothesis: Compared to baseline, the group that begins with psilocyb...
