In 1970, Congress passed the Controlled Substances Act and swiftly placed psilocybin (the active chemical in “magic mushrooms”) under Schedule I-the strictest level of regulation withheld for substances with “no currently accepted medical use.” While the United States has maintained this rigid framework, Jamaica has taken the opposite approach. Psilocybin wa...
Background Classic serotonergic psychedelics such as LSD and psilocybin show promising antidepressant effects in controlled trials, but real-world data from routine clinical care remain limited. Methods This study retrospectively analysed routine data from adults with treatment-resistant depressive and/or anxiety disorders who received a first standardized P...
Background: Psilocybin-assisted psychotherapy (PAP) may be an effective intervention for a range of mental disorders. However, there appears to be a relative lack of qualitative evidence to complement emerging quantitative findings. To our knowledge, no reviews have systematically mapped the literature on qualitative studies on PAP for the treatment of menta...
BACKGROUND: Cognitive difficulties within treatment-resistant unipolar and bipolar depression (TRD; TRBD) often do not improve with conventional pharmacotherapies. Psilocybin-assisted psychotherapy (PAP) has shown promise as a novel intervention for TRD; however, few studies have assessed its effects on cognition in this population. METHODS: This retrospecti...
Highly stressful events can lead to post-traumatic stress disorder (PTSD)-a significant public health concern which existing treatments (e.g., psychotherapy and traditional medications) have shown marginal efficacy for.Psychedelics-alternatively called hallucinogens-are psychoactive substances that cause perception, mood, and cognitive changes.Because they a...
Serotonergic psychedelics and 3,4-methylendioxtmethamphetamine (MDMA) are promising treatments for mental disorders with a continuously evolving evidence base. We searched Pubmed/Scopus/clinical trial registries up to 08july2025 for double-blind randomized controlled trials (RCTs) testing MDMA or serotonergic psychedelics in patients with mental disorders. P...
Background/importanceChronic pain affects many people globally, requiring alternative management strategies. Psilocybin is gaining attention for its potential in chronic pain management despite being classified as Schedule I.ObjectiveThis systematic review critically evaluates the evidence for psilocybin, a Schedule I substance, in the treatment of chronic p...
BACKGROUND: Psilocybin-assisted psychotherapy (PAP) has gained attention as a promising intervention for conditions including depression, anxiety and post-traumatic stress disorder, but understanding of its side-effects is limited. This review evaluates the quality of side-effects reporting in PAP trials, to guide treatment, policy and research. AIMS: To ass...
IntroductionBipolar disorder (BD) is a severe and persistent mental disorder characterized by recurrent mood episodes, with BD depression accounting for most of the illness burden. Although the mainstay treatment of BD consists of pharmacotherapy with mood stabilizers and atypical antipsychotics, a large proportion of patients with BD depression do not respo...
Investigators will recruit 36 individuals on MAT for OUD for a double-blind, placebo-controlled design to determine whether PEX010 (25-mg/d) shows preliminary efficacy on neural correlates of neurocognition and on clinical outcomes. Participants will be randomized to either (single dose) 25-mg (PEX010-25 group) or 1-mg (PPEX010-1 group) PEX010 in a 2:1 ratio...
BackgroundResults from contemporary clinical trials of serotonergic psychedelic therapies have led to an increasing focus on their potential clinical use across mental disorders. However, studies examining mechanisms of clinical response to psychedelic therapy in psychiatric populations are limited. This review aimed to synthesize evidence from studies exami...
Recent antidepressant drug development focuses on a next generation of drugs to rapidly relieve symptoms. Yet, how ketamine, the prototype rapid-acting antidepressant, maintains symptom relief days after drug elimination, and how repeated doses sustain longer-lasting therapeutic effects, remains unclear. Derived from elements of metaplasticity (synaptic prim...
This retrospective observational study examines the effects of psychedelic-assisted psychotherapy (PAP) with lysergic acid diethylamide (LSD) or psilocybin in patients with treatment-resistant depressive, anxiety, or addictive disorders. Data will be analyzed from patients treated at the University Hospitals of Geneva between June 2020 and April 2025 who obt...
The goal of this clinical trial is to test psilocybin in combination with mindfulness training in healthy adults. The main question it aims to answer is "Does mindfulness training enhance the effects of psychedelic therapy (psilocybin) on mental health?" Interested individuals will complete an initial eligibility session and eligible participants will then b...
The purpose for this study is to observe the real world experience of participants who are receiving psilocybin in the context of (alcoholism) Alcohol Use Disorder without intervening in the model of care. The study team will engage directly with the participants to examine the outcomes in participants who have been deemed eligible and appropriate to receive...
BackgroundPsilocybin-Assisted Psychotherapy (PAP) has gained increasing attention in recent years as a potential treatment for depression, particularly in cases resistant to conventional therapies. This article aims to assess the efficacy of PAP in adults with various forms of depression by conducting a comprehensive review of the available literature.Method...
Supplement 1. Additional tables presenting primary and secondary outcomes, sensitivity analyses, and exploratory findings. Table A1. ITT analyses for QIDS-SR-16 and MBI-HSS-MP. Table A2. Adjusted ITT analyses for QIDS-SR-16 and MBI-HSS-MP. Table B1. Intent-To-Treat (ITT) Analysis for Demoralization Scale (DSII) and PTSD Checklist for DSM-5 (PCL-5). Table B2....
Rationale: Recent evidence shows that Lysergic Acid Diethylamide (LSD), even when administered in low, non-hallucinogenic doses, can produce analgesic effects and improve pain tolerance in a sample of healthy volunteers. Such results complement what was already observed with other serotonergic psychedelics such as psilocybin: survey studies and case series i...
BackgroundPsychedelics are emerging as promising treatments for major depressive disorder (MDD) and treatment-resistant depression (TRD). Functional magnetic resonance imaging (fMRI) offers a powerful tool to study neural mechanisms underlying therapeutic response.MethodsThis systematic review (PROSPERO #CRD42024557973) examined neuroimaging studies of psilo...
BackgroundSuicidal ideation, attempts, and deaths present a major and tragic public health concern. Recent trials of psilocybin therapy (PT) have shown promise in treating treatment-resistant depression and have found a reduction in suicidal ideation. Given the growth of PT research, there is a need to further understand its effect on suicidal ideation, atte...
