Introduction: Psychedelics, such as psilocybin, are increasingly recognized for their propensity to elicit powerful subjective experiences that carry personal meaning. While research has demonstrated the capacity for these compounds to promote psychological wellbeing, it has yet to be shown to what extent they modulate "meaning in life", a specific contribut...
The goal of this clinical trial is to test the feasibility of combining meditation with psilocybin microdosing in healthy adults. The main questions it aims to answer are: 1. Recruitment and retention feasibility 2. Acceptability, Safety and Tolerability 3. Exploratory Measures: 3.1: Explore potential changes in sleep quality and duration, heart rate variabi...
Psilocybin (PSIL) is a psychedelic drug and a promising experimental therapeutic for many psychiatric conditions. Precision functional mapping (PFM) combines densely repeated resting state fMRI sampling and individual-specific network mapping to improve signal-to-noise ratio (SNR) and effect size in brain imaging research. We present a randomized cross-over ...
This Phase 2a clinical trial is designed to evaluate the safety, tolerability, and preliminary efficacy of a 3 mg dose of psilocybin oral solution for the treatment of Generalized Anxiety Disorder (GAD). The study consists of three sequential phases: Screening Phase (up to 4 weeks), Open-label Run-in Phase (4 weeks), Double-blind Treatment Phase (4 weeks) Sc...
This thesis explores the psychosocial mechanisms underlying therapeutic responses to psychedelic interventions, advancing an enactive biopsychosocial perspective that foregrounds dynamic and reciprocal causal relationships between biological, psychological, and social processes. While clinical studies increasingly demonstrate the efficacy of serotonergic psy...
We present divergent experiences of 2 patients who participated in a clinical trial of psilocybin-assisted cognitive behavioral therapy for major depressive disorder. Both patients participated in an open trial involving 2 drug administration sessions separated by one month (10 and 25 mg, respectively) along with 12 sessions of cognitive behavioral therapy...
Psilocybin therapy (PT) is emerging as an effective intervention for Major Depressive Disorder (MDD), offering comparable efficacy to conventional treatments like selective serotonin reuptake inhibitors (SSRIs). Music, an emotionally evocative stimulus, provides a valuable tool to explore changes in hedonic and predictive processing mechanisms via expectancy...
Objective To evaluate psilocybin's efficacy in reducing depressive and anxiety symptoms in cancer patients based on randomized controlled trials (RCTs). Methods This systematic review and network meta-analysis (NMA) followed PRISMA and Cochrane Handbook guidelines. PubMed, Embase and Cochrane Library data up to July 2024 were analyzed. Two RCTs met the inclu...
Psilocybin is an active alkaloid found in magic mushrooms (Psilocybe cubensis). It is classified as a Class I Psychoactive Substance due to its psychoactive properties. Recent research has suggested that psilocybin holds potential for treating major depressive disorder. The objective of this study was to develop a physiologically based pharmacokinetic (PBPK)...
Regulatory compliance is crucial in the clinical development of psychedelic substances, including psilocybin. This study aimed to examine the alignment of clinical trial protocols for psilocybin in the treatment of major depressive disorder (MDD) and treatment-resistant depression (TRD) with established regulatory requirements.A cross-sectional investigation...
This is a single-arm, open-label interventional study of psilocybin-assisted interpersonal therapy for treatment resistant depression. 20 participants will be recruited to take part in this 8-week intervention that involves 8 sessions of psychotherapy and 2 doses of psilocybin. Study Design Interventional, Single arm, open label 1\. Hypotheses: 1. It is feas...
Mood dysfunction is highly prevalent in Parkinson's disease (PD), a main predictor of functional decline, and difficult to treat-novel interventions are critically needed. Psilocybin shows early promise for treating depression and anxiety, but its potential in PD is unknown, as safety concerns have excluded people with neurodegenerative disease from previous...
To examine the relationship of acute psychedelic effects and measures of mental health with headache frequency in clinical trials of psilocybin in migraine and cluster headache.
Introduction Selective reporting of outcome data (SOR) refers to trialists selecting results for publication based on the results of a subset of the initially measured outcomes. SOR for specific, potentially very profitable, treatments, particularly in key junctures such as in the period leading to or immediately preceding approval, has not been examined. Ob...
INTRODUCTION: Prolonged grief disorder (PGD) represents a substantial public health issue, especially in oncology settings where it affects up to 30% of bereaved carers. Current best-practice treatments are lengthy, and up to 50% of participants have persistent PGD. Building on encouraging recent research with psychedelic-assisted therapies, the Psilocybin-A...
