This systematic review and meta-analysis synthesized data from 13 clinical trials (n=606) evaluating psilocybin-assisted psychotherapy for major depressive disorder and treatment-resistant depression. Despite early enthusiasm, the pooled standardized mean difference (-0.79, 95% confidence interval: -3.98 to 2.40, p=0.63) revealed no statistically significant...
Psilocybin-assisted therapy shows promise for depression, though current evidence relies on Phase 2 trials with notable methodological limitations. We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) evaluating psilocybin-assisted therapy for major or treatment-resistant depression up to February 2024. We evaluated depre...
In the past year, the medical regulation of psilocybin-assisted therapy has expanded across additional international jurisdictions, requiring an update to the original medico-legal synthesis. Newly established or clarified regulatory pathways in New Zealand, Germany, Switzerland, the Czech Republic, and at the United States federal level reflect continued ev...
This article proposes a research agenda for psilocybin-assisted therapy focusing on the correlation between neural entropy and long-term cognitive flexibility.
Abstract Rationale Clinical interest in psilocybin-assisted rehabilitation for motor disorders is growing. However, psilocybin’s motor effects are under-researched, and quantifying them is essential for assessing treatment risks and outcomes. Objectives This study aims to clarify whether acute effects of psilocybin disrupts established patterns of manual dex...
Abstract Background and aims Psilocybin, a psychoactive compound found in fungi commonly referred to as “magic mushrooms,” is consumed for both spiritual and recreational purposes. However, psilocybin use in Puerto Rico remains understudied. This exploratory cross-sectional survey aimed to describe patterns of use, motivations for consumption, explanatory fa...
Altered states of consciousness (ASC) represent a universal human capacity for accessing and transforming the subconscious mind, employed across cultures and millennia through diverse contemplative, somatic, pharmacological, ritual, and technological modalities. This comprehensive review synthesizes evidence from over 25 distinct disciplines spanning five cl...
The goal of this clinical trial is to learn if a single dose of psilocybin (5mg Vs 10mg Vs 25mg) alongside psychotherapy is safe and can help treat treatment resistant depression (TRD) with co-occurring substance use disorder (SUD) in veterans and first responders. We seek to answer: * Whether 5mgs, 10mgs and 25mgs of psilocybin are safe in individuals with ...
This Phase 2a pilot, exploratory, randomized, double-blind, placebo-controlled, parallel-group trial will estimate whether concurrent fluoxetine alters the antidepressant effect, acute psychedelic experience, or safety of a psychedelic-assisted psychotherapy session in adults with treatment-resistant major depressive disorder (TRD). Eligible participants (ag...
Background: Psilocybin-assisted therapy (PAT) has shown promise for alcohol use disorder (AUD) in randomized controlled trials (RCTs). However, the effects of open-label administration following blinded treatment are unclear. Here, we present safety and efficacy data from an open-label extension of a Phase II RCT (NCT02061293) examining PAT for AUD. Methods:...
Background/Objectives: Psilocybin has re-emerged as a promising intervention for neuropsychiatric disorders including major depressive disorder, treatment-resistant depression, anxiety associated with life-threatening illness, obsessive compulsive disorder, and substance use disorders. However, conventional randomized controlled trials (RCTs)-the current gol...
Note: The trial is only eligible for citizens of Denmark. The purpose of this project is to assess the treatment efficacy of a single high dose of psilocybin administered within a protocol of psychological support to patients diagnosed with alcohol use disorder (AUD). To establish efficacy, we will investigate a single dose of psilocybin versus placebo in a ...
PRE-EMPT will assemble a study group of 150 civilian and Veteran participants from three populations (low risk, intermediate risk, and high risk for self-harm). The investigators will obtain clinical assessments, MRI, and blood levels for circular RNA (circRNA). The teams will then administer three interventions (neurofeedback, transcranial magnetic stimulat...
We propose a first-of-its-kind open-label clinical trial to investigate the feasibility, tolerability, and safety of administering psilocybin in autistic adults with treatment-resistant depression (TRD). In this study, 20 participants (intellectually able and fluent-speech adults) with autism and co-occurring TRD will receive around 20 hours of manualized ps...
ABSTRACT Accidental ingestion of psilocybin-containing mushrooms can cause poisoning and hallucinations, making their rapid detection a public health priority. Conventional methods such as HPLC, GC-MS, LC-MS, TLC, CE, and ELISA provide sensitivity but are often destructive, time-consuming, or impractical for real-time applications. This study introduces a Ra...
Depression and psychological distress are highly prevalent among patients with cancer and are associated with impaired quality of life, reduced treatment adherence, and poorer clinical outcomes. Standard pharmacological and psychosocial interventions often demonstrate limited efficacy or delayed onset of action in oncological and palliative settings. Psilocy...
Psilocybin-assisted therapies are innovative therapeutic approaches, particularly in the treatment of depression. However, there are sparse studies providing functional magnetic resonance imaging (fMRI) evidence elucidating the underlying biological mechanisms that support clinical outcomes. This review aims to comprehensively gather all the evidence reporte...
This pilot study will evaluate the therapeutic potential of psilocybin in people with Cannabis Use Disorder (CUD). This study will examine the impact of psilocybin treatment on cannabis use and related variables in 12 people with CUD. This is an open-label proof-of-concept trial in which participants will complete a 12-week course of study treatment includin...
