The goal of this neuroimaging clinical trial is to test whether psilocybin produces significant immediate changes in functional brain activity in networks associated with mood regulation and depression compared to placebo in patients with depression. The trial aims to determine if psilocybin: 1. Changes connectivity within brain networks associated with mood...
Psychedelics are increasingly described as a new therapeutic approach in a variety of mental disorders including depression. Oral psychedelics such as psilocybin have an acute effect evolving over 6-8 h and are generally given in combination with psychological support. There is debate on the exact role of this support and how and by whom it should be deliver...
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...
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...
Can a guided psychedelic experience with psilocybin successfully treat refractory depression? In other words, setting aside any simple direct biological drug effect, can psychedelic-assisted psychotherapy1 alleviate suffering via what William James would call a mystical experience?2
In April 2024, FSQ Forensic Chemists attended Queensland’s largest mushroom growing operation. Seized items included: 219 50 L plastic tubs of mushrooms in growth medium, bags of dried mushroom material, sterilised grain bags and spores in liquid. In consultation with QPS, six exhibits were selected for illicit drug analysis. Fresh mushrooms were harvested a...
Introduction This computational modeling study introduces a novel Explainable Artificial Intelligence (XAI) framework for optimizing single-dose psilocybin treatment protocols through personalized intervention modeling using publicly available mental health datasets. All results presented are derived from novel simulated data and predictive modeling only, no...
The psychedelic mushroom Psilocybe cubensis is cultivated worldwide for recreational and medicinal use. Described initially from Cuba in 1906, there has been substantial debate about its origin and diversification. The prevailing view is that P. cubensis was inadvertently introduced to the Americas when cattle were introduced to the continent from Africa and...
Psilocybin is an emerging investigational compound with therapeutic potential in neuropsychiatric disorders, creating a need for flexible and scalable dosage forms suitable for early clinical development. This study aimed to develop and evaluate psilocybin-loaded oral thin film (OTF) formulations as a dose-proportional platform for early-phase clinical use. ...
To support ongoing clinical trials, the major human metabolites of psilocybin were synthesized on a preparative scale, specifically psilocin-O-glucuronide and 4-hydroxyindole-3-acetic acid (4-HIAA), along with putative minor metabolites and several deuterium-labeled derivatives. Psilocybin, psilocin, psilocin-O-glucuronide, and 4-HIAA were assayed for engage...
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...
Background: Major depressive disorder (MDD) is a highly prevalent and disabling psychiatric condition associated with substantial clinical, social, and economic burden [1,2]. Despite the availability of conventional antidepressants, their limited effectiveness, delayed onset of action, and high relapse rates have renewed interest in innovative therapeutic ap...
Psilocybin, a classic psychedelic compound, has garnered renewed interest as a potential treatment for various psychiatric disorders. This review provides a comprehensive overview of psilocybin's history, recent clinical evidence, ongoing clinical trials, neuroimaging findings, and regulations. Historically used in spiritual and healing rituals, psilocybin w...
BACKGROUND: Major depressive disorder (MDD) is the leading cause of disability worldwide, affecting roughly 322 million people. Recently, doses of psilocybin have shown promise in treating mood disorders, sparking interest in other dosing practices. According to anecdotal reports and observational studies, microdosing psilocybin yields benefits to mental hea...
MLS101 is being developed as a low dose psilocybin, that can be administered to treat neurological and psychiatric conditions. The purpose of this trial is to investigate brain activity, safety, tolerability, and PK of multiple doses of MLS101 in healthy participants. In recent years, high-dose psilocybin has gained attention for it potential therapeutic ben...
Psychedelic compounds, particularly psilocybin, have demonstrated remarkable therapeutic potential for mental health disorders through mechanisms involving structural neural plasticity. This comprehensive review examines recent breakthrough research revealing how psilocybin triggers activity-dependent rewiring of large-scale cortical networks. Using monosyna...
Recent advances in neuroscience have revealed unprecedented insights into how psilocybin, the psychoactive compound in magic mushrooms, induces therapeutic neural plasticity. This paper reviews groundbreaking research conducted by Cornell University and the Allen Institute for Brain Science, which employed genetically modified rabies virus for monosynaptic c...
Psilocin, a naturally occurring hallucinogenic component of magic mushrooms, exerts notable psychoactive effects in both humans and rodents. However, the underlying mechanisms remain not fully understood. Blood-oxygenation level-dependent (BOLD) functional magnetic resonance imaging (fMRI) is a valuable tool in many preclinical and clinical trials for invest...
