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. ...
Selective serotonin reuptake inhibitors (SSRIs) are widely prescribed for mood and anxiety disorders, the same conditions under which psychedelic-assisted therapies are gaining renewed interest. However, it remains unclear how SSRI treatment may influence sensitivity to psychedelics, particularly through the shared engagement of serotonergic pathways. Here, ...
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...
INTRODUCTION: Psychedelic-assisted therapy shows promise for treating various mental health conditions; however, its reliance on intensive psychological preparation limits its broader application. Digital health interventions have the potential to address this limitation by providing structured, accessible and scalable preparation solutions. This randomised ...
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...
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...
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...
Psychedelic-assisted therapy (PAT) is increasingly investigated as a treatment for depression, post-traumatic stress disorder (PTSD), and substance use disorder. In the United States (US) and European Union, esketamine has been approved for the treatment of depression, while psilocybin and 3,4-methylenedioxymethamphetamine (MDMA) have received Breakthrough T...
Psilocybin is a psychoactive tryptamine produced by a phylogenetically discontinuous yet ecologically diverse subset of fungi. Despite decades of chemical, pharmacological, and ethnobiological research, the evolutionary forces driving the emergence and persistence of this compound remain insufficiently explained. Recent hypotheses proposing that psilocybin e...
This manuscript comprehensively reviews psilocybin-assisted therapy for major depressive disorder and treatment-resistant depression. It aims to synthesize current understanding regarding its mechanisms, efficacy, safety, costs, and accessibility, comparing it with conventional antidepressant and ketamine treatments. The methodology involved a narrative synt...
BACKGROUND: Recent advancements in psychedelic research have highlighted psilocybin's potential therapeutic benefits for various mental disorders. Understanding its effects on brain function and identifying predictors of individual responses are essential for developing effective treatments. METHODS: This double-blind, randomized, crossover, and placebo-cont...
Psilocybin-assisted therapy (PAT) is an emerging intervention for depression. Though several clinical trials report promising results for PAT in treating depression, there remains a need for consensus on optimal methodologies and standardization of PAT protocols. The objective of this review was to assess the efficacy of PAT in treating depressive symptoms a...
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 are a diverse class of psychoactive compounds that profoundly alter perception, cognition, and emotional states. Recently, classical serotonergic agents, such as psilocybin and lysergic acid diethylamide (LSD), along with atypical agents such as methylenedioxymethamphetamine (MDMA, ecstasy) and ibogaine, have attracted renewed attention due to t...
Current neuroscience research calls into question the binary model of anesthesia as a state of consciousness shifted by unconsciousness, replacing it with an idea of consciousness as a continuum created by interactions between large-scale cortex and subcortical regions.Meanwhile, psychedelic drugs are making a comeback as potential treatments for treatment-r...
