Psilocybin, a tryptamine-derived alkaloid from Psilocybe mushrooms, has emerged as a high-value biopharmaceutical candidate due to its promising applications in mental health. While clinical studies highlight its rapid and sustained antidepressant effects, current challenges lie in achieving scalable, reproducible, and cost-effective production to meet growi...
BackgroundExisting tools assess psychedelic experiences, but none specifically measure altered processing of traumatic memories-a key mechanism in trauma-focused therapies and psychotherapy in general. The helioscope effect describes how psychedelics like psilocybin and 3,4-methylenedioxymethamphetamine (MDMA) enable revisiting challenging or traumatic exper...
The goal of this randomized controlled trial is to evaluate the safety, feasibility, and efficacy of psilocybin assisted therapy as an intervention to reduce symptom burden in adult patients (aged 18-65) with persisting symptoms after concussion (PSaC). This trail will test the following 2 aims: AIM1: To test the safety and feasibility of an active psilocybi...
This trial aims to examine the safety and efficacy of small (2mg) sub-hallucinogenic doses of psilocybin in people with Major Depressive Disorder. This protocol is for a University of Toronto - sponsored, randomized, placebo-controlled crossover phase 2 study of the safety and efficacy of low doses of psilocybin in subjects with depressive symptoms who meet ...
ClinicalTrials.gov2025-12-29Rotem Petranker
ClinicalTrials.govCLINICAL TRIALpsilocybinDepressionMicrodosingClinical TrialObservational StudySafetyClinical TrialMajor Depressive DisorderPsilocybin first
Distinguishing metabolite isomers often relies on comparing relative data, such as relative chromatographic retention times and ion mobility arrival time orders, or relative product ion abundances. These approaches necessitate the need for quality reference data and/or chemical standards. An ideal method for differentiating isomers would leverage one of the ...
Psilocybin, an indole alkaloid of psychedelic mushrooms, has the potential to sustainably improve the treatment of several psychiatric diseases. So far, the psilocybin demand for clinical trials has been met by chemical synthesis. In this study, we pursued the biotechnological approach to develop a psilocybin production process utilizing an overproduction st...
The purpose of this research study is to investigate whether a single administration of psilocybin can improve interoceptive awareness (awareness of bodily sensations) in individuals with chronic low back pain undergoing physical therapy, and whether these improvements are linked to pain relief and better physical therapy outcomes. Preclinical and human stud...
ClinicalTrials.gov2025-12-28Yale University
ClinicalTrials.govCLINICAL TRIALpsilocybinAddictionChronic PainMechanism of ActionAnimal StudyClinical TrialChronic Low Back Pain (CLBP)Physical Therapy
Background: Psilocybin has shown promise in neuropsychiatric disorders but presents a paradoxical relationship with seizures and epilepsy. Methods:: A narrative review was conducted up to November 23, 2025. We conducted structured literature searches across PubMed/MEDLINE, Scopus, Web of Science. and Google Scholar using MeSH terms and keywords to identify s...
Background: Psychedelic-assisted therapy is gaining renewed attention as a potential treatment for various mental disorders. Despite increasing numbers of randomized controlled trials (RCTs) and meta-analyses, a comprehensive synthesis of the evidence across different substances and indications is lacking. This umbrella review aims to evaluate the effectiven...
The therapeutic potential of low, non-psychedelic doses of psilocybin, a fungal tryptamine alkaloid, was investigated in metabolic disorders including obesity, type 2 diabetes mellitus (T2DM), and liver steatosis. Mice fed a high-fat/high-fructose diet received chronic treatment with psilocybin (0.05 mg/kg) for 12 weeks. Body weight, liver histology, insulin...
Unknown journal2025-12-28Colognesi M, Gabbia D, Signor A, Sarill M, Centofanti L, Rinaldi A, Cascione L, Nunziata S, Banzato M, Mattarei A, Finzi G, Sonda S, Pendin D, Zanotto I, Comai S, Pasut G, Alajati A, Saponaro M, Bucciarelli L, Lunati ME, Guarato G, Goggi I, La Rosa S, Morano C, Paroni RC, Dei Cas M, Daniele G, Gentilucci M, Pappagallo M, Alimonti A, Manfredi PL, Folli F, De Martin S.
Europe PMCPublishedpsilocybinPharmacologyMechanism of ActionReceptor PharmacologyAnimal StudyTranscriptomicsAnimal StudyLiverAnimals
Psychedelic use has greatly increased within clinical and recreational settings over recent years. While demonstrating a favorable safety profile within certain clinical populations, little empirical research has explored safety of psychedelic use within real-world samples. Using the World Health Organization (WHO) VigiBase, a comprehensive global pharmacovi...
ObjectiveThe goals of this study were to examine the therapeutic effects and safety of psilocybin given as a pulsed regimen for the prevention of migraine and to consider the blinding integrity of an active control agent.BackgroundThe administration of a single low dose of psilocybin was observed to have lasting therapeutic effects in one small pilot trial i...
ABSTRACT Clinical trials suggest that a single dose of psilocybin is an effective treatment for substance use disorders (SUDs). Choice impulsivity is a value-based decision-making bias that predicts drug-intake escalation and is commonly associated with SUDs. The dorsomedial prefrontal cortex (dmPFC) regulates choice impulsivity and is enriched with 5-HT2A r...
Psychedelic compounds significantly reshape conscious perception, yet the implications of these alterations for complex visual-guided behaviors remain poorly understood. We investigated how psilocybin modulates visual salience processing during natural scene perception. Twenty-three participants completed eye-tracking tasks under self-blinded low and high do...
Psychedelics such as psilocybin, LSD, and MDMA have shown promise in treating mental health conditions (e.g., depression, post-traumatic stress disorder) among neurotypical individuals, i.e., typically developing individuals without a diagnosed neurodevelopmental condition. However, their therapeutic potential for treating co-occurring mental-health conditio...
BackgroundThe Altered States of Consciousness Scale (3/5D-ASC or 11-ASC) is widely used to assess non-ordinary states of consciousness, particularly for psychedelic research. However, its original dimensional model (3D-ASC within 5D-ASC) and later 11-subscale structure (11-ASC) have a hierarchically incompatible higher/lower-order structure. Although the 11-...
This study aims to explore the safety and tolerability of a single dose of psilocybin (25mg) administered under supportive conditions to adult participants with TRD and chronic suicidal ideation
ClinicalTrials.gov2025-12-23Sheppard Pratt Health System
The primary objective of the study is to evaluate the safety and efficacy of psilocybin in adults with major depressive disorder (MDD) and borderline personality disorder (BPD). The primary objective of the proposed study is to evaluate the safety and efficacy of psilocybin in adults with major depressive disorder (MDD) and borderline personality disorder (B...
Background Psychedelics exert widespread effects on brain activity, but their impact on motor function is unclear. This is clinically relevant given the emerging interest in psychedelic-assisted physical therapy for disorders of motor function. This study’s primary objectives examined the feasibility and safety of administering movement tasks following low-t...
medRxiv2025-12-22Bhagavan C, Carter O, Nielsen G, Berlowitz D, Issak S, Braat S, Zaloumis S, Attard Z, Oliver G, Mayne D, Rucker J, Butler M, Dandash O, Bryson A, Kanaan RA.
Classic psychedelics and related substances, such as 3,4-methylenedioxymethamphetamine (MDMA), have again become a focus of interest in psychiatry as potential therapeutic tools. The aim of this paper is to review current data on their mechanisms of action, clinical applications in the treatment of mood and anxiety disorders, addictions and post-traumatic st...
Unknown journal2025-12-22Liszka P, Ogórek A, Olejnik-Chlewicka KM, Puchalski K, Zasiadła M, Patrzykąt KM, Perediatkiewicz J, Urbański W, Łuczak PM, Brodowski J.
Europe PMCPublishedpsilocybinDepressionAnxietyPTSDAddictionMechanism of ActionReceptor PharmacologyEmotional ProcessingClinical TrialReview ArticleCancer PatientsTreatment-Resistant DepressionSafetyDrug InteractionsClinical Trial