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...
The pressing need for effective fibromyalgia (FM) treatments, the known safety of psilocybin therapy, and the mechanistic plausibility for potential benefit provide a backdrop for investigating psilocybin therapy as a treatment for FM. The primary objective of this study is to evaluate the clinical benefit of oral psilocybin in concert with psychotherapy to ...
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...
Psilocybin, a naturally occurring psychedelic compound, has garnered renewed scientific interest for its potential in treating psychiatric and neurological disorders. This review systematically examines the latest research on psilocybin's pharmacokinetics, pharmacodynamics, clinical efficacy, and safety profile. Emerging evidence supports its efficacy in con...
Psilocybin, a tryptamine-derived alkaloid, has been granted Breakthrough Therapy designation by the U.S. FDA for treatment-resistant depression, underscoring its clinical importance. Therefore, sustainable and economic production is urgently needed. Manufacturing of psilocybin in Escherichia coli has drawn great attention. However, due to the low expression ...
OBJECTIVE: To compare changes in depression, anxiety, and suicidality symptoms after a single 25 mg oral dose of psilocybin between treatment-resistant depression participants not on antidepressants at screening to participants that discontinued antidepressant medications leading up to receiving psilocybin-assisted psychotherapy (PAP). METHODS: Participants ...
There has been a recent resurgence in research on psychedelics as therapeutic agents for psychiatric conditions. This leading article outlines the studies to date of classic psychedelic treatments for treatment-resistant depression and major depression, including psilocybin, ayahuasca, dimethyltryptamine (DMT), and O-methyl-bufotenine (5-Me-O DMT). We discus...
The purpose of this review is to provide a comprehensive overview of the current findings and data on the therapeutic effects of psilocybin, a naturally occurring psychedelic alkaloid primarily found in Psilocybe mushrooms. This review covers psilocybin's efficacy and safety profile, therapeutic effects, proposed indications and contraindications, drug-drug ...
Psilocybin, MDMA, and LSD have recently emerged as popular psychedelic substances for use in psychopharmacology in managing various disorders including treatment-resistant depression, PTSD, and anxiety. These substances mainly affect the serotonergic receptors that involve the regulation of consciousness, perceptions, and cognition. These unique alterations ...
IntroductionAs depression rates continue to rise globally, the need for more effective and innovative treatments has become increasingly urgent, highlighting the potential impact of psilocybin as a promising therapeutic option. However, to ensure its safe and effective integration into clinical practice, it is essential to establish robust safety parameters ...
The growing interest in psychedelic-assisted therapy (PAT) for treating psychiatric disorders such as treatment-resistant depression, PTSD, and anxiety has led to an increasing demand for specialized training. In Switzerland, MDMA, psilocybin, and LSD are applied in the framework of limited medical use as exceptional treatment options since 2014. The Swiss M...
Brain aging (BA) processes are complex, often affect multiple systems, and frequently lead to cognitive decline and increased susceptibility to insults. BA appears to be a primary risk for the development of many prominent neurodegenerative pathologies. The US Census Bureau predicts that the aging population (65+) will represent a greater proportion of the U...
The largest randomized study of psilocybin to date demonstrated the efficacy of COMP360 25 mg (Compass Pathways' investigational proprietary pharmaceutical-grade synthesized psilocybin formulation) in participants with treatment-resistant depression (COMP001), compared with 10 mg and 1 mg doses. Here, we report findings from COMP004, a 52-week observational ...
There is a growing body of clinical research on the therapeutic potential of psychedelics for the treatment of mental health disorders, notably depression. Accordingly, the new revision of the European Medicines Agency guideline on the clinical investigation of products for depression will incorporate a section covering specific regulatory recommendations fo...
Background/Objectives: Non-response to initial treatment options for major depressive disorder (MDD) is a common clinical challenge with profound deleterious impacts for affected patients. Few treatments have received regulatory approval for treatment-resistant depression (TRD). Methods: A systematic search of United States and European Union clinical trials...
IntroductionA substantial number of patients exhibit treatment-resistant depression (TRD), posing significant challenges to clinicians. The discovery of novel molecules or mechanisms that may underlie TRD pathogenesis and antidepressant actions is highly needed.Areas coveredUsing the PubMed database, the authors searched for emerging evidence of novel approa...
