Depressive disorders continue to pose a major clinical challenge worldwide, particularly given the high prevalence and increasing number of treatment-resistant cases. Over the past decade, advances in research have elucidated the antidepressant potential of psilocybin and other 5-HT₂A receptor agonists in patients with major depressive disorder (MDD) and tre...
Abstract Major depressive disorder (MDD) is a leading cause of disability that affects over 300 million people globally. Despite multiple antidepressant trials, approximately one-third of MDD patients remain symptomatic, progressing to treatment-resistant depression (TRD). This persistence possibly is due to the multifaceted etiology of TRD, encompassing bio...
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...
IntroductionAlthough long known for their psychoactive effects, psychedelic drugs have only recently been investigated for medicinal use. Psilocybin has attracted the greatest interest with studies suggesting that it may be a useful agent in psychiatry and in palliative care.Areas coveredClinical trials that included psilocybin were searched in PubMed, Embas...
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 ...
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 ...
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...
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...
Integrating advanced pharmaceutical innovations and artificial intelligence (AI) offers transformative potential for psychiatric care. This Patent Highlight reviews novel therapeutic strategies, including the synergistic use of monoamine antidepressants and short-duration psychedelics, alongside AI-driven behavioral efficacy tracking. The combination of sele...
Depressive disorders present an enormous global public health burden. A notable treatment gap exists between the prevalence of depression and our ability to provide rapid-acting, effective treatment that achieves remission. Brexanolone and zuranolone, the first US Food and Drug Administration-approved drugs for postpartum depression, signify a critical advan...
Interest in psychedelic therapies for adults is rapidly growing, with substances like 3,4-methylenedioxymethamphetamine for posttraumatic stress disorder, psilocybin for treatment-resistant depression, and lysergic acid diethylamide for generalized anxiety disorder showing promise. However, research on these therapies in children and adolescents is limited, ...
Introduction: In recent years, psilocybin has been explored as an alternative therapy for neurological and psychiatric disorders, such as depression, anxiety, post-traumatic stress disorder (PTSD), and substance dependence. Studies suggest that when administered under professional supervision, psilocybin can offer relief for patients with treatment-resistant...
Purpose of reviewThere is a mental health crisis affecting youth, and the utility of existing treatments is often limited by lack of effectiveness and tolerability. The aim of this review is to report on outcomes of clinical trials for psilocybin-assisted psychotherapy for adults with depression and MDMA-assisted psychotherapy for adults with post-traumatic ...
Psilocybin is a psychedelic tryptamine that has emerged as a potential candidate for the treatment of a variety of conditions, including treatment resistant depression and post-traumatic stress disorder. Clinical trials which have assessed the efficacy of psilocybin for these conditions report a rapid and sustained improvement in patient- and clinician-rated...
