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...
The study aims to investigate the safety and efficacy of oral psilocybin administered under supportive conditions in treatment-resistant major depression (TRD). The study is a bi-centric, prospective, randomized, active placebo-controlled study investigating the effects of 25 mg and 5 mg (p.o.) psilocybin versus placebo (100 mg nicotinamide) in a psychothera...
Purpose of reviewChronic pain affects approximately 1.5 billion people worldwide, representing the leading cause of disability and a significant financial burden on healthcare systems. Conventional treatments, such as opioids and non-steroidal anti-inflammatory drugs, are frequently linked to adverse effects, including dependency and gastrointestinal issues,...
The purpose of this study is to determine the safety, tolerability, and feasibility of psilocybin therapy for depression and anxiety in people with Parkinson's disease. This is an open-label single-arm pilot study of oral psilocybin therapy for depression and anxiety in people with Parkinson's Disease (PD). The primary goal is to examine safety, tolerability...
People living with cancer (PLWC) often face profound existential distress that is insufficiently addressed by conventional psychosocial supports. This qualitative study explored PLWC's attitudes, beliefs, and experiences regarding psychedelic-assisted therapy (PAT) as a novel approach to addressing psychosocial suffering, particularly existential distress. F...
The revival of psilocybin in psychopharmacological research heralds a potential paradigm shift for treating mood and anxiety disorders, and other psychiatric conditions beyond the psychotic spectrum. This critical review evaluates current evidence on psilocybin's efficacy, juxtaposing potential benefits with the practical aspects of psychedelic-assisted psyc...
Background: Negative perceptions of psilocybin and challenges of participant enrollment may represent barriers to conducting a randomized controlled trial examining psilocybin for chronic neuropathic pain. Aim: Prior to trial initiation, we aimed to examine patient attitudes toward the trial via a prospective preference assessment. Methods: Twenty-six patien...
Fibromyalgia (FM) is the prototypical nociplastic pain condition, characterized by widespread pain and issues with cognition, mood, and sleep. Currently, there are limited treatment options available that effectively treat FM symptoms. Psilocybin-assisted therapy (PAT) is an emerging combined drug-therapy intervention, but no studies to-date have investigate...
Fibromyalgia (FM) is the prototypical nociplastic pain condition, characterized by widespread pain and issues with cognition, mood, and sleep. Currently, there are limited treatment options available that effectively treat FM symptoms. Psilocybin-assisted therapy (PAT) is an emerging combined drug-therapy intervention, but no studies to-date have investigate...
Psilocybin, a psychoactive substance, has recently garnered attention for its high therapeutic potential in psychiatry. In this study, we investigated the multifaceted aspects of psilocybin, highlighting its chemical properties, mechanisms of action, and burgeoning role in psychiatric treatment. Furthermore, we examined the clinical applications and potentia...
The purpose of this study is to determine the safety and feasibility of performing psilocybin-assisted psychotherapy in patients hospitalized for treatment-resistant depression. The proposed study will assess the safety, feasibility, preliminary results and neurological aspects of psilocybin-assisted psychotherapy in the treatment of hospitalized patients wi...
Abstract Background A diagnosis of cancer is often associated with significant psychological distress. Current approaches to cancer-related distress predominantly fall short of meeting the needs of patients. Recent investigations have shown that administering psilocybin in combination with psychotherapy might be effective at reducing distress in cancer patie...
The goal of this multi-centre phase I/II open-label, single-arm study is to determine the safety, feasibility, therapeutic dose, and preliminary efficacy of psilocybin microdosing to treat psychological distress among patients with advanced illness. Forty patients will receive psilocybin drug product (1-3mg per day, Mon-Fri) for 4 weeks to be administered vi...
Psilocybin has reemerged as a promising treatment for difficult-to-treat depression (DTD). Although there is limited evidence regarding interactions between psilocybin and other psychotropic drugs, clinical trials require that patients discontinue their antidepressants before study entry to isolate the benefits of psilocybin and to minimize the risk of adver...
Introduction: Studies of psychedelic-assisted therapy with LSD, psilocybin, MDMA, and related substances show clinical promise but inadequately assess side effects. Measuring side effects is challenging because they are not always easily differentiated from treatment effects or disease symptoms and show high heterogeneity, variable duration and impact, and s...
Introduction: Studies of psychedelic-assisted therapy with LSD, psilocybin, MDMA, and related substances show clinical promise but inadequately assess side effects. Measuring side effects is challenging because they are not always easily differentiated from treatment effects or disease symptoms and show high heterogeneity, variable duration and impact, and s...
The purpose of this study is to see if one or two doses of psilocybin is more effective in relieving depressive symptoms in patients with treatment-resistant depression (TRD). Researchers also want to know if a second dose of psilocybin is safe and well-tolerated. This study will see if psilocybin is effective, safe, and well-tolerated by tracking changes in...
Introduction Recently, the pros and cons have been debating in Korea even before the approval of use of medical marijuana with very strict limitations. And the next controversial topic is psychedelics. In 1890, when mescaline was first isolated from peyote cactus, clinical researches began, but due to its harmful effects, it was thereafter legally prohibited...
Psilocybin is the most researched classic psychedelic for Treatment-Resistant Depression (TRD). While optimizing set and setting are considered essential for efficacy and safety, patient perspectives on these aspects have rarely been investigated. To address this knowledge gap, the current paper explored the experiences of 11 TRD patients (8 women, 3 men) pa...
Despite significant advances in symptom management for patients affected by serious illness, physicians lack effective legal treatments for individuals suffering from demoralization, death anxiety, and existential distress. Psilocybin-assisted psychotherapy employs psilocybin-containing mushrooms or synthetic psilocybin grounded in indigenous traditions and ...
