The primary objective of this study is to evaluate the efficacy of psilocybin (25 mg) administered under supportive conditions to adult participants with severe TRD, in improving depressive symptoms.
Abstract Effective interventions for neuropsychiatric disorders may work by rebalancing the brain’s functional hierarchical organization. Here we directly investigated the effects of two different serotonergic pharmacological interventions on functional brain hierarchy in major depressive disorder in a two-arm double-blind phase II randomized controlled tria...
Growing evidence suggests that the race and ethnic minority population may experience fewer protective effects of psychedelics on mental health. The minority diminished psychedelic returns theory proposes that racism, manifested in socioeconomic inequality, could partially account for the smaller health gains observed. Therefore, it is important to investiga...
Introduction: Mental disorders are common and still growing problem around the globe. Significantly decreasing quality of life, they are often source of true suffering for patients and their families leading to further health issues or even dramatic outcomes resulting in death. As public awareness rises, more and more people understand risks and tend to look...
A New York-based organization, considered a global leader in professional education and training for psychedelic therapy research, is collaborating with a biotechnology company to develop an FDA-approved botanical psilocybin pharmaceutical candidate to support an upcoming randomized clinical trial.
Abstract The mechanisms by which Psilocybin Therapy (PT) improves depression remain an important object of study, with scientists actively exploring acute psychological experiences and neurobiological processes as candidates. In a phase 2, double-blind, randomized, active comparator controlled trial involving patients with moderate-to-severe major depressive...
Psilocybin is a serotonergic psychedelic shown to have enduring antidepressant effects. Currently, the mechanism for its enduring effects is not well understood. Empathy and prosocial behavior may be important for understanding the therapeutic benefit of psilocybin. In this article we review the effect of psilocybin on empathy and prosocial behavior. Moreove...
Introduction and purpose:
 Nowadays, when mental disorders are considered by the World Health Organisation as a global burden, the potential usage of psychedelic drugs as supportive therapy is gaining more attention worldwide. The aim of this paper is to summarize the usefulness of psilocybin - representative of psychedelics - in psychiatric venues. In ...
LAY SUMMARY The historical relationship between psychedelic drugs and the military has often been characterized in terms of drug misuse or the connection between drugs like d-lysergic acid diethylamide (LSD) or psilocybin (magic mushrooms) contributing to anti-war sentiments. Recent clinical evidence, however, suggests these cultural associations may be over...
LAY SUMMARY Patients with headache disorders, such as migraine or cluster headache, often have poor quality of life and can be disabled by their condition. Military members and Veterans have a high risk of developing a headache disorder, particularly because they are also at risk for brain injury through head trauma. New headache treatments are needed, becau...
Psilocybin is a naturally occurring hallucinogen found in different species of fungi. Psilocybin has gained extensive social popularity and political attention in the United States. Research has shown that psilocybin and psychological therapy may have promising therapeutic applications for safer and more effective treatment of mental illnesses such as major ...
This perspective paper explores the choice of psychotherapy for psilocybin-assisted psychotherapy for treatment-resistant depression. There is evidence to support the use of some psychotherapies in treating 'treatment-resistant' depression, and emerging evidence for the efficacy of psilocybin. The next step which is the focus of this paper is to identify psy...
Introduction: The word “psychedelic” derives from the Greek language and can be loosely translated as “mind manifesting” which is to convey that these substances allow the mind to unleash its hidden potential. Psilocybin is considered to be a “classic psychedelic” and is most commonly found in the form of so-called “magic mushrooms”. Due to its unique proper...
In this review paper, we delve into the potential applicability of psilocybin - a naturally synthesized psychedelic substance found within select species of fungi, as a prospective avenue for depression treatment. Depression, a widespread psychological malady affecting countless individuals across the globe, often proves stubborn against existing treatment m...
Observing that designing clinical studies to evaluate the safety and effectiveness of psychedelic substances presents a number of unique challenges that require careful consideration to the industry, the U.S. Food and Drug Administration (FDA) last month issued, for the first time, draft guidance for conducting clinical trials with psychedelic drugs such as ...
Psychedelics such as psilocybin reliably produce significantly altered states of consciousness with a variety of subjectively experienced effects. These include certain changes to perception, cognition, and affect, 1 which we refer to here as the acute subjective effects of psychedelics. In recent years, psychedelics such as psilocybin have also shown consid...
The COVID-19 pandemic has resulted in a surge in depression cases, a pervasive and debilitating mental illness1. This trend is evident in the increased prescriptions for antidepressants. Depression is a chronic condition that affects a significant proportion of the global population, with ~280 million people, or about 3.8%, suffering from it. As a result, it...