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...
Results of new psychedelic research aimed at patients with severe treatment resistant depression (TRD) found significant decreases in their depressive symptoms. Researchers of the open-label study also found significant safety and efficacy of synthetic psilocybin in TRD patients.
Psychedelics have emerged as a promising approach to treating mental disorders, challenging traditional paradigms in psychiatry. This study conducted an integrative literature review to investigate the advances, challenges, and implications of the therapeutic use of these substances, addressing the guiding question: “What are the current scientific perspecti...
Although psychedelics were banned from medical research for about fifty years, recent early-phase studies indicate they may offer unique therapeutic benefits for various mental health and substance use disorders. When effective, psychedelic experiences often involve phenomena not typically observed in other medical or psychiatric interventions, such as a dim...
Background: Psychedelic-assisted therapy (PAT) is experiencing a resurgence, with expanding evidence proving its efficacy for treatment-resistant psychiatric-mental health conditions. Psychiatric-mental health nurses (PMHNs) are uniquely positioned to provide PAT due to their integrated care capabilities, yet their roles are poorly defined. Aim: This review ...
Serotonergic psychedelics induce their characteristic subjective effects via activation of the serotonin 2A receptor (5-HT2AR). This structurally diverse class of drugs includes ergolines (e.g., LSD), phenethylamines (e.g., mescaline), and tryptamines (e.g., psilocin), all of which have NPS analogues that have emerged on recreational drug markets. Importantl...
The goal of this clinical trial is to learn if PEX010 is effective for the treatment of Stimulant Use Disorder in adults. The study will also assess the safety and feasibility of administering PEX010 to this population. The main questions it aims to answer are: Does PEX010 reduce stimulant use? What medical problems do participants experience when taking PEX...
This study is an open-label, single-arm, proof-of-concept study, wherein treatment resistant bipolar depression (TRBD) participants will receive one 25 mg dose of oral psilocybin accompanied by preparatory, monitoring, and integration psychotherapy sessions (psilocybin-assisted psychotherapy, or PAP). Using fMRI (functional magnetic resonance imaging), the f...
There is some evidence that the subjective effects of ketamine and other psychedelics like psilocybin are crucial for their therapeutic outcomes, such as treatment of depression or substance use disorder (SUD). We performed a meta-analysis and systematic review on the correlation of subjective symptoms and dissociation versus ketamine-induced therapeutic out...
Title: Use of psilocybin in the treatment of mental disorders: systematic review of clinical trials. Objective: To evaluate the high-impact evidence on the neurobiology, efficacy, safety, and feasibility of using psilocybin in the treatment of mental disorders such as depression, anxiety, obsessive-compulsive disorder (OCD), post-traumatic stress disorder (P...
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...
