The purpose of this multi-site randomized controlled trial is to evaluate the efficacy and risks of psilocybin for the treatment of depression in U.S. military Veterans with and without (±) concurrent posttraumatic stress disorder. Treatment-resistant depression (TRD) is a serious mental health problem in Veterans, frequently comorbid with post-traumatic str...
Background: Understanding the benefits of psychedelic-assisted therapy (PAT) will require scientific attention to the causal interaction between the therapeutic context and process. Measuring what actually happens during PAT in large-scale studies will be an essential component of this work. Objective: We aim to develop and preliminarily evaluate the feasibi...
The purpose of this study is to determine the importance of the acute subjective experience induced by psilocybin (the primary component of "magic mushrooms") in facilitating positive outcomes. Participants in this study will be given psilocybin in combination with either a placebo or risperidone, an atypical antipsychotic that block the subjective effects o...
Approximately 240 eligible adult participants (≥18 years old) who meet Diagnostic and Statistical Manual of Mental Disorders (DSM-5-TR) criteria for Major Depressive Disorder (MDD) will be enrolled. Participants will be randomly assigned to receive a single oral dose of Psilocybin 25 mg, Psilocybin 5 mg, or inactive placebo. The purpose of this study is to e...
This phase II trial tests the safety, side effects and how well group retreat psilocybin therapy works for the treatment of anxiety and depression in patients with solid tumors that have spread from where they first started (primary site) to other places in the body (metastatic) or with hematologic cancers for which no treatment is currently available (incur...
A single dose of psilocybin may provide rapid relief for people with major depressive disorder (MDD), with benefits emerging within days and lasting for several weeks, according to a randomized clinical trial published May 15 in JAMA Network Open. Researchers of the study, “Short-Term and Late-Term Effects of Psilocybin on Symptoms in Major Depression: A Ran...
Patients with treatment-resistant depression who received psilocybin-assisted psychotherapy showed clinically meaningful improvement in depressive symptoms relative to placebo, a Phase 2b trial has found. However, the study did not show a significant effect on the primary outcome of treatment response 6 weeks after the first of two doses of psilocybin. Study...
Abstract Background and Aims Psilocybin-assisted psychotherapy (PAP) is a novel, transdiagnostic treatment in which the 5-HT2A receptor agonist psilocybin is combined with psychotherapy. Studies to date have evaluated PAP's effects on depression, substance use, and end-of-life adjustment. Relatively less attention has been given to its effects on anxiety sym...
Serotonergic psychedelics are increasingly investigated as treatments for affective disorders. Concerns persist regarding their potential to induce hypomania or mania, particularly in individuals with bipolar spectrum vulnerability. Whether these substances precipitate transient mood switches or contribute to persistent bipolar illness or diagnostic transiti...
Maintaining effective blinding is a major methodological challenge in psychedelic research. This study provides a comprehensive evaluation of blinding integrity in 120 healthy volunteers who received either psilocybin, MDMA, or methylphenidate (active placebo) in a double-blind, randomized controlled trial. Using a multi-level assessment incorporating forced...
BACKGROUND: Psilocybin is among the serotonergic psychedelics closest to potential FDA approval, with growing evidence of therapeutic benefit across psychiatric conditions. As clinical trials expand, systematic characterization of adverse events (AEs) remains essential. While transient hypertensive responses are well documented, hypotensive events such as ne...
INTRODUCTION: Psilocybin shows promise for treatment-resistant depression (TRD), but long-term data are limited. This study examined the antidepressant effect of one or two psilocybin doses with adjunct psychotherapy in TRD until twelve months. METHODS: This is a naturalistic follow-up of a phase 2b, randomized, active placebo-controlled trial, where partici...
The serotonergic hallucinogen psilocybin has shown potential as a treatment for psychiatric conditions like alcohol use disorder (AUD) and depression in clinical studies. Epigenetic mechanisms, including DNA methylation, are hypothesized to contribute to its lasting therapeutic benefits. In this exploratory study, we present the first methylome-wide analysis...
ABSTRACT Treatment-resistant depression (TRD) is characterized by chronic symptoms, impaired functioning, and limited response to conventional antidepressant therapy. Contemporary reviews have highlighted increasing interest in psilocybin-assisted therapy as a mechanistically novel approach for depressive disorders, grounded in early feasibility work demonst...
The purpose of this review is to evaluate the possible benefits of using psilocybin(C12H17N2O4P), a naturally occurring psychoactive compound found in certain species of mushrooms, in the treatment of multiple forms of mental illness and substance abuse in either monotherapy or in conjunction with traditional psychiatric medications. The compound acts as a h...
Psychological distress, such as anxiety and depression, is common among people with cancer and is often worsened by existential worries about mortality, loss of meaning, and decreased quality of life. Standard treatments, including medication and psychotherapy, often offer limited or short-term relief, highlighting the need for new, integrative psychosocial ...
This study is a community-informed, pragmatic, open-label, phase 1 clinical trial of group-format psilocybin-assisted therapy (GPAT) for individuals with post-traumatic stress disorder (PTSD). The primary objectives of this phase 1 study are to assess the safety and feasibility of (GPAT) for individuals with (PTSD) and to evaluate preliminary effects on PTSD...
The primary objectives of this clinical investigation are to (1) determine the acceptability and feasibility of joining psilocybin-assisted therapy with cognitive-behavioral therapy (PA-CBT) for patients with depression, (2) optimize CBT to most effectively integrate the psilocybin experience with psychotherapy and (3) examine the clinical benefit of psilocy...
