Introduction: Contemporary psychiatry is grappling with a profound stagnation in innovation. It is primarily relying on the chronic management of symptoms through traditional daily-dose pharmacotherapy. The emergence of psychedelics and ketamine marks a significant departure from this model. It is offering rapid-acting, interventional alternatives that targe...
This study aims to determine the safety and preliminary efficacy of psilocybin-assisted psychotherapy in improving alcohol-related outcomes among adults with severe alcohol use disorder in a a double-blind, dose-comparison concurrent control, randomized trial. Participants will undergo structured psychotherapy and will be randomized to two psilocybin session...
Background: This systematic review and meta-analysis evaluates the efficacy and safety of psilocybin-assisted psychotherapy (PAP) for adults with major depressive disorder (MDD). Methods: A PROSPERO-registered search (CRD42024561979) of CENTRAL, Scopus, PsycINFO, and MEDLINE (2010-2024) identified clinical trials assessing PAP. Risk of bias was assessed usin...
The purpose of this study is to understand whether psilocybin therapy is safe and well tolerated in improving chronic pain and increasing motivation to quit smoking for people who have chronic pain and smoke cigarettes. Psilocybin is a psychedelic drug and the active ingredient in "magic mushrooms." Psilocybin is currently being studied in clinical trials bu...
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...
Aims: Recently the therapies that utilize psychedelics have emerged as promising treatments for mood disorders, trauma-related disorders, and substance use disorders. While there is a growing body of research comparing various interventions directly, the majority of available research has been conducted in an indirect manner; therefore, Network Meta-Analysis...
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...
PURPOSE: Expectations strongly shape participant experiences in clinical trials, contributing to placebo effects that complicate interpretation of outcomes. While quantitative tools exist to measure expectations, their subjective and multidimensional nature, especially for individuals with treatment-resistant depression (TRD), remains underexplored. This stu...
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 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...
The primary purpose of this study is to evaluate the feasibility and estimate the efficacy of psilocybin-facilitated treatment for cocaine use. We also will monitor the impact of psilocybin-facilitated treatment on the use of other drugs and outcomes relevant to cocaine involvement. MRI assessment is a unique aspect of this study. As a potential biological m...
The goal of this randomized controlled trial is to evaluate the efficacy of psilocybin administered with Acceptance and Commitment Therapy (ACT) as an intervention to reduce post-traumatic stress disorder (PTSD) symptom burden in adult (aged 18-65) survivors of intimate partner violence (IPV). This trail will test the following 2 aims: AIM1: To compare the e...
Introduction and Objective.Treatment-resistant depression (TRD) remains a major clinical challenge affecting patients who fail to respond to at least two adequate antidepressant trials.The development of rapid-acting interventions targeting non-monoaminergic pathways has introduced new therapeutic possibilities.The aim of the review is to critically examine ...
To evaluate the efficacy, safety, and durability of a single 25-mg dose of a proprietary, synthetic formulation of psilocybin with psychological support for reducing chronic suicidal ideation in a treatment-resistant population. ), and ≥2 prior antidepressant treatment failures received a single 25-mg dose of psilocybin administered within a structured prepa...
Background: Treatment-resistant depression (TRD) affects a significant proportion of individuals with major depressive disorder and remains difficult to manage with conventional treatments. Psychedelic-assisted therapies and neuromodulation have emerged as innovative interventions targeting neurobiological mechanisms beyond traditional antidepressant approac...
Abstract Background: Conventional pharmacotherapy for treatment-resistant depression (TRD) has been found to provide limited benefit in a subset of patients. Psilocybin-assisted therapy has emerged as a promising modality due to its rapid-acting antidepressant effects and favourable tolerability profile shown in early trials. Despite growing research interes...
Interest in psychedelic-assisted therapy (PAT) is surging across research and medical communities, prompting the discussion of policy shifts that reflect growing openness to implementing psychedelics in clinical practice. State-level psychedelic reform in the United States has accelerated since 2019, with legalization projected to reach most states within th...
Classical serotonergic psychedelics, such as psilocybin, show emerging evidence of therapeutic potential across a range of mental health disorders, including depression, anxiety, and substance use disorders, with indications of transdiagnostic efficacy. While early-phase studies yielded encouraging results, recent larger-scale phase 3 trials, such as those e...
The goal of this clinical trial is to evaluate whether psilocybin therapy can effectively treat depression and psychological distress in adult patients with COPD, ALS, MS, or APD who have at least 6 months life expectancy. The main questions it aims to answer are: * Can psilocybin therapy safely reduce depressive symptoms compared to low-dose control? * Will...
Introduction and purpose: Depressive disorders, particularly major depressive disorder (MDD) and treatment-resistant depression (TRD), remain major causes of disability worldwide. Conventional treatments are limited by delayed onset, incomplete response, relapse, and adverse effects. This review summarizes current evidence on the efficacy, safety, and durabi...
