A Phase 2b/3, Multicentre, Randomised, Double-blind, Controlled Trial, With an Open Label Extension, to Investigate the Efficacy, Safety, and Tolerability of COMP360 in Participants With Post-traumatic Stress Disorder

The Redefine Study (COMP202) is testing COMP360 to see if it may reduce post-traumatic stress disorder (PTSD) symptoms when administered alongside monitoring and support from a trained study team. COMP360 is a lab-made form of the naturally occurring chemical compound psilocybin.

Rapid-acting interventions in treatment-resistant depression - a comparative review of esketamine and psilocybin

Safety and Efficacy of Psilocybin in the Management of Treatment-Resistant Depression: A Systematic Review

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...

Psilocybin in Older Adults: Therapeutic Opportunities in Inflammation-Driven Disorders of Aging-From Depression to Neurodegeneration.

Aging is associated with chronic, low-grade inflammation ("inflammaging"), which contributes to neuropsychiatric and neurodegenerative disorders such as depression, Alzheimer's disease, and Parkinson's disease. Conventional pharmacotherapies often provide limited benefit in older adults and are further complicated by polypharmacy and drug-drug interactions. ...

The Safety and Efficacy of Psilocybin Therapy Compared to Low-dose Control in Reducing Depressive Symptoms in Patients With COPD, ALS, MS, or APD.

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...

Characterizing Resting-State Brain Dynamics with Frequency-Resolved EEG Microstates: Parallel Analyses of Psilocybin Microdosing and Acute Inhaled DMT

Electroencephalographic (EEG) microstates provide a compact framework for characterizing the temporal organization of large-scale brain activity, yet their sensitivity to altered brain states remains insufficiently explored. In this study, we applied broadband and frequency-resolved EEG microstate analysis to resting-state EEG data from two publicly availabl...

1020 Long-term Impact of Psilocybin Administration on Sleep-Continuity via Wearable Sensor Time-series: Preliminary-results in Post-Treatment Lyme Disease

Abstract Introduction Post-treatment Lyme Disease (PTLD) is a post-infectious syndrome characterized by fatigue, hypersomnia, sleep-disturbance, musculoskeletal pain and/or cognitive difficulties. As part of an open-label pilot study of psilocybin-assisted treatment for PTLD, we explored potential for psilocybin-assisted treatment to remedy sleep-related dis...

1080 Psilocybin Elicits Non-Linear Night to Night Changes in Sleep Spectral Power

Abstract Introduction Despite evidence of an acute effect of psilocybin on sleep physiology, its enduring effects beyond the period of acute administration and active metabolism remain unexplored. Within a clinical trial of psilocybin-assisted therapy for alcohol use disorder comorbid with major depressive disorder, we monitored sleep for ten continuous nigh...

0408 Insomnia Severity Differences by Psilocybin, LSD, and DMT Use Status Among Young Adult Daily Cannabis Consumers in the Herbal Heart Study

Abstract Introduction Psychedelic use and interest in its therapeutic potential are rapidly increasing; yet its relationship with insomnia remains poorly understood. This study aims to estimate differences in insomnia severity by type of psychedelic consumed among a cohort of 18-to-35-year olds. Methods Data are from the Herbal Heart Study - Sleep Ancillary ...

Neural correlates of insight on psilocybin: a within-subjects, healthy volunteer study

Exploring new avenues: Psychedelic-assisted therapy for young people.

Rates of mental illness in young people are increasing, whereas the development of novel mental health treatments has not significantly progressed. Psychedelic-assisted therapy, using substances such as psilocybin and 3,4-methylenedioxymethamphetamine (MDMA), has shown potential in the treatment of mental illnesses in the adult population, including depressi...

Does Psilocybin Require Psychedelic Effects to Treat Depression? A4-Week, Double-Blind, Proof-of-Concept Randomized Controlled Trial

Psilocybin, the chemical component of "magic mushrooms", has been administered with psychotherapy in several randomized clinical trials (RCTs) showing large and sustained antidepressant effects. In healthy volunteers, the psychedelic effects of psilocybin have been shown to be blocked by administration of serotonin (5HT)2A receptor antagonists such as risper...

Psilocybin-Assisted Therapy in Depressive Disorders: Efficacy, Safety, and Persistence of Clinical Effects - A Narrative Review

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...

Magic mushroom compound shows promise against cocaine addiction.

Small study that prioritized Black and low-income participants yields "remarkable" results.

The magic of mushrooms: psilocybin influences behavior in the mangrove rivulus fish, Kryptolebias marmoratus.

Non-human models, including fish, are increasingly important for investigating how pharmacological agents such as hallucinogens influence behavior, physiology, and cellular processes. These models help to reveal underlying mechanisms and to support assessments of toxicological impact, efficacy, and safety. In this study, we used isogenic lineages of the amph...

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of up to Two Doses of Psilocybin for the Treatment of Major Depressive Disorder in Adults With Cancer

This is a Phase 2, single-center study to explore the efficacy, safety, and tolerability of up to two 25-mg doses of psilocybin administered at an interval of 9 to 10 weeks in patients with MDD and cancer. This two-part study will administer a fixed dose (25 mg) of psilocybin in a double-blind, randomized, placebo-controlled portion (Dosing Session 1) and su...

Induction Protocol for Psilocybin-Assisted Therapy in Treatment-Resistant Depression (TRD): A Pilot Study

The goal of this clinical trial is to test how well psilocybin-assisted therapy works in treating people with depression. The main questions this study aims to answer are: * Does psilocybin with assisted therapy help improve symptoms for people with depression? * How long do the effects of this treatment last? Participants will: * Take part in a couple of sc...

A Phase 2 Randomized Study Examining the Safety, Feasibility, and Effectiveness of Masking Psilocybin Therapy With General Anesthesia in Major Depressive Disorder

Major depressive disorder (MDD) affects millions of Americans and remains difficult to treat. Psilocybin, a psychedelic compound, has shown promise for reducing depression symptoms, but a key challenge in psychedelic research is that participants can usually tell whether they received the active drug - making it hard to conduct fully blinded studies. This st...

An Exploratory Pilot Study of Palliadelic Treatment to Reduce Psychological Distress in People With Pancreatobiliary and Other Advanced Gastrointestinal Cancers

The primary objective of this study is to evaluate the ability to recruit and retain participants, and to successfully conduct a psilocybin-based protocol, for a study of the treatment of distress related to stage IV or inoperable gastrointestinal cancers. Secondary objectives include pre/post, and longitudinal measurement of distress in intervention partici...

Human brain changes after first psilocybin use.

Psychedelics have robust effects on acute brain function and long-term behavior but whether they also cause enduring functional and anatomical brain changes is largely unknown. In an exploratory, placebo-controlled, within-subjects, electroencephalography (EEG), and magnetic resonance imaging (MRI) study in 28 healthy, entirely psychedelic-naive participants...