This study is being done to identify a dosing strategy that will allow IV psilocybin to be administered to sleeping participants without awakening them. The study commenced with 1 subject receiving 2 mg IV infusion of psilocybin over 2 minutes and 2 subjects receiving 2 mg IV infusion of psilocybin over 10 minutes. Subsequently, the pre-treatment of 0.2 mg o...
This is a single-arm, open-label interventional study of psilocybin-assisted interpersonal therapy for treatment resistant depression. 20 participants will be recruited to take part in this 8-week intervention that involves 8 sessions of psychotherapy and 2 doses of psilocybin. Study Design Interventional, Single arm, open label 1\. Hypotheses: 1. It is feas...
INTRODUCTION: Prolonged grief disorder (PGD) represents a substantial public health issue, especially in oncology settings where it affects up to 30% of bereaved carers. Current best-practice treatments are lengthy, and up to 50% of participants have persistent PGD. Building on encouraging recent research with psychedelic-assisted therapies, the Psilocybin-A...
The stressors that frontline healthcare workers experienced during the COVID-19 pandemic led to widespread burnout, depression, and post-traumatic stress disorder (PTSD). Based on research showing that psychedelic-assisted therapy led to improvement in symptoms of depression in various populations, investigators conducted a randomized clinical trial to evalu...
BACKGROUND: Obsessive-compulsive disorder (OCD) is a complex condition marked by persistent distressing thoughts and repetitive behaviours. Despite its prevalence, the mechanisms behind OCD remain elusive, and current treatments are limited. This protocol outlines an investigative study for individuals with OCD, exploring the potential of psilocybin to impro...
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...
OBJECTIVE: Depression varies along a difficulty-to-treat spectrum. Patients whose illness fails to respond to at least five treatments may be considered to have severely treatment-resistant depression (TRD). The objective of this study was to document the safety and efficacy of psilocybin in patients with severe TRD. METHODS: This was a 12-week, open-label t...
To better understand the potential benefits of psychedelics in overeating disorders, Tryp Therapeutics will conduct a safety and feasibility clinical trial using TRP8802 among individuals with Binge Eating Disorder. This is a single-center phase 2a open-label study to assess the safety and feasibility of a single dose of TRP8802 in subjects with BED. Subject...
This project is an open-label randomized study looking at an 8-week Mindfulness-Based Stress Reduction (MBSR) curriculum vs. an 8-week MBSR curriculum + a group psilocybin-assisted psychotherapy intervention for frontline healthcare providers struggling with symptoms of depression and burnout associated with the SARS-CoV-2 pandemic. Following consenting and ...
The purpose of this study is to assess the impact of psilocybin on cognitive inflexibility and neural plasticity in a cohort of people with obsessive-compulsive disorder (OCD). This mechanistic study will utilise a within-subjects design, administering up to 10mg of psilocybin to participants with OCD (DSM-5 criteria) on two separate instances spaced four we...
Fibromyalgia (FM) is the prototypical nociplastic pain condition, characterized by widespread pain and issues with cognition, mood, and sleep. Currently, there are limited treatment options available that effectively treat FM symptoms. Psilocybin-assisted therapy (PAT) is an emerging combined drug-therapy intervention, but no studies to-date have investigate...
Fibromyalgia (FM) is the prototypical nociplastic pain condition, characterized by widespread pain and issues with cognition, mood, and sleep. Currently, there are limited treatment options available that effectively treat FM symptoms. Psilocybin-assisted therapy (PAT) is an emerging combined drug-therapy intervention, but no studies to-date have investigate...
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...
The purpose of this study is to determine the safety, tolerability, and feasibility of psilocybin therapy in people with Bipolar II Disorder. The primary goal of this study is to examine the safety, tolerability, and feasibility of psilocybin therapy in people with Bipolar II Disorder (BD II). Fourteen participants, ages 18 to 70 with clinically diagnosed BD...
The purpose of this study is to determine the safety and feasibility of performing psilocybin-assisted psychotherapy in patients hospitalized for treatment-resistant depression. The proposed study will assess the safety, feasibility, preliminary results and neurological aspects of psilocybin-assisted psychotherapy in the treatment of hospitalized patients wi...
Abstract Background Psilocybin, a serotonin 2A receptor agonist with psychedelic properties, shows promise as a novel treatment for alcohol use disorder (AUD). While current studies involve two dosing sessions, the effects a single dose have not been investigated. Aims To investigate the pharmacokinetics, feasibility, safety, and efficacy of single-dose psil...
ImportanceBipolar II disorder (BDII) is a debilitating condition frequently associated with difficult-to-treat depressive episodes. Psilocybin has evidence for rapid-acting antidepressant effects but has not been investigated in bipolar depression.ObjectiveTo establish the safety and efficacy of psilocybin in patients with BDII in a current depressive episod...
BackgroundPsilocybin-assisted psychotherapy (PAP) is a promising treatment option for depression, with randomized controlled trials (RCTs) providing preliminary support for its safety and efficacy. However, there is a lack of consistency across existing treatment protocols and psychotherapeutic approaches. The objective of this review is to summarize and com...
PROTOCOL SYNOPSIS Title The effect of psilocybin on Major depressive disorder (MDD) symptom severity and synaptic density - a single dose randomized, double blind, placebo-controlled phase 2b positron emission tomography study Study Code PSIPET Name of Sponsor SLSO Organisationsnr: 232100-0016 Sponsor representative: Andreas Carlborg Norra Stockholms Psykiat...
