About 30-50% of patients with advanced illness experience depression, anxiety, or decreased sense of purpose and autonomy. Together, these are called psychological distress. Treatment options such as medication and therapy are available; however, they do not always work and can be time-consuming and expensive. We need treatments that work well, quickly, and ...
The goal of this multi-centre phase I/II open-label, single-arm study is to determine the safety, feasibility, therapeutic dose, and preliminary efficacy of psilocybin microdosing to treat psychological distress among patients with advanced illness. Forty patients will receive psilocybin drug product (1-3mg per day, Mon-Fri) for 4 weeks to be administered vi...
Obsessive-compulsive disorder (OCD) is a chronic neuropsychiatric condition characterized by intrusive thoughts and repetitive behaviors that cause distress and functional impairment worldwide. Although selective serotonin reuptake inhibitors and cognitive behavioral therapy are first-line treatments, a considerable proportion of patients show an insufficien...
There is growing interest in psychedelic compounds such as psilocybin, 3,4-metheylenedioxymethamphetamine (MDMA), lysergic acid diethylamide (LSD), and dimethyltryptamine (DMT) given emerging research on potential uses as treatments for a variety of health conditions. The United States Food and Drug Administration (FDA) has granted multiple “Breakthrough The...
Based on its in vitro profile and preliminary evidence, 4-bromo-2,5-dimethoxyphenethylamine (2C-B) may have psychoactive properties that are similar to 3,4-methylenedioxymethamphetamine (MDMA) and psilocybin, which are investigated for the treatment of posttraumatic stress disorder and depressive disorders. We compared acute effects of 2C-B (10, 20, and 30 m...
The purpose of this study is to understand whether people with Parkinson's Disease and depression have improvement in their symptoms after psilocybin therapy. This is a randomized controlled trial of oral psilocybin therapy for depression in people with Parkinson's disease (PD). The primary goal is to examine efficacy of psilocybin therapy in this patient po...
To learn if psilocybin can help to prevent or decrease the severity of chemotherapy-induced peripheral neuropathy (CIPN) in patients who are receiving chemotherapy for the treatment of breast, colorectal, and In this study, psilocybin is being compared to standard supportive care and to a placebo. Primary Objective 1\. To assess the efficacy of psilocybin in...
The PEARL-C1 trial is a phase II open-label trial. Participants will receive a single high-dose (25 mg) of psilocybin in the context of Psilocybin-assisted Existential, Attachment and RelationaL (PEARL) therapy. Caregivers of patients with advanced cancer often experience high levels of distress but there is currently little evidence-based guidance on how to...
The PEARL Pilot is a phase II open-label trial. Participants will receive a single high-dose (25 mg) of psilocybin in the context of Psilocybin-assisted Existential, Attachment and RelationaL (PEARL) therapy. Individuals with advanced cancer often experience high levels of distress due to physical suffering, difficult treatment decisions, social isolation, a...
Treatment-resistant depression (TRD) remains a major clinical challenge and is typically defined as the persistence of depressive symptoms despite at least two adequate antidepressant trials. Individuals with TRD experience substantial morbidity, impaired functioning, and elevated suicide risk, highlighting the need for therapeutic strategies beyond incremen...
Informed by a community engagement process, we have developed a pragmatic, open-label, hybrid feasibility-implementation study of Group Psilocybin-Assisted Therapy (GPAT) for post-traumatic stress disorder (PTSD). As psychedelic-assisted therapies begin to enter the broader mental health arena, engaging communities in the design of research and care models i...
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...
BACKGROUND AND OBJECTIVE: Dextromethorphan (DXM), widely used as an over-the-counter antitussive in the United States, exhibits psychoactive effects at supratherapeutic levels that overlap with those of classic and dissociative psychedelics. Reported psychoactive effects have generated interest in DXM as a potential therapeutic agent for treatment-resistant ...
This scoping review aims to comprehensively map and synthesize the breadth of evidence from original research on the relationship between psilocybin and health, spanning clinical trials, epidemiological surveys, mechanistic experiments, and cross-sectional attitudinal studies. The review uses 145 references and builds its evidence map from 216 original studi...
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...
Recent studies have shown promising results for psychedelics in the treatment of psychiatric disorders. Both in clinical and recreational settings, contextual elements, such as music, can influence the experience of users and may be linked to positive outcomes. This systematic review identifies how music is being selected and used in psychedelisc-assisted ps...
Abstract The Czech Republic, like many European countries, continues to face significant challenges in treating substance use disorders (SUDs), with high relapse rates and complex comorbidities often linked to trauma and mental illness. Psychedelic-assisted psychotherapy (PAP) has re-emerged internationally as a promising therapeutic modality, although avail...
OBJECTIVES: Attention deficit and hyperactivity disorder (ADHD) is a prevalent neuropsychiatric disorder (Drechsler et al., 2020). Recently, psychedelics have become of interest regarding developing treatment options for ADHD. The aim of this systematic review is to find all studies from the APA PsychInfo and MEDLINE databases, where psychedelics have been u...
To assess the safety and feasibility of administering physiotherapy following psilocybin in patients with refractory motor Functional Neurological Disorder (FND), and to determine a treatment regimen that optimises symptom improvement.
