This is a double-blind, randomized, placebo-controlled Phase 2 mechanistic clinical trial designed to evaluate the therapeutic neural mechanisms of psilocybin in patients with alcohol use disorder (AUD), and to determine whether further studies are warranted to study the relationship of any such effects to clinical improvement in AUD symptoms. The primary ai...
Efficacy, Safety, and Tolerability of a single administration of COMP360 in participants with treatment-resistant depression (TRD) This is a phase III, international, multi-centre, randomised, parallel group, fixed single-dose, double-blind, placebo-controlled study. The study population will include participants aged ≥18 years with TRD. Overall, 255 partici...
Australia's reclassification of psilocybin as a Schedule 8 substance for treatment-resistant depression represents a significant shift in psychiatric policy. While this regulatory change positions Australia as a global leader in psychedelic medicine, its implementation has revealed substantial challenges. This article critically examines the regulatory, ethi...
Introduction:Psilocybin, a classical psychedelic, has shown to produce persistent antidepressant effects, including in patients with treatment-resistant depression. In clinical practice, it is common to coprescribe benzodiazepines (BZDs) alongside antidepressants. However, our preliminary study indicated that preadministration of lorazepam diminished the ant...
Introduction: Major depressive disorder (MDD) affects over 21 million adults in the U.S (NIMH, 2023) and remains a significant public health challenge. Despite the effectiveness of traditional medications, 30% of patients remains resistant. Little is known about the beliefs individuals hold regarding novel treatments, such as psilocybin and the motivations b...
BACKGROUND: Obsessive-compulsive disorder (OCD) is a debilitating mental disorder commonly treated with selective serotonin reuptake inhibitors, atypical antipsychotic augmentation and cognitive-behavioural therapy. However, up to 60% of people with OCD do not respond to these treatments. Therefore, a novel intervention, psilocybin-assisted psychotherapy (PA...
Objective: To compare acceptability and effectiveness of psilocybin, ketamine and commonly prescribed antidepressants in the management of Major Depressive Disorder (MDD). Methods: This is a systematic review with network meta-analysis. The survey was conducted between January and June 2023, employing MEDLINE, PsyINFO, Embase, Web of Science and ClinicalTria...
Introduction: The subjective effects of psilocybin on obsessive-compulsive disorder (OCD) are under-explored. Therefore, we conducted a qualitative study of participant experiences from the first randomized placebo-controlled trial of single-dose psilocybin combined with unstructured and non-directive support for individuals with treatment-refractory OCD. Ou...
The global demographic shift toward aging populations has intensified the need for innovative therapeutic interventions targeting late-life mental health conditions, notably depression, loneliness, and existential distress. Traditional pharmacological treatments often exhibit limited efficacy and poor tolerability in older patients, primarily due to age-rela...
PURPOSE/BACKGROUND: The therapeutic effects of psilocybin treatment are thought to be influenced by the subjective dose-dependent psychedelic experience, as well as the individual participant's mindset and the treatment environment. However, the relative contribution of an individual's pretreatment clinical characteristics and their subjective psychedelic ex...
Approximately 20% of young people experience self-harm behaviour in their lives. Self-harm can occur across different mental health disorders, and lead to negative outcomes and risk of suicide. Current treatments are long, costly and do not suit all young people, making it essential to research alternative treatments. Therapy combined with psychedelic drugs ...
The purpose of this research is to study the safety and effects of single-dose psilocybin 25mg versus an active placebo (single dose niacin 100mg) in the treatment of anxiety, depression, and existential distress (i.e., loss of meaning and hope; fear of death) in advanced cancer (i.e., stage 3 or 4). Study medications will be administered in conjunction with...
Introduction Mental health disorders, including depression, anxiety, and post-traumatic stress disorder (PTSD), remain a significant global health concern, requiring novel therapeutic approaches. Psilocybin, a psychedelic compound found in certain mushrooms, has shown potential in modulating neuroplasticity, a critical process for cognitive flexibility and m...
Background: Post-traumatic stress disorder (PTSD) is a debilitating condition leading to significant personal and societal burden. Standard treatments frequently demonstrate limited efficacy, leading to persistent symptoms and high dropout rates. Psilocybin has shown promise in treating depression, a condition that is often comorbid with PTSD. We aimed to ex...
Background: Psilocybin-assisted psychotherapy (PAP) may be an effective intervention for a range of mental disorders. However, there appears to be a relative lack of qualitative evidence to complement emerging quantitative findings. To our knowledge, no reviews have systematically mapped the literature on qualitative studies on PAP for the treatment of menta...
Psilocybin, a naturally occurring psychedelic compound, has received attention as a novel therapeutic option for major depressive disorder (MDD), particularly in cases where traditional treatments prove ineffective. The study aims to evaluate psilocybin's therapeutic potential by examining its efficacy, safety, and mechanisms of action as well as addressing ...
BACKGROUND: Cognitive difficulties within treatment-resistant unipolar and bipolar depression (TRD; TRBD) often do not improve with conventional pharmacotherapies. Psilocybin-assisted psychotherapy (PAP) has shown promise as a novel intervention for TRD; however, few studies have assessed its effects on cognition in this population. METHODS: This retrospecti...
