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.
A key distinction among clinical trials on psilocybin treatments, for example, those targeting depression, has been whether the psilocybin dosing session is combined with bona fide psychotherapy or with what is referred to as “psychological support” (1-3). The most developed model of psychological support is the Compass Psychological Support Model (CPSM; 1)....
Efficacy, Safety, and Tolerability of two administrations of COMP360 in participants with treatment-resistant depression (TRD) This is a phase III, international, multi-centre, randomised, parallel group, fixed repeat dose, double-blind, controlled study. The study population will include participants aged ≥18 years with TRD. Overall, 568 participants are to...
Dear Editor, In view of ongoing global research on mental health, especially Major Depressive Disorder, we would like to draw attention to a psychedelic substance, Psilocybin, which has been emerging as a viable treatment option for MDD. Psilocybin is a psychedelic compound derived from certain mushrooms that acts on Serotonergic receptors (primarily 5HT-2A)...
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...
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...
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...
Safety, Tolerability, pharmacokinetics and efficacy of a single administration of COMP360 in participants with recurrent Major Depressive Disorder. This is a phase II, multi-centre, randomised, double-blind, controlled study. The study population will include participants aged ≥18 years with recurrent Major Depressive Disorder (MDD) with up to four prior tre...
The Safety and Tolerability of COMP360 in Participants with Post-traumatic Stress Disorder The Safety and Tolerability of COMP360 administered under supportive conditions in participants with Post-traumatic Stress Disorder
BACKGROUND: Psychedelic treatment is a rapidly emerging therapeutic approach for a host of chronic, difficult to treat psychiatric disorders, including anorexia nervosa (AN). Trauma and its sequelae, such as dissociation, often contribute to comorbidity and treatment refractoriness. AIMS: In this report, we describe the therapeutic emergence of previously di...
The largest randomized study of psilocybin to date demonstrated the efficacy of COMP360 25 mg (Compass Pathways' investigational proprietary pharmaceutical-grade synthesized psilocybin formulation) in participants with treatment-resistant depression (COMP001), compared with 10 mg and 1 mg doses. Here, we report findings from COMP004, a 52-week observational ...
The psychedelic experience can be challenging. There is a need for a structured framework for providing psychological support to individuals with mental health conditions receiving investigational psilocybin treatment. The primary benefit of such a framework is to support a safe and meaningful psilocybin experience. It also enables future research on the fac...
Efficacy and Safety of COMP360 Psilocybin therapy in Anorexia Nervosa: a Proof-of-concept Study This study aims to explore the efficacy and safety of COMP360 25 mg as compared to COMP360 1 mg (control condition) administered with psychological support in participants with Anorexia Nervosa
This article traces the trajectories of psilocybin and ayahuasca in the context of the psychedelic renaissance. The bibliometric analysis reveals that academic publications on psilocybin fall primarily into the medical and scientific areas, whereas those devoted to ayahuasca derive mainly from humanities and social sciences. Second, the article argues that p...
Matt Butler has nothing to declare. Sanjay Cheema: Received a research fellowship sponsored by Abbott. Giorgio Lambru: Co-chair of the Medical Advisory Board of the Trigeminal neuralgia Association (TNA) UK; received personal fees from Abbvie, Teva, Novartis, Eli Lilly, Lundbeck; participated in clinical trials as principal investigator for Novartis, Eli Lil...
The Safety and Efficacy of Psilocybin as an Adjunctive Therapy in Participants with Treatment-Resistant Depression A recent open label study of the effects of psilocybin in participants with treatment-resistant depression (TRD) showed rapid significant decrease of depressive symptoms after treatment with psilocybin coupled with psychological support. Over 40...
The Safety and Efficacy of Psilocybin in Participants with Treatment Resistant Depression The Safety and Efficacy of Psilocybin in Participants with Treatment Resistant Depression - a dose-ranging study
Background: Therapeutic administration of psychedelic drugs has shown significant potential in historical accounts and in recent clinical trials in the treatment of depression and other mood disorders. A recent randomized double-blind phase-IIb study demonstrated the safety and efficacy of COMP360, COMPASS Pathways’ proprietary synthetic formulation of psilo...
Background: Therapeutic administration of psychedelic drugs has shown significant potential in historical accounts and in recent clinical trials in the treatment of depression and other mood disorders. A recent randomized double-blind phase-IIb study demonstrated the safety and efficacy of COMP360, COMPASS Pathways’ proprietary synthetic formulation of psilo...
The primary objective of this study is to assess the long-term efficacy of psilocybin with respect to use of new antidepressant treatment, hospitalisations for depression, suicidality, and depressive severity rated using the Montgomery and Asberg Depression Rating Scale (MADRS) over a total of 52 weeks (compared across the 1 mg, 10 mg and 25 mg psilocybin gr...
