6 research outputs found

    The development of psilocybin therapy for treatment-resistant depression: an update

    Get PDF
    Psilocybin is a classic psychedelic drug that has attracted increasing research interest over the past 10 years as a possible treatment for mood, anxiety and related conditions. Initial phase 2 clinical trials of psilocybin given alongside psychological support for major depression and treatment-resistant depression (TRD) demonstrated encouraging signs of basic safety, further confirmed by a large study in groups of healthy volunteers. The first international multi-centre randomised controlled trial was published in 2022, with signs of efficacy for the 25 mg dose condition in people with TRD when compared with an active placebo. Phase 3 trials in TRD are scheduled to start in 2023. Early evidence suggests that single doses of psilocybin given with psychological support induce rapid improvement in depressive symptoms that endure for some weeks. We therefore provide a timely update to psychiatrists on what psilocybin therapy is, what it is not, and the current state of the evidence-base

    Pharmacological treatment trials of agitation in Alzheimer's disease:A systematic review of ClinicalTrials.gov registered trials

    Get PDF
    INTRODUCTION: There is increasing emphasis on the importance of optimizing and standardizing clinical trials of agitation in Alzheimer's disease (AD), but the risks of bias arising from published trials and the number and design of unpublished studies are poorly understood. METHODS: Using the ClinicalTrials.gov database, we systematically reviewed all registered investigational clinical trials for agitation in AD to describe the landscape of agitation drug treatment trials and to assess their quality and generalizability. RESULTS: We included 52 clinical studies registered over the past 25 years. Within published randomized controlled trials (RCTs), there was a high rate of participant dropout, poor reporting of randomization procedures, and inconsistent definitions of the sample included for analysis. There was also evidence of publication and funder bias. DISCUSSION: We discuss factors that limit the internal and external validity of published RCTs and make additional recommendations for the conduct and reporting of future clinical trials of agitation in AD
    corecore