Ketamine and its enantiomers, esketamine and arketamine, have emerged as promising treatments for treatment-resistant depression (TRD). This cross-sectional study evaluates the regulatory alignment of 40 clinical trials listed on ClinicalTrials.gov, focusing on the methodological challenges. The study highlights methodological inconsistencies, particularly a...
Objective To evaluate psilocybin's efficacy in reducing depressive and anxiety symptoms in cancer patients based on randomized controlled trials (RCTs). Methods This systematic review and network meta-analysis (NMA) followed PRISMA and Cochrane Handbook guidelines. PubMed, Embase and Cochrane Library data up to July 2024 were analyzed. Two RCTs met the inclu...
RationalePsilocybin is a potentially paradigm-shifting depression intervention. We conducted a systematic review and meta-analysis of psilocybin-for-depression randomized controlled trials (RCTs).ObjectivesSystematically assess harm reporting, risk of bias, action mechanism specification, and incremental therapeutic effect sizes in the psilocybin-for-depress...
ObjectivesPsychological and existential distress is prevalent among patients with life-threatening cancer, significantly impacting their quality of life. Psilocybin-assisted therapy has shown promise in alleviating these symptoms. This systematic review aims to synthesize the evidence on the efficacy and safety of psilocybin in reducing cancer-related distre...
This systematic review explores the comparative efficacy and functional outcomes of psychedelic-assisted therapies in the management of treatment-resistant depression (TRD). Following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, a comprehensive literature search was conducted across PubMed, Scopus, and Web of Sc...
Regulatory compliance is crucial in the clinical development of psychedelic substances, including psilocybin. This study aimed to examine the alignment of clinical trial protocols for psilocybin in the treatment of major depressive disorder (MDD) and treatment-resistant depression (TRD) with established regulatory requirements.A cross-sectional investigation...
Background Patients with Major Depressive Disorder (MDD) have more dysfunctional attitudes and pessimism than healthy individuals and these biases are correlated with depression severity. Psilocybin has demonstrated sustained remission in MDD. Methods Secondary analysis of a two-arm, randomized controlled trial ( ClinicalTrials.gov Identifier: NCT03429075 ) ...
New methods that capture the public's perception of controversial topics may be valuable. This study investigates public sentiments towards psychedelics and other substances through analyzes of Reddit discussions, using Google’s cloud-based Natural Language Processing (NLP) infrastructure. Our findings indicate that illicit substances such as heroin and meth...
New methods that capture the public's perception of controversial topics may be valuable. This study investigates public sentiments towards psychedelics and other substances through analyzes of Reddit discussions, using Google’s cloud-based Natural Language Processing (NLP) infrastructure. Our findings indicate that illicit substances such as heroin and meth...
ObjectivePsychedelics are gaining renewed attention, especially through the practice of microdosing, where low doses are taken regularly. Microdosing lysergic acid diethylamide (LSD) and psilocybin is used by both healthy individuals and those with mental health conditions to improve daily functioning, reduce anxiety, and enhance mood and cognition. However,...
Background and aimsThis is the first systematic review of the extant literature on all major psychedelic-assisted treatment for alcohol use disorder (AUD), tobacco use disorder (TUD) and other substance use disorders (SUD). We aimed to summarise the evidence for efficacy of psychedelic-assisted treatment for AUD, TUD, and SUD; to evaluate its quality; and to...
RationalePsilocybin shows promise for treating neuropsychiatric disorders. However, insight into its acute effects on cognition is lacking. Given the significant role of executive functions in daily life and treatment efficacy, it is crucial to evaluate how psilocybin influences these cognitive domains.ObjectivesThis meta-analysis aims to quantify the acute ...
Selecting the optimal dose of psilocybin for treating Major Depressive Disorder (MDD) and Treatment-Resistant Depression (TRD) is crucial for clinical development and regulatory approval. This meta-analysis evaluates psilocybin's efficacy and safety in treating MDD to determine the optimal dose and timing for clinical trials. A systematic review and Dose-Res...
IntroductionPsychedelic-Assisted Therapy (PAT) is gaining traction as a novel approach to addressing the psychological and existential distress experienced by patients.ObjectivesThis systematic review aimed to investigate the impact of PAT on spirituality, mystical experiences, and spiritual well-being (SpWB) in patients with life-threatening, incurable, or ...
Preliminary research shows the psychedelic psilocybin to be a promising potential treatment for psychiatric illnesses. Recent U.S. government legislation and policy indicate that access to psilocybin, which remains illegal on the federal level despite increasing efforts to decriminalize it at the state and local levels, will be expanded to enable further res...
Serotonergic psychedelics induce altered states of consciousness and have shown potential for treating a variety of neuropsychiatric disorders, including depression and addiction. Yet their modes of action are not fully understood. Here, we provide a novel, synergistic understanding of psychedelics arising from systematic reviews and meta-analyses of three h...
ImportanceA clear and comprehensive understanding of risks associated with psychedelic-assisted therapy is necessary as investigators extend its application to new populations and indications.ObjectiveTo assess adverse events (AEs) associated with classic psychedelics, particularly serious AEs (SAEs) and nonserious AEs (NSAEs) requiring medical or psychiatri...
BackgroundPeripheral levels of brain-derived neurotrophic factor (BDNF) are often used as a biomarker for the rapid plasticity-promoting effects of ketamine, psychedelics, and other psychoplastogens in humans. However, studies analyzing peripheral BDNF after psychoplastogen exposure show mixed results. In this meta-analysis, we aimed to test whether the rapi...
Psilocybin, the natural hallucinogen from Psilocybe (magic) mushrooms, is a highly promising drug candidate for the treatment of depression and several other mental health conditions. Biosynthesis of psilocybin from the amino acid l-tryptophan involves four strictly sequential modifications. The third of these, ATP-dependent phosphorylation of the intermedia...
Abstract The Psilocybe cubensis SAM-dependent methyltransferase, PsiM, catalyzes the last step in the biosynthesis of psilocybin. Likely evolved from monomethylating RNA methyltransferases, PsiM acquired a key amino acid exchange in the secondary sphere of the active site, M247 N, which is responsible for its capacity to dimethylate. Two variants, PsiM N247M...
