This systematic review and meta-analysis synthesized data from 13 clinical trials (n=606) evaluating psilocybin-assisted psychotherapy for major depressive disorder and treatment-resistant depression. Despite early enthusiasm, the pooled standardized mean difference (-0.79, 95% confidence interval: -3.98 to 2.40, p=0.63) revealed no statistically significant...
Psilocybin-assisted therapy shows promise for depression, though current evidence relies on Phase 2 trials with notable methodological limitations. We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) evaluating psilocybin-assisted therapy for major or treatment-resistant depression up to February 2024. We evaluated depre...
Prolonged grief disorder (PGD) affects approximately 10% of bereaved individuals and is now formally recognized in both the DSM-5-TR and ICD-11. Despite its prevalence, PGD often responds poorly to traditional therapeutic approaches. This manuscript outlines the protocol for an early-stage open-label feasibility trial investigating the use of psilocybin, a p...
BACKGROUND: Major depression is a prevalent condition among patients with life-threatening illnesses, such as cancer, and recent findings suggest that psilocybin may hold promising treatment potential. Contemporary trials of psilocybin generally employ a model that includes psychotherapeutic support consisting of preparation and integration sessions surround...
BACKGROUND AND AIMS: Australia recently down-scheduled and authorised psychedelic-assisted therapies, including psilocybin, for certain mental health conditions. Evidence is emerging for potential application in substance use disorder treatment. However, regulatory developments have outpaced implementation readiness. While service leaders and clinicians are ...
Background/Objectives: Psilocybin has re-emerged as a promising intervention for neuropsychiatric disorders including major depressive disorder, treatment-resistant depression, anxiety associated with life-threatening illness, obsessive compulsive disorder, and substance use disorders. However, conventional randomized controlled trials (RCTs)-the current gol...
Psychedelic experiences are frequently described as producing a “psychological reset,”characterized by reduced rigidity of thought and disruption of maladaptive cognitive pat-terns. Existing models such as REBUS and the entropic brain hypothesis explain acutedestabilization but do not fully account for post-experience reconstruction. This paper pro-poses a t...
While the limitations of existing treatment options have spurred investigations into the applicability of psychedelic therapies for chronic and treatment-resistant psychological disorders, there remain significant unresolved issues pertaining to how these treatments should be regulated and the implementation of an ethical framework for their widespread deliv...
RATIONALE: The nature and role of the psychological support provided in psychedelic-assisted treatments for psychiatric disorders are currently the object of debate. How this support is conceptualized-as a vector for therapeutic change or framework for risk minimization-has far-reaching consequences in terms of how these treatments should be regulated, deliv...
Depression and psychological distress are highly prevalent among patients with cancer and are associated with impaired quality of life, reduced treatment adherence, and poorer clinical outcomes. Standard pharmacological and psychosocial interventions often demonstrate limited efficacy or delayed onset of action in oncological and palliative settings. Psilocy...
Importance: Psilocybin shows promise in treating depression, although limitations of previous research warrant further research. Objective: To investigate the efficacy and safety of oral psilocybin, 25 mg, with adjunct psychotherapy in treatment-resistant depression (TRD). Design, Setting, and Participants: This was a 2-center, triple-blinded (investigator, ...
The purpose of the present study is to evaluate the feasibility, initial signals of efficacy, and potential mechanisms of action of "microdoses" of psilocybin (i.e., low doses of psilocybin that are not believed to produce mystical-type, transcendent, hallucinogenic, or other overtly salient subjective effects that limit functionality) in the treatment of mo...
The primary objective of this study is to investigate the safety, feasibility, and tolerability of psilocybin treatment in individuals with functional impairment due to psychiatric symptoms. The secondary objective of this study is to determine whether individuals with functional impairments due to psychiatric symptoms will experience statistically significa...
Abstract Background and Aims Psilocybin is a psychedelic compound that may hold promise for a wide range of human health conditions, yet the identification of therapeutic processes and mechanisms of action remains exploratory. We conducted a scoping review of pre-clinical behavioural investigations of psilocybin in non-human animals to identify behavioural e...
The goal of this clinical trial is to learn if psilocybin, given with psychological support, is safe and helps treat anorexia nervosa in young adults. Anorexia nervosa is a serious eating disorder that currently has no approved medicine. Psilocybin is a psychedelic substance that may help the brain form new connections, which could make it easier for people ...
INTRODUCTION: Psychedelic-assisted therapy shows promise for treating various mental health conditions; however, its reliance on intensive psychological preparation limits its broader application. Digital health interventions have the potential to address this limitation by providing structured, accessible and scalable preparation solutions. This randomised ...
Background: Major depressive disorder (MDD) is a highly prevalent and disabling psychiatric condition associated with substantial clinical, social, and economic burden [1,2]. Despite the availability of conventional antidepressants, their limited effectiveness, delayed onset of action, and high relapse rates have renewed interest in innovative therapeutic ap...
Abstract IMPORTANCE Microdosing psilocybin may be a novel treatment for major depressive disorder (MDD). OBJECTIVE Assessing the antidepressant effects and safety of repeated low doses of psilocybin in participants diagnosed with MDD. DESIGN This was a Phase II, randomized, double-blind, placebo-controlled clinical trial. SETTING The trial was conducted from...
Abstract Background and Purpose Music plays a central role in psychedelic-assisted therapy, yet few methodologies exist to create and assess therapeutic playlists. This study aimed to illustrate a methodology for developing and evaluating a music playlist for a clinical psilocybin trial using an integrative framework grounded in theory, intentionality, and m...
