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...
We propose a first-of-its-kind open-label clinical trial to investigate the feasibility, tolerability, and safety of administering psilocybin in autistic adults with treatment-resistant depression (TRD). In this study, 20 participants (intellectually able and fluent-speech adults) with autism and co-occurring TRD will receive around 20 hours of manualized ps...
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...
Psilocybin, the chemical component of "magic mushrooms", has been administered with psychological support in several randomized clinical trials (RCTs) showing large and sustained antidepressant effects. The purpose of this study is to determine the role of psilocybin monitors on the effects of psilocybin therapy in adults with treatment resistant depression....
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, ...
psychiatric disorders, beta-carbolines, trace amine, phosphoproteomics, social hierarchy. Scientific interest in psychedelic substances has re-emerged, offering new perspectives on the treatment of neuropsychiatric and neurological disorders.Historically, psychedelics have been associated with a wide spectrum of positive and negative effects, encompassing ri...
AIMS: The recent regulatory approval of esketamine in adults heralded the renaissance of research into psychedelic compounds. However, the relevance of this resurgence for children and adolescents remains unclear. This review examines the rationale for investigating psychedelics in pediatric psychopharmacology. METHODS: We reviewed recent literature, regulat...
BACKGROUND: Current treatments for obsessive-compulsive disorder (OCD), including serotonin reuptake inhibitors and cognitive-behavioral therapy, are often insufficient. Psilocybin, a 5HT2a agonist psychedelic, has shown promise for treating OCD, but rigorous evidence is still needed. AIMS: This randomized clinical trial evaluated safety, tolerability, and b...
Serotonergic psychedelics are re-emerging as therapeutic candidates across psychiatry, particularly for treatment-resistant depression. Their rapid and sustained antidepressant effects, alongside evidence for neuroplastic, dopaminergic, and glutamatergic modulation, have prompted interest in whether they could address depressive and negative symptoms in schi...
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...
Importance: Annual tobacco-related death estimates are 480 000 in the US and 8 million worldwide, surpassing mortality for other abused substances. Most smoking cessation interventions result in modest long-term success. Objective: To compare prolonged smoking abstinence rates in smokers receiving psilocybin plus cognitive behavioral therapy (CBT) with those...
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 ...
The primary aim of this study is to assess the safety and efficacy of psilocybin-assisted therapy in the treatment of post-traumatic stress disorder in United States military Veterans. The objective of this study is to determine the safety and efficacy of psilocybin assisted psychotherapy in the treatment of Veterans with PTSD. This study will recruit 15 Uni...
PURPOSE: The purpose of this review is to evaluate which psychedelics have the most efficacy data to support their use in the treatment of posttraumatic stress disorder (PTSD). This review also aims to assess safety data and concerns related to psychedelic therapies and identify demographic characteristics that may influence clinical outcomes. SUMMARY: A sys...
This study is assessing the efficacy and safety of NPX-5 in psilocybin-assisted psychotherapy for the treatment of adjustment disorder due to cancer diagnosis. Who is it for? This study is for people who are aged between 18 and 80 years old and suffer from anxiety after adjusting to an acutely stressful event of their cancer diagnosis. This is called adjustm...
Selective serotonin reuptake inhibitors (SSRIs) are widely prescribed for mood and anxiety disorders, the same conditions under which psychedelic-assisted therapies are gaining renewed interest. However, it remains unclear how SSRI treatment may influence sensitivity to psychedelics, particularly through the shared engagement of serotonergic pathways. Here, ...
Background: Psychedelic therapies are gaining attention as tools to alleviate anxiety and depression across various clinical populations. However, the mechanisms behind psychedelics' therapeutic efficacy and the potential differences in how patients with certain diagnoses experience their subjective effects remain unknown. One commonly suggested mediator of ...
Meaning is a primary existential concern in those with advanced illnesses and functions as an important coping mechanism. Loss of meaning contributes to existential distress, and, in particular, may manifest as demoralization, a syndrome of poor coping that is associated with negative outcomes. Psychedelics are unique psychoactive compounds that, among other...
