The primary aim is to determine the feasibility of enrolling and 15 women with chronic pelvic pain (CPP) that have failed one conventional for CPP to obtain preliminary safety data on a single administration of a moderate dose of pharmaceutical grade psilocybin (25 mg) in combination with psychotherapy sessions (two pre-dose preparatory and three post-dose i...
Chronic pain and mood disorders co-occur, exacerbate one another and share neurobiological mechanisms, but whether a single intervention could promptly alleviate both conditions remains unclear. Here, in two chronic pain models, we show that a single dose of psilocybin induces a rapid and sustained reversal of both mechanical allodynia and anxiodepression-li...
Serotonergic psychedelics have shown promise in clinical trials for treating an array of mental health disorders, including depression, anxiety, and post-traumatic stress disorder. Despite these findings, our understanding of how these drugs mechanistically exert their therapeutic effects remains incomplete. While researchers have regularly employed rodent p...
Major depressive disorder (MDD) is a complex and debilitating condition affecting approximately 280 million people worldwide. Its heterogeneous nature makes it difficult to establish clinical treatment guidelines that address individual differences in treatment response. As a result, many individuals experience treatment-resistant depression (TRD) failing to...
Anorexia nervosa (AN) is an eating disorder characterized by compulsive eating restrictions and cognitive inflexibility, which is linked to dysregulation within the cortico-striatal-thalamo cortical (CSTC) circuitry. Dysfunction within the dorsolateral prefrontal cortex and dorsal striatum has been implicated in habitual decision making and impaired cognitiv...
Introduction: Recently, there has been a significant increase in interest in the use of psychedelics for various psychiatric conditions. Psilocybin is receiving particular attention as a psychoactive substance with significant therapeutic potential. Recent research focuses on its possible benefits in the treatment of major depressive disorders (MDD) and anor...
Psychedelics are undergoing a clinical research renaissance, with compounds such as psilocybin advancing to Phase 3 trials for treatment-resistant depression and receiving fast-track or breakthrough designations from regulatory agencies. Despite this progress, the field lacks standardized terminology to guide clinical development, dosing, safety monitoring, ...
BACKGROUND: The consumption of dried fruiting bodies of Psilocybe cubensis can be traced over centuries, guided by Mesoamerican curanderas, Western medical practitioners, and fungal enthusiasts, all seeking mental wellbeing. There is a notable resurgence in interest both in the fungal biomass and psilocybin, the psychoactive tryptamine, despite the global re...
Treatment resistant depression (TRD) is frequently encountered in clinical practice. The lack of response of the condition to conventional medications and augmentation strategies has spawned the search for novel treatment approaches. Psychedelic medications used in conjunction with intensive psychotherapy, so-called psychedelic-assisted psychotherapy (PAP), ...
Psilocybin, a compound found in Psilocybe mushrooms, is emerging as a promising treatment for neurodegenerative and psychiatric disorders, including major depressive disorder. Its potential therapeutic effects stem from promoting neuroprotection, neurogenesis, and neuroplasticity, key factors in brain health. Psilocybin could help combat mild neurodegenerati...
Depression, a common mental disorder, affects people at different stages of life.Classic antidepressant treatment is generally effective, however, it is prolonged.Nonetheless, numerous patients who undergo various classic antidepressant therapies still suffer from depression.Therefore, the search for novel medications is essential.In this review, we explore ...
This viewpoint reconceptualizes mysticism and fundamentalism as brain network disorders, with psychedelics like psilocybin, lysergic acid diethylamide, and N,N-dimethyltryptamine offering potential to modulate these states. By disrupting rigid neural patterns, psychedelics may foster cognitive flexibility, challenge inflexible belief systems, and offer thera...
BACKGROUND: People with HIV (PWH) are disproportionately affected by cigarette use, with a 40 - 70% prevalence rate. Although many express a strong interest in quitting, many PWH who smoke experience lower cessation rates with traditional treatments, in part due to their comorbid anxiety and depressive symptoms. Psilocybin, a classic psychedelic referred to ...
The purpose of the study is to assess the safety and acceptability of up to two sequential administrations of 25 mg psilocybin with additional therapeutic support in decreasing suicidality in patients with Bipolar Disorder (BD II) depression. This study aims to determine whether psilocybin paired with psychotherapy is a safe, feasible, and acceptable treatme...
The therapeutic potential of psychedelic substances, particularly psilocybin, for treatment-resistant depression (TRD) has garnered considerable attention. However, the necessity of subjective psychedelic experiences for therapeutic efficacy remains unclear, creating a critical gap in the field. To determine whether subjective psychedelic experiences induced...
Recent advancements in the study of psilocybin and its active metabolite psilocin have highlighted their unique psychedelic properties and potential therapeutic applications, particularly in the rapid and sustained treatment of depression. However, the potent acute psychedelic effects of psilocybin necessitate a deeper understanding of the neural mechanisms ...
The phenomenology of psychedelic experiences has been a long-standing point of interest to researchers. However, internal experience has been relatively relegated, with much work done on the clinical outcomes of psychedelic therapies. Our reflexive thematic analysis revealed that structurally, people on fora write about their experiences sequentially, consid...
MLS101 is being developed as a low dose psilocybin, that can be administered to treat neurological and psychiatric conditions. The purpose of this clinical trial is to assess how safe and tolerated MLS101 is; to see how MLS101 is distributed and cleared by the body (pharmacokinetics); and to assess the psychedelic effects of MLS101 in healthy, adult particip...
