Journal of Psychopharmacology
August 29, 2026
Marlene L. Tai, B. Szigeti, Amanda E. Downey et al.
BACKGROUND Psilocybin, a serotonergic psychedelic found in hallucinogenic mushrooms, is metabolized to psilocin, the compound responsible for its psychoactive effects. Psilocybin has demonstrated therapeutic potential for neuropsychiatric conditions. While recent trials have primarily used orally administered synthetic psilocybin, alternative formulations and delivery methods may offer...
Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology
April 9, 2025
Ellen Bradley, Kimberly Sakai, Gisele Fernandes-Osterhold et al.
23 citations
Mood dysfunction is highly prevalent in Parkinson's disease (PD), a main predictor of functional decline, and difficult to treat-novel interventions are critically needed. Psilocybin shows early promise for treating depression and anxiety, but its potential in PD is unknown, as safety concerns have excluded people with neurodegenerative disease from previous trials. In this open-label pilot...
Psychiatry Research
March 1, 2025
Stephanie L. Haft, Amanda E. Downey, Marissa Raymond-Flesch et al.
22 citations
A lack of diverse and representative participant samples in mental health intervention research perpetuates mental health disparities. This issue has become a salient concern in studies of psychedelic-assisted psychotherapy (PAT), which is emerging as a promising mental health intervention. This systematic review evaluates the reporting, representation, and analysis of participant...
JAMA Psychiatry
March 1, 2025
Michelle Matvey, Dennis Parker Kelley, Ellen Bradley et al.
12 citations
There is unprecedented clinician, industry, and patient interest in the therapeutic development of psychedelic drugs. This is due to a combination of promising clinical trial results, positive media coverage, and the lack of novel pharmacologic treatments for psychiatric disorders in recent decades. However, the field faces a key methodological challenge: masking participants to treatment...
Psychopharmacology
August 1, 2024
Jacob S. Aday, David Horton, Gisele Fernandes-Osterhold et al.
39 citations
Psychedelic-assisted psychotherapy (PAP) has emerged as a potential treatment for a variety of mental health conditions, including substance use disorders and depression. Current models of PAP emphasize the importance of psychotherapeutic support before, during, and after ingestion of a psychedelic to maximize safety and clinical benefit. Despite this ubiquitous assumption, there has been...
Psychopharmacology
August 1, 2024
Kimberly Sakai, Ellen Bradley, Joseph A. Zamaria et al.
10 citations
Treatments with the serotonergic psychedelic psilocybin are being investigated for multiple neuropsychiatric disorders. Because many patients with these disorders use selective serotonin reuptake inhibitors (SSRIs), understanding interactions between psilocybin and SSRIs is critical for evaluating the safety, efficacy, and scalability of psilocybin-based treatments. Current knowledge about...
Psychedelic Medicine
February 28, 2024
Joshua Woolley, Amanda E. Downey, Ellen Bradley et al.
2 citations
Balancing the need for effective treatments against the potential for serious adverse events in those undergoing psilocybin therapy with a family history of BD, we argue for caution in psychedelic clinical trials but not outright exclusion of these individuals. Our risk stratification tool allows for more nuanced inclusion and exclusion criteria.
JAMA
August 31, 2023
Charles L. Raison, Gerard Sanacora, Joshua Woolley et al.
493 citations
Importance Psilocybin shows promise as a treatment for major depressive disorder (MDD). Objective To evaluate the magnitude, timing, and durability of antidepressant effects and safety of a single dose of psilocybin in patients with MDD. Design, Setting, and Participants In this phase 2 trial conducted between December 2019 and June 2022 at 11 research sites in the US, participants were...
Psychedelic Medicine
February 16, 2023
Zachary Skiles, Noa Eaton, Lisa Fredenburg et al.
49 citations
Background: An emerging controversy in psychedelic therapy regards the appropriateness or necessity of psychedelic therapists having personal experience using psychedelics themselves. Although there are a number of potential advantages and disadvantages to personal use among psychedelic therapists, no studies to date have measured their use or other aspects of their training. Materials and...
Psychopharmacology
April 1, 2022
Jacob S. Aday, Boris D. Heifets, Steven D. Pratscher et al.
214 citations
RationalePsychedelic research continues to garner significant public and scientific interest with a growing number of clinical studies examining a wide range of conditions and disorders. However, expectancy effects and effective condition masking have been raised as critical limitations to the interpretability of the research.ObjectiveIn this article, we review the many methodological...
Journal of Affective Disorders Reports
September 22, 2021
David E. Gard, Mollie Pleet, Ellen Bradley et al.
33 citations
Growing evidence suggests that psilocybin, the active ingredient in hallucinogenic mushrooms, can rapidly and durably improve symptoms of depression, leading to recent breakthrough status designation by the FDA and legalization for mental health treatment in some jurisdictions. Depression in bipolar disorder is associated with significant morbidity and has few effective treatments. However,...
Balázs Szigeti, Ellen Bradley, Joshua Woolley
preprint
On August 9th the US Food and Drug Administration’s (FDA) rejected 3,4-methylenedioxymethamphetamine assisted therapy (MDMA-AT) as a treatment for post-traumatic stress disorder (PTSD), despite seemingly positive trial results. A major reason cited was functional unmasking, which combined with enthusiasm about MDMA, raised concerns about the objectivity of these trials. Here, we define what is...
Amanda E. Downey, Ellen Bradley, Daniel Dickison et al.
preprint
Psychedelic-assisted psychotherapy is generating substantial clinical interest, yet despite growing economic scrutiny, a practical question has received surprisingly little attention: how do specific delivery decisions drive cost? Labor costs—typically the dominant cost component of psychedelic therapy delivery—depend on a tangle of interacting design choices: the number, length, and staffing...