18 papers in the library · 457 citations · publishing 2018-2026
JAMA Psychiatry October 21, 2026 Ellen Bradley, Parker Kelley, Balázs Szigeti et al.
This nonrandomized clinical trial assesses associations between psilocybin therapy and changes in systemic markers of inflammation and mitochondrial stress in people with Parkinson disease and mood dysfunction.
Journal of Psychopharmacology August 29, 2026 Marlene Tai, Balázs 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...
The Lancet Psychiatry May 1, 2026 Joseph J. Taylor, Balázs Szigeti, Noah D. Silverberg et al.
Placebo effects are among the greatest paradoxes in medical research. Although more data on placebos are available from placebo-controlled trials than on any treatment in medicine, there has been comparatively little deep interrogation of issues related to their measurement, appraisal, and interpretation. Most of the work that has been done, including that in psychiatry, is narrowly focused on...
JAMA Psychiatry March 18, 2026 Zachary J. Williams, Hannah Barnett, Balázs Szigeti 10 citations
Importance: Psychedelic-assisted therapy (PAT) trials have high levels of functional unblinding, which biases results when comparing PAT with blinded interventions. Because PAT is effectively always open label, treatment results should be compared with those of open-label traditional antidepressants (TADs), so potential benefits associated with patients knowing their treatment is equal between...
July 7, 2025 Balázs Szigeti preprint
Background: Individuals with bipolar II disorder (BD-II) and depression face limited treatment options and are often excluded from psilocybin therapy trials due to theoretical concerns of precipitating mania or psychosis. Although psilocybin has demonstrated antidepressant effects when combined with psychotherapy, adverse event reporting is inconsistent, and restrictive eligibility criteria...
Nature Medicine June 3, 2025 Chloé Pronovost-Morgan, Kyle T. Greenway, Leor Roseman et al. 26 citations
Psychedelic substances exhibit complex interactions with the 'set and setting' of use, that is, the mental state of the user and the environment in which a psychedelic experience takes place. Despite these contextual variables' known importance, psychedelic research has lacked methodological rigor in reporting extra-pharmacological factors. This study aimed to generate consensus-based...
Alcohol and Alcoholism May 14, 2025 Hannah Thurgur, Ben Sessa, Laurie Higbed et al. 3 citations
Safety and tolerability data from the first open-label feasibility study of 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy for alcohol use disorder was recently published. This paper presents a Bayesian analysis of the impact of MDMA-assisted psychotherapy on treatment success, defined as 2-level reduction in the World Health Organization (WHO) drinking risk at the 3 months...
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...
Psychological Medicine June 1, 2024 Balázs Szigeti, Brandon Weiss, Fernando E. Rosas et al. 74 citations
To investigate the association between pre-trial expectancy, suggestibility, and response to treatment in a trial of escitalopram and investigational drug, COMP360, psilocybin, in the treatment of major depressive disorder (ClinicalTrials.gov registration: NCT03429075). We used data (n = 55) from our recent double-blind, parallel-group, randomized head-to-head comparison trial of escitalopram...
Biological Psychiatry: Cognitive Neuroscience and Neuroimaging May 1, 2024 Balázs Szigeti, Boris D. Heifets 62 citations
Clinical trials of psychedelic compounds like psilocybin, lysergic acid diethylamide (LSD), and N,N-dimethyltrptamine (DMT) have forced a reconsideration of how nondrug factors, such as participant expectations, are measured and controlled in mental health research. As doses of these profoundly psychoactive substances increase, so does the difficulty in concealing the treatment condition in the...
Scientific Reports July 26, 2023 Balázs Szigeti, David Nutt, Robin Carhart-Harris et al. 33 citations
In medical trials, 'blinding' ensures the equal distribution of expectancy effects between treatment arms in theory; however, blinding often fails in practice. We use computational modelling to show how weak blinding, combined with positive treatment expectancy, can lead to an uneven distribution of expectancy effects. We call this 'activated expectancy bias' (AEB) and show that AEB can inflate...
British Journal of Clinical Pharmacology July 17, 2023 Balázs Szigeti, Lawrence D. Phillips, David Nutt 13 citations
The two pillars of modern medical research are where in most randomized controlled trials (RCTs), the active treatment is compared with placebo. A recent expert consensus survey endorsed the statement that 'Results from placebo-controlled trials are more reliable than results from any other study design',1 reflecting that placebo controlled RCTs are considered to be the gold standard.
October 19, 2022 Stefan Baumann, Robin Carhart-Harris, David Nutt et al. 2 citations preprint
Microdosing is the practice of regularly using very low doses of psychedelic drugs. Anecdotal reports suggest that it may enhance well-being, creativity and cognition. Here, we use data from a self-blinding microdose trial, a large (n=240) placebo-controlled citizen science trial of microdosing to investigate whether tolerance develops during microdosing. We conceptualized tolerance as the...
Elife March 2, 2021 Balázs Szigeti, Laura Kärtner, Allan Blemings et al. 192 citations
Microdosing is the practice of regularly using low doses of psychedelic drugs. Anecdotal reports suggest that microdosing enhances well-being and cognition; however, such accounts are potentially biased by the placebo effect. This study used a 'self-blinding' citizen science initiative, where participants were given online instructions on how to incorporate placebo control into their...
December 11, 2020 Balázs Szigeti, Laura Kärtner, Allan Blemings et al. 1 citation
Psychedelic psychotherapy, therapy enhanced with psychedelic drugs such as LSD or psilocybin (the active ingredient of ‘magic mushrooms’), has been suggested to improve psychological well-being. For this reason, trials on psychedelic therapy for the treatment of depression, addiction and other conditions are ongoing. Recently, ‘microdosing’ – a way of administering psychedelics that involves...
Journal of Psychopharmacology May 7, 2018 Balázs Szigeti, Adam Winstock, David Erritzøe et al. 17 citations
BACKGROUND: Neuroimaging studies imply that the regular use of ±3,4-methylenedioxymethamphetamine (MDMA), the major constituent of ecstasy pills, alters the brain's serotonergic system in a dose-dependent manner. However, the relevance of these findings remains unclear due to limited knowledge about the ecstasy/MDMA use pattern of real-life users. AIMS: We examined the representativeness of...
Balázs Szigeti 1 citation 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...
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...