The New England journal of medicine
November 3, 2022
Guy M Goodwin, Scott T Aaronson, Oscar Alvarez et al.
1,095 citations
A single 25 mg dose of psilocybin, but not 10 mg, reduced depression scores more than a 1 mg control dose over three weeks in adults with treatment-resistant depression. In this phase 2 trial, 233 participants were randomly assigned to 25 mg, 10 mg, or 1 mg of synthetic psilocybin with psychological support. The 25 mg group showed an average 12-point drop on the MADRS depression scale versus a 5.4-point drop in the 1 mg group, a significant difference. The 10 mg group did not differ significantly from control. Response and remission rates at three weeks supported the primary result, but sustained response at 12 weeks was not significantly different.
Journal of Psychopharmacology
January 1, 2022
James Rucker, Lindsey Marwood, Riikka-Liisa Johanna Ajantaival et al.
101 citations
A single dose of 10 or 25 mg psilocybin, given simultaneously to up to six healthy adults with one-to-one psychological support, did not impair cognitive function or emotional processing. Over 500 treatment-emergent adverse events were reported, mostly mild and resolving within a day, with no serious events or study withdrawals. Cognitive performance, measured by a Cambridge Neuropsychological Test Automated Battery global composite score and domain scores, showed no clinically relevant differences between psilocybin and placebo groups. The findings suggest that these doses of psilocybin are generally well tolerated and safe for cognitive function in the short and long term.
Brazilian Journal of Psychiatry
July 3, 2020
Simon Ruffell, Nige Netzband, Catherine Bird et al.
43 citations
Ayahuasca, a South American psychoactive plant brew used in traditional spiritual and cultural rituals, has been studied primarily for the prevention of deamination of N,N-dimethyltryptamine (DMT) by monoamine oxidase inhibitors (MAOIs) in the brew. Two constituents, DMT and harmine, have received more research attention than secondary harmala alkaloids. Current evidence suggests that the pharmacological interactions in ayahuasca may act synergistically or additively to produce psychoactive effects, but the understanding of these synergistic mechanisms is limited and more complex processes may be involved. There is not yet enough data to determine any potential synergistic interaction between the known compounds, and increased pharmacological understanding is needed to avoid potential risks.
BMJ Open
December 1, 2021
James Rucker, Hassan Jafari, Tim Mantingh et al.
23 citations
A randomized, placebo-controlled trial is testing the feasibility of psilocybin-assisted therapy for people with major depressive disorder who have not responded to at least two prior treatments. Up to 60 participants in London, UK receive either 25 mg psilocybin or a placebo in a single dosing session, along with psychological therapy. The primary outcomes are recruitment rates, dropout rates, and variance in depression scores measured by the Montgomery Asberg Depression Rating Scale at 3 and 6 weeks. The trial also collects neuroimaging and omics data and offers an open-label extension dose of psilocybin.
Headache The Journal of Head and Face Pain
September 20, 2024
James Rucker, Sadie Hambleton, Catherine Bird et al.
12 citations
A small open-label trial tested low doses of psilocybin (5, 7.5, and 10 mg) with psychological support in four patients with chronic short-lasting unilateral neuralgiform headache attacks (SUNHA), a severe headache disorder. The study was terminated early due to recruitment difficulties; three participants completed all sessions. No significant adverse events occurred. Cognitive testing during the acute drug experience was not possible because participants reported high subjective dose intensity. Headache impact remained severe throughout the trial. Mean daily attack frequency decreased by more than 50% in two participants at final follow-up. Thematic analysis of clinical notes suggested psychological insights, including reconfigured relationships to headache pain, were key features of participants' experience. The clinical results provide no conclusive evidence for psilocybin in SUNHA.
Wellcome open research
January 1, 2024
Matt Butler, Catherine Bird, Carolina Maggio et al.
4 citations
Functional neurological disorder (FND) causes seizures and movement disorders, is debilitating, and often has a poor prognosis. Brain imaging suggests FND involves multiple networks, and mechanisms like dissociation and abnormal motor agency may play a role. Psychedelics disrupt brain networks and are being tested for neuropsychiatric disorders. This open-label neuroimaging study will give 25 mg oral psilocybin with psychological support to 24 people with chronic FND. Resting-state and task-based fMRI, plus measures of interoception, somatisation, and dissociation, will be collected before and after psilocybin, with three-month follow-up. The study aims to probe FND mechanisms and assess safety and feasibility of psychedelic administration in this population.
Wellcome Open Research
April 22, 2025
Matthew Butler, Catherine Bird, Carolina Maggio et al.
3 citations
Functional neurological disorder (FND) is a common, debilitating condition linked to abnormal brain networks, dissociation, interoception, and motor agency. This open-label neuroimaging protocol will administer 25 mg of oral psilocybin with psychological support to 24 people with chronic FND. Resting-state and task-based functional MRI sequences will be compared before and after psilocybin. Additional measures include interoception, somatisation, illness perceptions, suggestibility, and dissociation. Participants will be followed for three months. The study aims to probe mechanisms underlying FND and assess the safety and feasibility of psychedelic administration with psychological support in this population.
Journal of Psychopharmacology
January 26, 2026
Jess Kerr-Gaffney, Samuel Myrtle, Famia Askari et al.
2 citations
A single dose of psilocybin, compared to an inert placebo, did not alter personality traits, psychiatric symptoms, or cognitive flexibility in healthy participants. However, both the 10 mg and 25 mg psilocybin groups reported greater changes in personal values at both short-term (day 8) and long-term follow-up (day 85). The acute psychedelic experience, particularly the feeling of oceanic boundlessness, partially explained these value changes, with auditory alterations also playing a role in one subscale. These exploratory findings are tentative and require replication in larger samples.
Journal of Psychopharmacology
February 27, 2026
Claire T. Roberts, Mathieu Seynaeve, Anna O. Ermakova et al.
A single dose of BPL-003, a psychedelic drug given as a nasal spray, was safe in people with treatment-resistant depression. Depression scores dropped quickly and stayed lower for 12 weeks, suggesting the drug may help this hard-to-treat condition. Larger controlled trials are needed.