[1] review · 2025
Queen's University; Diamond Therapeutics Inc. — ClinicalTrials.gov
Recruiting Phase 2a study of daily 3 mg psilocybin oral solution for GAD with open-label run-in, responder randomization, and EEG/cognitive endpoints.
[2] review · 2025
Soares C et al. / Queen's University & KHSC Research Institute — Queen's Faculty of Health Sciences announcement
Health Canada-approved Phase 2a program testing daily at-home non-hallucinogenic/micro-dose psilocybin for GAD (target up to ~60 participants).
[3] review · 2025
PsilOCD investigator consortium — JMIR Research Protocols / PMC full text
Protocol for an active-controlled psilocybin challenge in OCD-spectrum pathology focusing on cognitive flexibility, EEG markers, and frontostriatal correlates.
[4] review · 2025
Open-label OCD psilocybin-assisted psychotherapy investigators — BMJ Open / PMC full text
Open-label pilot protocol assessing feasibility and preliminary effects of psilocybin-assisted psychotherapy in treatment-resistant OCD.
[5] randomized controlled trial · 2024
Incannex Healthcare / Liknaitzky P (Monash Clinical Psychedelic Lab collaboration) — Company clinical disclosure (NASDAQ: IXHL)
PsiGAD1 (N=73) met its primary endpoint: HAM-A fell 12.8 points with psilocybin-assisted therapy versus 3.6 with psychotherapy plus placebo (p<0.0001); 44% response and 27% remission reported.
[6] review · 2024
Incannex Healthcare Limited / Clerkenwell Health (ISRCTN14487299) — ISRCTN Registry
Ongoing multi-center protocol comparing 5 mg versus 25 mg psilocybin with psychological support in GAD, including participants with or without concurrent SSRIs.
DOI: 10.1186/ISRCTN14487299
[7] review · 2024
Feifel D / Kadima Neuropsychiatry; sponsor Reunion Neuroscience — Clinical trial recruitment / sponsor protocol summary
Recruiting placebo-controlled GAD trial of RE104, a psilocybin prodrug formulation designed for a compressed psychedelic experience under medical supervision.
[8] randomized controlled trial · 2022
Goodwin GM, Aaronson ST, Alvarez O, et al. — New England Journal of Medicine
A single 25 mg dose of synthetic psilocybin reduced depression severity versus a 1 mg control dose in treatment-resistant depression, with dose-related adverse events noted.
DOI: 10.1056/NEJMoa2206443
[9] observational · 2022
Gukasyan N, Davis AK, Barrett FS, et al. — Journal of Psychopharmacology
Antidepressant effects after psilocybin-assisted therapy remained substantial for many participants at 12-month follow-up, supporting durability signals beyond acute response.
DOI: 10.1177/02698811211073759
[10] randomized controlled trial · 2022
Bogenschutz MP, Ross S, Bhatt S, et al. — JAMA Psychiatry
Psilocybin-assisted psychotherapy reduced heavy drinking days versus active placebo plus psychotherapy in adults with alcohol use disorder.
DOI: 10.1001/jamapsychiatry.2022.2096
[11] randomized controlled trial · 2021
Davis AK, Barrett FS, May DG, et al. — JAMA Psychiatry
Psilocybin-assisted therapy produced large, rapid, and sustained antidepressant effects compared with waitlist in adults with major depressive disorder.
DOI: 10.1001/jamapsychiatry.2020.3285
[12] systematic review · 2021
Castro Santos H, Gama Marques J — Primary Care Companion for CNS Disorders / related clinical literature
Reviewed nine psychedelic-assisted clinical trials across anxiety indications and reported encouraging symptom reductions with an acceptable reported safety profile.
[13] open label · 2020
Anderson BT, Danforth A, Daroff R, et al. — EClinicalMedicine
Group psilocybin-assisted therapy showed feasibility and reductions in demoralization, illustrating candidate use beyond classical mood-disorder indications.
DOI: 10.1016/j.eclinm.2020.100539
[14] systematic review · 2020
Goldberg SB, Shechet B, Nicholas CR, Ng CW, Deole G, Chen Z, Raison CL — Psychological Medicine
Pooled 34 studies (n=549) and found large post-acute between-group effects of classical psychedelics on psychiatric symptoms, affect, social, and existential outcomes, including anxiety-relevant domains.
DOI: 10.1017/S003329172000389X
[15] review · 2018
Rucker JJH, Iliff J, Nutt DJ — Neuropharmacology
Reviews historical and contemporary psychiatric use of psychedelics, including safety considerations, study design challenges, and research priorities.
DOI: 10.1016/j.neuropharm.2017.12.040
[16] observational · 2017
Carhart-Harris RL, Roseman L, Bolstridge M, et al. — Scientific Reports
fMRI findings linked clinical improvement after psilocybin to altered connectivity patterns, including changes involving default-mode network dynamics.
DOI: 10.1038/s41598-017-00392-5
[17] open label · 2016
Carhart-Harris RL, Bolstridge M, Rucker J, et al. — The Lancet Psychiatry
Early clinical signal that psilocybin with psychological support can reduce depressive symptoms in treatment-resistant depression, with rapid onset in a small feasibility cohort.
DOI: 10.1016/S2215-0366(16)30065-7
[18] randomized controlled trial · 2016
Griffiths RR, Johnson MW, Carducci MA, et al. — Journal of Psychopharmacology
High-dose psilocybin produced large and sustained decreases in depression and anxiety among patients with life-threatening cancer diagnoses.
DOI: 10.1177/0269881116675513
[19] randomized controlled trial · 2016
Ross S, Bossis A, Guss J, et al. — Journal of Psychopharmacology
NYU crossover RCT using psilocybin versus niacin control found rapid, robust, and sustained reductions in cancer-related anxiety and depression.
DOI: 10.1177/0269881116675512
[20] open label · 2014
Johnson MW, Garcia-Romeu A, Cosimano MP, Griffiths RR — Journal of Psychopharmacology
Pilot data suggested high smoking abstinence rates after psilocybin combined with cognitive-behavioral support, motivating larger controlled trials.
DOI: 10.1177/0269881114548296
[21] randomized controlled trial · 2011
Grob CS, Danforth AL, Chopra GS, et al. — Archives of General Psychiatry
Early UCLA pilot (N=12) found psilocybin feasible and safe in advanced cancer anxiety, with significant trait-anxiety reductions at 1–3 months.
DOI: 10.1001/archgenpsychiatry.2010.116
[22] review · 2011
van Amsterdam J, Opperhuizen A, van den Brink W — Regulatory Toxicology and Pharmacology
Dutch CAM risk assessment concluded low dependence potential overall, while highlighting unpredictable acute panic-attack provocation as a key unsupervised-use concern.
DOI: 10.1016/j.yrtph.2011.01.006
[23] review · 2008
Johnson MW, Richards WA, Griffiths RR — Journal of Psychopharmacology
Foundational safety framework for human psychedelic research covering screening, set and setting, session monitoring, and aftercare.
DOI: 10.1177/0269881108093587
[24] open label · 2006
Moreno FA, Wiegand CB, Taitano EK, Delgado PL — Journal of Clinical Psychiatry
Marked acute reductions in OCD symptoms were observed in a very small sample; evidence remains preliminary and requires modern controlled replication.
DOI: 10.4088/JCP.v67n1103