[1] randomized controlled trial · 2026
Hendricks PS, Lappan SN, Shelton RC, et al. — JAMA Network Open
Among 40 adults with cocaine use disorder, psilocybin increased cocaine-abstinent days, raised odds of complete abstinence, and reduced lapse hazard versus active placebo through 180 days, with no serious adverse events.
DOI: 10.1001/jamanetworkopen.2026.11029
[2] randomized controlled trial · 2026
Mertens LJ, Koslowski M, Betzler F, et al. — JAMA Psychiatry
German two-centre EPIsoDE trial (n=144 TRD) tested 25 mg vs 5 mg vs nicotinamide active placebo with psychotherapy; clinically meaningful symptom reductions were observed, but the primary efficacy comparison was inconclusive/nonsignificant, and serious adverse reactions including panic/HPPD-spectrum sequelae were reported.
DOI: 10.1001/jamapsychiatry.2026.0132
[3] 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.
[4] 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).
[5] 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.
[6] 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.
[7] systematic review · 2025
Borgogna NC, Owen T, Petrovitch D, et al. — Psychopharmacology
Across nine RCTs (n≈602), psilocybin was moderately superior to controls for depression (g≈0.62), with heterogeneous effects, high risk of bias in many trials, incomplete harms reporting, and attenuation of effects in larger/better-controlled studies.
DOI: 10.1007/s00213-025-06788-w
[8] systematic review · 2025
Swieczkowski D, Kwaśny A, Pruc M, et al. — Psychiatry Research
Network meta-analysis of placebo-controlled MDD RCTs favoured a 25 mg dose for MADRS reduction at days 8 and 15, with higher adverse-event risk (notably nausea) versus placebo.
DOI: 10.1016/j.psychres.2024.116337
[9] open label · 2025
McGowan NM, Rucker JJ, Yehuda R, et al. — Journal of Psychopharmacology
In 22 adults with PTSD, a single 25 mg COMP360 dose with psychological support was generally well tolerated (no serious AEs) and associated with large CAPS-5 reductions and functional gains sustained to 12 weeks.
DOI: 10.1177/02698811251362390
[10] review · 2025
Meshkat S, Zeifman RJ, Stewart K, et al. — PLOS ONE
Protocol combining a single 25 mg psilocybin dose with one week of massed cognitive processing therapy for chronic PTSD; eligibility excludes history or current primary DID alongside psychosis-spectrum and several other psychiatric diagnoses.
DOI: 10.1371/journal.pone.0313741
[11] review · 2025
Elfrink S, Bergin L — Frontiers in Psychology
Proposes psychedelic iatrogenic structural dissociation (PISD): that psychedelics may reactivate dissociated traumatic material and destabilise the balance between apparently normal and emotional personality parts, with risk of identity fragmentation, derealization, and lasting adverse effects especially after early trauma.
DOI: 10.3389/fpsyg.2025.1528253
[12] randomized controlled trial · 2025
Kelmendi B, Ching THW, Pittenger C, et al. — OSF Preprints / Sciety (preprint; peer-review status evolving)
Preprint report of NCT03356483 (n=28): single 0.25 mg/kg psilocybin produced large acute Y-BOCS reductions versus niacin at 48 hours, with high one-week response rates and benefit persisting through 12 weeks in the psilocybin arm.
[13] observational · 2025
Ching THW, et al. — Frontiers in Psychiatry
IPA of participant narratives from the Yale OCD RCT describes acute perceptual/metacognitive/emotional effects and post-dosing shifts in OCD symptoms and illness self-appraisal under unstructured psychological support.
DOI: 10.3389/fpsyt.2025.1726818
[14] 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.
[15] 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
[16] 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.
[17] systematic review · 2024
Metaxa A-M, Clarke M — The BMJ
Pooled RCT evidence supported a moderate antidepressant benefit for psilocybin versus comparators (corrected analyses after an expression of concern about initial SMD calculation errors); certainty remains limited by bias and blinding challenges.
DOI: 10.1136/bmj-2023-078084
[18] review · 2024
Rougemont-Bücking A, Guenot F, Salamin V, Gothuey I, Duffour C, King-Olivier J, Girard V, Naudin J — European Journal of Trauma & Dissociation
Theoretical review arguing psychedelic-augmented psychotherapy may help resolve traumatic dissociation via the structural dissociation model (ANP/EP), while stressing trauma-informed, phase-oriented care; not a DID-specific efficacy trial.
DOI: 10.1016/j.ejtd.2024.100431
[19] review · 2024
Purcell JB, Brand B, Browne HA, Chefetz RA, Shanahan M, Bair ZA, Baranowski KA, Davis V, Mangones P, Modell RL, Palermo CA, Robertson EC, Robinson MA, Ward L, Winternitz S, Kaufman ML, Lebois LAM — Expert Review of Neurotherapeutics
Reviews DID phenomenology, empirically supported psychotherapy, limited pharmacology for dissociative symptoms in related conditions, and emerging neurobiology; does not establish psilocybin as a DID treatment.
DOI: 10.1080/14737175.2024.2316153
[20] systematic review · 2024
Sabé M, Sulstarova A, Glangetas A, et al. — Molecular Psychiatry
Pooled incidence of psychedelic-induced psychosis was very low in population samples but higher in older schizophrenia UCTs; about 13% of induced-psychosis cases later developed schizophrenia, reinforcing screening exclusions.
DOI: 10.1038/s41380-024-02800-5
[21] systematic review · 2024
Yildirim B, Sahin SS, Gee A, et al. — Psychological Medicine
Compiled credible case reports of schizophrenia-spectrum and major affective disorders after psychedelic use; recovery was common for affective presentations but less consistent for schizophrenia-spectrum outcomes.
DOI: 10.1017/S0033291724002496
[22] case report · 2024
Wahba M, et al. — BJPsych Open
Phase 2b TRD trial participant developed worsened suicidal ideation and prolonged post-dose nausea/restricted eating after 25 mg synthetic psilocybin, illustrating serious adverse trajectories even under supervised conditions.
DOI: 10.1192/bjo.2024.768
[23] case report · 2024
Morris SL — Clinical Psychopharmacology and Neuroscience
Male patient with depression and predisposing risk factors developed psychotic, depressive, and catatonic symptoms after months of heavy psilocybin use, underscoring elevated risk outside screened research settings.
DOI: 10.9758/cpn.24.1180
[24] randomized controlled trial · 2023
Raison CL, Sanacora G, Woolley J, et al. — JAMA
In 104 adults with MDD, a single 25 mg psilocybin dose with psychological support reduced MADRS versus niacin at day 43 (mean difference −12.3) with no serious TEAEs, though overall and severe adverse events were more common with psilocybin.
DOI: 10.1001/jama.2023.14530
[25] systematic review · 2023
Perez N, Langlest F, Mallet L, et al. — European Neuropsychopharmacology
Dose-response modelling across depression RCTs estimated population-specific effective doses and documented dose-linked adverse effects including physical discomfort, nausea, headache, and rare prolonged psychosis risk signals.
DOI: 10.1016/j.euroneuro.2023.07.011
[26] review · 2023
Ching THW, Grazioplene R, Bohner C, et al. — Frontiers in Psychiatry
Yale protocol (NCT03356483) for single-dose 0.25 mg/kg psilocybin versus niacin in treatment-refractory OCD with 48-hour primary clinical endpoint and neuroimaging.
DOI: 10.3389/fpsyt.2023.1178529
[27] case report · 2023
Research Square preprint authors (exposure + psilocybin-assisted psychotherapy case) — Research Square (preprint)
Preprint case describing three sessions of psilocybin-assisted psychotherapy combined with imaginal and in vivo elevator exposure for GAD with claustrophobia, with reported reductions in STAI/Fear Questionnaire scores and broader approach behaviour.
DOI: 10.21203/rs.3.rs-2859973/v1
[28] case report · 2023
Kinderlehrer DA — International Medical Case Reports Journal
70-year-old male with neuropsychiatric Lyme disease reported remission of refractory depression and anxiety on 100–125 mg dried-mushroom microdoses three times weekly, sustained at two-year follow-up in the report.
[29] 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
[30] 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
[31] 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
[32] case report · 2022
Kelmendi B, Kichuk SA, DePalmer G, et al. — Heliyon
Detailed one-year follow-up of an early NCT03356483 participant: Y-BOCS fell from the severe range to near-zero after a single 0.25 mg/kg supervised psilocybin dose with unstructured support.
DOI: 10.1016/j.heliyon.2022.e12135
[33] 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
[34] 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.
[35] randomized controlled trial · 2021
Carhart-Harris R, Giribaldi B, Watts R, et al. — New England Journal of Medicine
Head-to-head comparison of two 25 mg psilocybin sessions versus escitalopram over six weeks; primary QIDS-SR-16 endpoint did not differ significantly, while several secondary outcomes favoured psilocybin without multiplicity correction.
DOI: 10.1056/NEJMoa2032994
[36] case report · 2021
Lugo-Radillo A, Cortes-Lopez JL — Journal of Psychoactive Drugs
Adult male with OCD reported clinically meaningful long-term symptom reduction associated with ongoing consumption of psilocybin-containing mushrooms; uncontrolled and purity/dose unverified.
DOI: 10.1080/02791072.2020.1849879
[37] 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
[38] 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
[39] 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
[40] 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
[41] observational · 2017
Johnson MW, Garcia-Romeu A, Griffiths RR — The American Journal of Drug and Alcohol Abuse
Biologically verified abstinence after the Johns Hopkins psilocybin smoking-cessation pilot remained high at 12 months (67%) and at longer follow-up (≈60% at mean 30 months).
DOI: 10.3109/00952990.2016.1170135
[42] 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
[43] 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
[44] 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
[45] open label · 2015
Bogenschutz MP, Forcehimes AA, Pommy JA, Wilcox CE, Barbosa PC, Strassman RJ — Journal of Psychopharmacology
In ten adults with alcohol dependence, abstinence rose after supervised psilocybin plus motivational enhancement therapy, with gains largely maintained to 36 weeks and no significant treatment-related serious adverse events.
DOI: 10.1177/0269881114565144
[46] 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
[47] case report · 2014
Wilcox JA — Journal of Psychoactive Drugs
Case description of a treatment-refractory OCD patient reporting multi-year symptom relief with intermittent self-administered psilocybin mushrooms (~2 g dried every few weeks).
DOI: 10.1080/02791072.2014.963754
[48] 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
[49] 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
[50] 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
[51] 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