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psilocybin

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Description

Psilocybin is a naturally occurring psychedelic compound found in certain types of mushrooms, known as magic mushrooms. It is a tryptamine alkaloid, with a chemical structure similar to serotonin. The compound's synthesis in mushrooms is not fully understood, but it is thought to involve complex enzymatic pathways. Psilocybin itself is inactive, but once ingested, it is rapidly metabolized by the body into psilocin, which is the psychoactive component. Psilocin acts as a serotonin receptor agonist, primarily affecting the serotonin 2A receptor. This interaction leads to a wide range of effects, including altered perception, changes in mood, feelings of euphoria, and spiritual experiences. Psilocybin has a long history of use in spiritual and medicinal practices by indigenous cultures. In recent years, there has been a renewed interest in studying the therapeutic potential of psilocybin for conditions such as depression, anxiety, and addiction. Research suggests that psilocybin may have potential as a treatment for these disorders, although further research is needed. The compound is currently being investigated in clinical trials for its therapeutic effects.'

Psilocybin: The major of two hallucinogenic components of Teonanacatl, the sacred mushroom of Mexico, the other component being psilocin. (From Merck Index, 11th ed) [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

psilocybin : A tryptamine alkaloid that is N,N-dimethyltryptamine carrying an additional phosphoryloxy substituent at position 4. The major hallucinogenic alkaloid isolated from Psilocybe mushrooms (also known as Teonanacatl or "magic mushrooms"). [Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Cross-References

ID SourceID
PubMed CID10624
CHEMBL ID194378
CHEBI ID8614
SCHEMBL ID158945
MeSH IDM0017970

Synonyms (67)

Synonym
PDSP1_001391
psilocibina [inn-spanish]
psilocibin
teonanacatl
psilocybinum [inn-latin]
hsdb 7365
psilotsibin
4-phosphoryloxy-omega-n,n-dimethyltryptamine
einecs 208-294-4
brn 0273158
cy-39
indol-4-ol, 3-(2-(dimethylamino)ethyl)-, dihydrogen phosphate
1h-indol-4-ol, 3-(2-(dimethylamino)ethyl)-, dihydrogen phosphate (ester)
dea no. 7437
3-2'-dimethylaminoethylindol-4-phosphate
PDSP2_001375
520-52-5
C07576
psilocybin
psilocybine
4-phosphoryloxy-n,n-dimethyltryptamine
3-(2-(dimethylamino)ethyl)-1h-indol-4-ol dihydrogen phosphate ester
indocybin
psilocin phosphate ester
psilocibina
CHEBI:8614 ,
psilocybinum
3-(2-dimethylaminoethyl)indol-4-yl dihydrogen phosphate
3-[2-(dimethylamino)ethyl]-1h-indol-4-yl dihydrogen phosphate
o-phosphoryl-4-hydroxy-n,n-dimethyltryptamine
P-7825
cy 39
CHEMBL194378 ,
bdbm50171269
NCGC00247732-01
cas-520-52-5
tox21_112898
dtxsid0048898 ,
dtxcid0028824
psilocybine [inn:ban:dcf]
unii-2rv7212bp0
4-22-00-05665 (beilstein handbook reference)
constituent of magic mushrooms
2rv7212bp0 ,
psilocybin [mi]
cy39
(3-(2-(dimethylamino)ethyl)-1h-indol-4-yl) dihydrogen phosphate
psilocybine [hsdb]
psilocybine [who-dd]
psilocybine [inn]
psilocybine [mart.]
SCHEMBL158945
3-[2-(dimethylamino)ethyl]-1h-indol-4-yl dihydrogen phosphate #
psylocybin
1h-indol-4-ol, 3-[2-(dimethylamino)ethyl]-, dihydrogen phosphate (ester)
1h-indol-4-ol, 3-[2-(dimethylamino)ethyl]-, dihydrogen phosphate
indol-4-ol, 3-[2-(dimethylamino)ethyl]-, dihydrogen phosphate (ester)
3-[2-(dimethylamino)ethyl]indol-4-yl dihydrogen phosphate
QVDSEJDULKLHCG-UHFFFAOYSA-N
3-[2-(dimethylamino)ethyl]indol-4-ol dihydrogen phosphate ester
DB11664
Q208118
SB18760
[3-[2-(dimethylamino)ethyl]-1h-indol-4-yl] dihydrogen phosphate
({3-[2-(dimethylamino)ethyl]-1h-indol-4-yl}oxy)phosphonic acid
psilocybin 1000 microg/ml in acetonitrile:water
psilocybin, 1mg/ml in acetonitrile/water : 1/1

Research Excerpts

Overview

Psilocybin is a naturally occurring psychoactive alkaloid and non-selective agonist at many serotonin receptors, especially at serotonin 5-HT. It is produced naturally by approximately 200 species of mushrooms.

ExcerptReferenceRelevance
"Psilocybin is a naturally occurring compound derived from certain mushroom species that can induce entheogenic experiences or an altered state of consciousness."( The Role of Psilocybin-Assisted Psychotherapy to Support Patients With Cancer: A Critical Scoping Review of the Research.
Lehto, RH; Miller, M; Sender, J, 2022
)
1.82
"Psilocybin is a naturally occurring psychoactive alkaloid and non-selective agonist at many serotonin receptors, especially at serotonin 5-HT"( Molecular Mechanisms of Psilocybin and Implications for the Treatment of Depression.
Castle, D; Ceban, F; Gill, H; Ho, R; Lee, Y; Lin, K; Ling, S; Lipsitz, O; Lui, LMW; Mansur, RB; McIntyre, RS; Rodrigues, NB; Rosenblat, JD; Subramaniapillai, M; Teopiz, KM, 2022
)
1.75
"Psilocybin is a psychoactive alkaloid that is produced naturally by approximately 200 species of mushrooms. "( Psilocybin Conspectus: Status, Production Methods, and Considerations.
Gibbs, G; Graham, T; Plotnik, L, 2022
)
3.61
"Psilocybin is a naturally occurring psychedelic compound with profound perception-, emotion- and cognition-altering properties and great potential for treating brain disorders. "( Neural mechanisms underlying psilocybin's therapeutic potential - the need for preclinical in vivo electrophysiology.
Gigg, J; Neill, J; Smausz, R, 2022
)
2.46
"Psilocybin is a hallucinogenic compound that is showing promise in the ability to treat neurological conditions such as depression and post-traumatic stress disorder. "( Psilocybin reduces low frequency oscillatory power and neuronal phase-locking in the anterior cingulate cortex of awake rodents.
Chadderton, P; Golden, CT, 2022
)
3.61
"Psilocybin is a serotonin type 2A (5-HT"( Body mass index (BMI) does not predict responses to psilocybin.
Buchborn, T; Carhart-Harris, RL; Douglass, HM; Erritzoe, D; Giribaldi, B; Kärtner, LS; Lyons, T; Nutt, DJ; Rosas, FE; Roseman, L; Spriggs, MJ; Timmermann, C, 2023
)
2.6
"Psilocybin is a psychedelic with therapeutic potential. "( Shared and Distinct Brain Regions Targeted for Immediate Early Gene Expression by Ketamine and Psilocybin.
Davoudian, PA; Kwan, AC; Shao, LX, 2023
)
2.57
"Psilocybin is a psychedelic drug with growing evidence for safety and efficacy in treatment of depression."( Pilot study of single-dose psilocybin for serotonin reuptake inhibitor-resistant body dysmorphic disorder.
Cornejo, G; Feusner, J; Gomez, GJ; Hellerstein, DJ; Naraindas, AM; Schneier, FR; Wheaton, MG, 2023
)
1.93
"Psilocybin is a classic psychedelic compound that may have efficacy for the treatment of mood and substance use disorders. "( Emotions and brain function are altered up to one month after a single high dose of psilocybin.
Barrett, FS; Doss, MK; Griffiths, RR; Pekar, JJ; Sepeda, ND, 2020
)
2.23
"Psilocybin is a tryptamine-derived psychoactive alkaloid found mainly in the fungal genus Psilocybe, among others, and is the active ingredient in so-called "magic mushrooms". "( Metabolic engineering of Saccharomyces cerevisiae for the de novo production of psilocybin and related tryptamine derivatives.
Borodina, I; Kristensen, M; Milne, N; Mølgaard Knudsen, N; Rubaszka, P; Thomsen, P, 2020
)
2.23
"Psilocybin is a serotonergic psychedelic found in "magic mushrooms" with a putative therapeutic potential for treatment-resistant depression, anxiety, obsessive-compulsive disorder, and addiction. "( Transcriptional regulation in the rat prefrontal cortex and hippocampus after a single administration of psilocybin.
Elfving, B; Jefsen, OH; Müller, HK; Wegener, G, 2021
)
2.28
"Psilocybin is a serotonergic psychedelic with psychoactive effects mediated by serotonin 2A receptor (5-HT2AR) activation. "( Brain serotonin 2A receptor binding predicts subjective temporal and mystical effects of psilocybin in healthy humans.
Burmester, D; Erritzoe, D; Fisher, PM; Knudsen, GM; Kristiansen, S; Madsen, MK; Ozenne, B; Stenbæk, DS, 2021
)
2.29
"Psilocybin is a psychedelic drug that has shown lasting positive effects on clinical symptoms and self-reported well-being following a single dose. "( Lasting effects of a single psilocybin dose on resting-state functional connectivity in healthy individuals.
Fisher, PM; Jensen, PS; Knudsen, GM; Kristiansen, S; Madsen, MK; McCulloch, DE; Ozenne, B; Stenbæk, DS, 2022
)
2.46
"Psilocybin is a serotonergic psychedelic with untapped therapeutic potential. "( Psilocybin induces rapid and persistent growth of dendritic spines in frontal cortex in vivo.
Davoudian, PA; Delagarza, K; Gregg, I; Kwan, AC; Liao, C; Savalia, NK; Shao, LX, 2021
)
3.51
"Psilocybin is a psychedelic tryptamine that has shown promise in recent clinical trials for the treatment of depression and substance use disorders. "( Pharmacokinetics of Escalating Doses of Oral Psilocybin in Healthy Adults.
Brown, RT; Cooper, KM; Cozzi, NV; Gassman, MC; Henriquez, KM; Hetzel, SJ; Hutson, PR; Muller, D; Nicholas, CR; Ribaudo, AS; Thomas, CD, 2017
)
2.16
"Psilocybin is a serotonin receptor agonist with a therapeutic potential for treatment-resistant depression and other psychiatric illnesses. "( Psilocybin lacks antidepressant-like effect in the Flinders Sensitive Line rat.
Christiansen, SL; Elfving, B; Højgaard, K; Jefsen, O; Müller, HK; Nutt, DJ; Wegener, G, 2019
)
3.4
"Psilocybin is a substance of natural origin, occurring in hallucinogenic mushrooms (most common in the Psilocybe family). "( [The impact of psilocybin on visual perception and spatial orientation--neuropsychological approach].
Bala, A; Jastrzebski, M,
)
1.93
"Psilocybin is a serotonin receptor agonist that occurs naturally in some mushroom species. "( Psilocybin with psychological support for treatment-resistant depression: an open-label feasibility study.
Bloomfield, M; Bolstridge, M; Carhart-Harris, RL; Curran, VH; Day, CM; Erritzoe, D; Feilding, A; Forbes, B; Kaelen, M; Nutt, DJ; Pilling, S; Rickard, JA; Rucker, J; Taylor, D, 2016
)
3.32
"Psilocybin is a well-characterized classic hallucinogen (psychedelic) with a long history of religious use by indigenous cultures, and nonmedical use in modern societies. "( Psilocybin dose-dependently causes delayed, transient headaches in healthy volunteers.
Griffiths, RR; Johnson, MW; Sewell, RA, 2012
)
3.26
"Psilocybin is a classic psychedelic drug that has a history of use in psychotherapy. "( Implications for psychedelic-assisted psychotherapy: functional magnetic resonance imaging study with psilocybin.
Abbasi, N; Bargiotas, T; Carhart-Harris, RL; Erritzoe, D; Evans, J; Feilding, A; Hobden, P; Leech, R; Nutt, DJ; Sharp, DJ; Williams, TM; Wise, RG, 2012
)
2.04
"Psilocybin is a classic psychedelic and a candidate drug model of psychosis. "( Functional connectivity measures after psilocybin inform a novel hypothesis of early psychosis.
Carhart-Harris, RL; Erritzoe, D; Evans, J; Feilding, A; Leech, R; Nutt, DJ; Sharp, DJ; Stone, JM; Williams, TM; Wise, RG, 2013
)
2.1
"Psilocybin is a potent indoleamine hallucinogen and a mixed 5-HT2A and 5-HT1A receptor agonist."( 5-HT modulation of dopamine release in basal ganglia in psilocybin-induced psychosis in man--a PET study with [11C]raclopride.
Hell, D; Leenders, KL; Vollenweider, FX; Vontobel, P, 1999
)
1.27

Effects

Psilocybin has a low toxicity, is non-addictive and has been shown to predict favourable changes in patients with depression, anxiety and other conditions marked by rigid behavioural patterns.

Psilocybin has been shown to induce a rapid (within days) and persistent (3-12 months) improvement in human treatment-resistant depression and other neuropsychiatric conditions. It has been used for centuries for religious purposes, but little is known scientifically about its long-term effects.

ExcerptReferenceRelevance
"Psilocybin has a large, rapid, and persistent clinical effect in the treatment of resistant or end-of-life depression. "( Psilocybin Efficacy and Mechanisms of Action in Major Depressive Disorder: a Review.
Abbar, M; Becamel, C; Conejero, I; Lopez-Castroman, J; Prouzeau, D; Voyvodic, PL, 2022
)
3.61
"Psilocybin has a low toxicity, is non-addictive and has been shown to predict favourable changes in patients with depression, anxiety and other conditions marked by rigid behavioural patterns, including substance (mis)use."( Psychedelics and health behaviour change.
Carhart-Harris, RL; Douglass, H; Erritzoe, D; Johnson, MW; Kettner, H; Teixeira, PJ; Timmermann, C; Watts, R, 2022
)
1.44
"Psilocybin has shown promise for the treatment of mood disorders, which are often accompanied by cognitive dysfunction including cognitive rigidity. "( Psilocybin therapy increases cognitive and neural flexibility in patients with major depressive disorder.
Barker, PB; Barrett, FS; Davis, AK; Doss, MK; Finan, PH; Griffiths, RR; Pekar, JJ; Považan, M; Rosenberg, MD; Sepeda, ND; Smith, GS, 2021
)
3.51
"Psilocybin has generated media attention and empirical support for antidepressant effects, but lay impressions of its effectiveness are unclear."( Exploring the Credibility of Psilocybin-assisted Therapy and Cognitive-behavioral Therapy for Depression.
Altman, BR; De Leo, J; Earleywine, M,
)
1.14
"Psilocybin has been shown to catalyse a sense of 'reconnection' in participants with MDD."( Postpartum depression: A role for psychedelics?
Jairaj, C; Rucker, JJ, 2022
)
1.44
"Psilocybin has been shown to be a powerful, long-lasting antidepressant in human clinical trials and in rodent models. "( Validation of the forced swim test in Drosophila, and its use to demonstrate psilocybin has long-lasting antidepressant-like effects in flies.
Hibicke, M; Nichols, CD, 2022
)
2.39
"Psilocybin has a large, rapid, and persistent clinical effect in the treatment of resistant or end-of-life depression. "( Psilocybin Efficacy and Mechanisms of Action in Major Depressive Disorder: a Review.
Abbar, M; Becamel, C; Conejero, I; Lopez-Castroman, J; Prouzeau, D; Voyvodic, PL, 2022
)
3.61
"Psilocybin has been shown to improve symptoms of depression and anxiety when combined with psychotherapy or other clinician-guided interventions. "( Acute psilocybin enhances cognitive flexibility in rats.
Garza, G; Moghaddam, B; Olson, RJ; Torrado Pacheco, A, 2023
)
2.83
"Psilocybin, for example, has now been shown in several clinical trials to induce a rapid (within days) and persistent (3-12 months) improvement in human treatment-resistant depression and other neuropsychiatric conditions."( Preclinical perspectives on the mechanisms underlying the therapeutic actions of psilocybin in psychiatric disorders.
Nichols, CD; Thompson, SM; Wulff, AB, 2023
)
1.86
"Psilocybin has shown an antidepressant effect in cancer patients that was sustained at 6- and 12-months follow-up."(
Ibrahim, IB; Straszek, SPV; Videbech, P, 2023
)
1.63
"Psilocybin has shown promise as a treatment for depression but its therapeutic mechanisms are not properly understood. "( Therapeutic mechanisms of psilocybin: Changes in amygdala and prefrontal functional connectivity during emotional processing after psilocybin for treatment-resistant depression.
Carhart-Harris, RL; Demetriou, L; Mertens, LJ; Nutt, DJ; Roseman, L; Wall, MB, 2020
)
2.3
"Psilocybin has in some studies shown promise as treatment of major depressive disorder and psilocybin therapy was in 2019 twice designated as breakthrough therapy by the U.S. "( Effects of a single dose of psilocybin on behaviour, brain 5-HT
Donovan, LL; Hansen, HD; Issazadeh-Navikas, S; Jaberi, E; Johansen, JV; Johansen, SS; Knudsen, GM; Linnet, K; Ozenne, B; Ros, NF, 2021
)
2.36
"Psilocybin has been studied in 9 clinical trials: for the treatment of substance use disorders, depression, end-of-life anxiety, demoralization, and obsessive-compulsive disorder."( [Treatment with psilocybin: applications for patients with psychiatric disorders].
Breeksema, JJ; Koolen, MHB; Schoevers, RA; Somers, M, 2021
)
1.69
"Psilocybin has a low toxicity, is non-addictive and has been shown to predict favourable changes in patients with depression, anxiety and other conditions marked by rigid behavioural patterns, including substance (mis)use."( Psychedelics and health behaviour change.
Carhart-Harris, RL; Douglass, H; Erritzoe, D; Johnson, MW; Kettner, H; Teixeira, PJ; Timmermann, C; Watts, R, 2022
)
1.44
"Psilocybin has emerged as a potentially rapidly acting antidepressant with enduring actions. "( The cranial windows of perception.
DiBerto, JF; Roth, BL, 2021
)
2.06
"Psilocybin has recently attracted a great deal of attention as a clinical research and therapeutic tool. "( Sex differences and serotonergic mechanisms in the behavioural effects of psilocin.
Horáček, J; Kadeřábek, L; Kubešová, A; Lipski, M; Páleníček, T; Tylš, F, 2016
)
1.88
"Psilocybin has been used for centuries for religious purposes; however, little is known scientifically about its long-term effects. "( Mystical-type experiences occasioned by psilocybin mediate the attribution of personal meaning and spiritual significance 14 months later.
Griffiths, R; Jesse, R; Johnson, M; McCann, U; Richards, W, 2008
)
2.06

Treatment

Psilocybin treatment consists usually of a single oral administration of 25 mg of psilocy bin along with psychological support for 5-8 hours during the ensuing hallucinogenic trip. Treatment with p silocybin but not LSD demonstrated an immediate antidepressant-like effect, manifested as an increased number of reinforced presses and response efficiency.

ExcerptReferenceRelevance
"Psilocybin treatments were separated by at least 16 days."( Acute Effects of Psilocybin After Escitalopram or Placebo Pretreatment in a Randomized, Double-Blind, Placebo-Controlled, Crossover Study in Healthy Subjects.
Becker, AM; Duthaler, U; Eckert, A; Grandinetti, T; Grünblatt, E; Holze, F; Klaiber, A; Kolaczynska, KE; Liechti, ME; Toedtli, VE; Varghese, N, 2022
)
1.78
"Psilocybin treatment consists usually of a single oral administration of 25 mg of psilocybin along with psychological support for 5-8 hours during the ensuing hallucinogenic trip."( [The use of psilocybin for treatment-resistant depression].
Johannesdottir, A; Sigurdsson, E, 2022
)
1.82
"Psilocybin treatment was associated with significantly reduced MADRS scores compared with niacin from baseline to day 43 (mean difference,-12.3 [95% CI, -17.5 to -7.2]; P <.001) and from baseline to day 8 (mean difference, -12.0 [95% CI, -16.6 to -7.4]; P < .001)."( Single-Dose Psilocybin Treatment for Major Depressive Disorder: A Randomized Clinical Trial.
Bradley, E; Brown, C; Brown, RT; Davis, MC; Dunlop, BW; Gapasin, T; Griffiths, RR; Gukasyan, N; Hassman, M; Heinzerling, K; Hu, X; Hutson, PR; Kakar, R; Kelly, DF; Kelmendi, B; Lenoch, K; Linton, W; Mletzko, T; Nayak, SM; Nelson-Douthit, C; Nicholas, CR; O'Donnell, KC; Penn, AD; Raison, CL; Robison, R; Ross, S; Sanacora, G; Sloshower, J; Tarpley, G; Trivedi, RP; Utzinger, M; Warchol, K; Wilson, S; Woolley, J, 2023
)
2.01
"Psilocybin treatment was associated with a clinically significant sustained reduction in depressive symptoms and functional disability, without serious adverse events. "( Single-Dose Psilocybin Treatment for Major Depressive Disorder: A Randomized Clinical Trial.
Bradley, E; Brown, C; Brown, RT; Davis, MC; Dunlop, BW; Gapasin, T; Griffiths, RR; Gukasyan, N; Hassman, M; Heinzerling, K; Hu, X; Hutson, PR; Kakar, R; Kelly, DF; Kelmendi, B; Lenoch, K; Linton, W; Mletzko, T; Nayak, SM; Nelson-Douthit, C; Nicholas, CR; O'Donnell, KC; Penn, AD; Raison, CL; Robison, R; Ross, S; Sanacora, G; Sloshower, J; Tarpley, G; Trivedi, RP; Utzinger, M; Warchol, K; Wilson, S; Woolley, J, 2023
)
2.73
"Treatment with psilocybin but not LSD demonstrated an immediate antidepressant-like effect, manifested as an increased number of reinforced presses and response efficiency. "( Acute but not long-lasting antidepressant-like effect of psilocybin in differential reinforcement of low-rate 72 schedule in rats.
Golebiowska, J; Koniewski, M; Malikowska-Racia, N; Popik, P, 2023
)
1.51

Toxicity

We have analyzed all randomized, double-blind, and controlled trials that assessed the antidepressant effects of psilocybin and LSD in clinical populations to date. We take special attention to adverse events (AEs) related to their use.

ExcerptReferenceRelevance
" One subject experienced transient hypertension without relation to anxiety or somatic symptoms, but no other significant adverse effects were observed."( Safety, tolerability, and efficacy of psilocybin in 9 patients with obsessive-compulsive disorder.
Delgado, PL; Moreno, FA; Taitano, EK; Wiegand, CB, 2006
)
0.6
" When the pure psilocin or fungal extracts were used, slight differences in determined LD50 values were observed."( Research on acute toxicity and the behavioral effects of methanolic extract from psilocybin mushrooms and psilocin in mice.
Godovan, VV; Halama, M; Jasicka-Misiak, I; Kazakova, A; Poliwoda, A; Wieczorek, PP; Zhuk, O, 2015
)
0.64
" Although several pharmacological treatments are available, they are not effective for a significant proportion of patients and are associated with several adverse reactions."( Efficacy, tolerability, and safety of serotonergic psychedelics for the management of mood, anxiety, and substance-use disorders: a systematic review of systematic reviews.
Alcázar-Córcoles, MÁ; Bouso, JC; Dos Santos, RG; Hallak, JEC, 2018
)
0.48
" Results support medicinal safe use of mushrooms under controlled conditions and cautioned use of higher concentrations."( Effects and safety of Psilocybe cubensis and Panaeolus cyanescens magic mushroom extracts on endothelin-1-induced hypertrophy and cell injury in cardiomyocytes.
Eloff, JN; Nkadimeng, SM; Steinmann, CML, 2020
)
0.56
" Adverse cardiac events after intake of high doses of psilocybin and a trial reporting QT interval prolongation in the electrocardiogram attributed to the drug's main metabolite, psilocin, gave rise to safety concerns."( Psilocybin Therapy of Psychiatric Disorders Is Not Hampered by hERG Potassium Channel-Mediated Cardiotoxicity.
Hackl, B; Hilber, K; Koenig, X; Kubista, H; Todt, H, 2022
)
2.41
" We explore the evidence base for these adverse effects to elucidate which of these harms are based largely on anecdotes versus those that stand up to current scientific scrutiny."( Adverse effects of psychedelics: From anecdotes and misinformation to systematic science.
Aday, J; Neill, JC; Nutt, DJ; Salam, I; Schlag, AK, 2022
)
0.72
"Our review shows that medical risks are often minimal, and that many - albeit not all - of the persistent negative perceptions of psychological risks are unsupported by the currently available scientific evidence, with the majority of reported adverse effects not being observed in a regulated and/or medical context."( Adverse effects of psychedelics: From anecdotes and misinformation to systematic science.
Aday, J; Neill, JC; Nutt, DJ; Salam, I; Schlag, AK, 2022
)
0.72
"We have analyzed all randomized, double-blind, and controlled trials that assessed the antidepressant effects of psilocybin and LSD in clinical populations to date, taking special attention to adverse events (AEs) related to their use."( Safety issues of psilocybin and LSD as potential rapid acting antidepressants and potential challenges.
Bouso Saiz, JC; Dos Santos, RG; Hallak, JEC; Rossi, GN, 2022
)
1.27
" Streamlining access to safe and evidence-based compassionate use of PAP will provide a timely treatment option to those currently in need while encouraging further research and outcome surveillance to refine best practices."( Safety considerations in the evolving legal landscape of psychedelic-assisted psychotherapy.
Argento, E; Christie, D; Mackay, L; Mocanu, V, 2022
)
0.72
" Before psychedelics become registered medicines, it is important to know the full range of adverse events (AEs) for making balanced treatment decisions."( Adverse events in clinical treatments with serotonergic psychedelics and MDMA: A mixed-methods systematic review.
Breeksema, JJ; Kamphuis, J; Kuin, BW; Schoevers, RA; van den Brink, W; Vermetten, E, 2022
)
0.72
" Adverse events associated with psychedelics were reported as mild and transient."( A Critical Appraisal of Evidence on the Efficacy and Safety of Serotonergic Psychedelic Drugs as Emerging Antidepressants: Mind the Evidence Gap.
Blumberger, DM; Castle, DJ; Husain, MI; Ledwos, N; McIntyre, RS; Mulsant, BH; Rosenblat, JD,
)
0.13
" The primary safety outcome will be the type, severity and frequency of adverse events and suicidal ideation/behaviour, as measured by the Columbia Suicide Severity Rating Scale."( Study protocol of an open-label proof-of-concept trial examining the safety and clinical efficacy of psilocybin-assisted therapy for veterans with PTSD.
Armstrong, SB; Davis, AK; Lancelotta, RL; Levin, AW; Nagib, PB, 2023
)
1.13
"The pharmacological treatment of depression consists of taking antidepressant drugs for prolonged periods; its modest therapeutic effect can often be associated with significant adverse effects, while its discontinuation can lead to relapses."( A Proposal to Study the Safety and Efficacy of
Escamilla, R; González Mariscal, JM; González-Trujano, ME; Guzmán-González, H; Loizaga-Velder, A; Torres-Valencia, JM; Vega, JL,
)
0.13
" Psychedelics are generally considered to be physiologically safe with low toxicity and low addictive potential."( Cardiovascular safety of psychedelic medicine: current status and future directions.
Wsół, A, 2023
)
0.91

Pharmacokinetics

ExcerptReferenceRelevance
"In order to investigate the pharmacokinetic properties of psilocybin (PY), the main psychoactive compound of Psilocybe mushrooms, high performance liquid chromatographic procedures with column-switching coupled with electrochemical detection (HPLC-ECD) for reliable quantitative determination of the PY metabolites psilocin (PI) and 4-hydroxyindole-3-acetic acid (4HIAA) in human plasma were established."( Determination of psilocin and 4-hydroxyindole-3-acetic acid in plasma by HPLC-ECD and pharmacokinetic profiles of oral and intravenous psilocybin in man.
Bär, T; Bourquin, D; Brenneisen, R; Hasler, F; Vollenweider, FX, 1997
)
0.74

Compound-Compound Interactions

As MDMA and psilocybin continue to move through the FDA drug development process, this systematic review offers a compilation of existing research on psychiatric drug-drug interactions.

ExcerptReferenceRelevance
", selective serotonin reuptake inhibitors), so it will be important to understand drug-drug interactions between MDMA or psilocybin and psychiatric medications."( Drug-drug interactions between psychiatric medications and MDMA or psilocybin: a systematic review.
Malcolm, B; Sarparast, A; Stauffer, CS; Thomas, K, 2022
)
1.17
" We focus our results on pharmacodynamic, physiological, and subjective outcomes of drug-drug interactions."( Drug-drug interactions between psychiatric medications and MDMA or psilocybin: a systematic review.
Malcolm, B; Sarparast, A; Stauffer, CS; Thomas, K, 2022
)
0.96
"As MDMA and psilocybin continue to move through the FDA drug development process, this systematic review offers a compilation of existing research on psychiatric drug-drug interactions with MDMA or psilocybin."( Drug-drug interactions between psychiatric medications and MDMA or psilocybin: a systematic review.
Malcolm, B; Sarparast, A; Stauffer, CS; Thomas, K, 2022
)
1.34

Bioavailability

ExcerptReferenceRelevance
" Estimates for the absolute bioavailability of PI after oral administration of PY were 52."( Determination of psilocin and 4-hydroxyindole-3-acetic acid in plasma by HPLC-ECD and pharmacokinetic profiles of oral and intravenous psilocybin in man.
Bär, T; Bourquin, D; Brenneisen, R; Hasler, F; Vollenweider, FX, 1997
)
0.5
"The ATP-binding cassette transporter P-glycoprotein (P-gp) is known to limit both brain penetration and oral bioavailability of many chemotherapy drugs."( A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
Ambudkar, SV; Brimacombe, KR; Chen, L; Gottesman, MM; Guha, R; Hall, MD; Klumpp-Thomas, C; Lee, OW; Lee, TD; Lusvarghi, S; Robey, RW; Shen, M; Tebase, BG, 2019
)
0.51

Dosage Studied

Psilocybin is increasingly studied for its antidepressant effect, but its optimal dosage for depression remains unclear. Most earlier models explain minimal response variation, primarily related to dosage and trust. We applied a linear meta-regression approach to obtain linear dose-response relationship estimates on questionnaire ratings.

ExcerptRelevanceReference
"70 mg/kg) doses of psilocin also had a biphasic dose-response effect on startle comparable in magnitude to equimolar doses of psilocybin."( Psilocybin: biphasic dose-response effects on the acoustic startle reflex in the rat.
Davis, M; Walters, JK, 1977
)
1.91
"A dosage regimen of lysergic acid diethylamide (LSD) that reliably produces behavioral tolerance in rats was evaluated for effects on neurotransmitter receptor binding in rat brain using a variety of radioligands selective for amine receptor subtypes."( Lysergic acid diethylamide (LSD) administration selectively downregulates serotonin2 receptors in rat brain.
Buckholtz, NS; Freedman, DX; Potter, WZ; Zhou, DF, 1990
)
0.28
" Dose-response and time-response curves were obtained."( Psilocybin as a discriminative stimulus: lack of specificity in an animal behavior model for 'hallucinogens'.
Appel, JB; Koerner, J, 1982
)
1.71
" Patients were monitored for adverse reactions during the dosing sessions and subsequent clinic and remote follow-up."( Psilocybin with psychological support for treatment-resistant depression: an open-label feasibility study.
Bloomfield, M; Bolstridge, M; Carhart-Harris, RL; Curran, VH; Day, CM; Erritzoe, D; Feilding, A; Forbes, B; Kaelen, M; Nutt, DJ; Pilling, S; Rickard, JA; Rucker, J; Taylor, D, 2016
)
1.88
" In this open-label study, 20 individuals diagnosed with moderate to severe, treatment-resistant depression, underwent two separate dosing sessions with psilocybin."( Increased amygdala responses to emotional faces after psilocybin for treatment-resistant depression.
Carhart-Harris, RL; Demetriou, L; Nutt, DJ; Roseman, L; Wall, MB, 2018
)
0.93
" Psilocybin was administered in two oral dosing sessions (10 mg and 25 mg) 1 week apart."( Increased nature relatedness and decreased authoritarian political views after psilocybin for treatment-resistant depression.
Carhart-Harris, RL; Lyons, T, 2018
)
1.62
"039) for the patients 1 week after the dosing sessions."( Increased nature relatedness and decreased authoritarian political views after psilocybin for treatment-resistant depression.
Carhart-Harris, RL; Lyons, T, 2018
)
0.71
" Psychological support was provided before, during and after all dosing sessions."( Natural speech algorithm applied to baseline interview data can predict which patients will respond to psilocybin for treatment-resistant depression.
Ashton, P; Carhart-Harris, RL; Carrillo, F; Fernández Slezak, D; Fitzgerald, L; Nutt, DJ; Sigman, M; Stroud, J, 2018
)
0.7
" The present study addressed this gap by surveying psychedelic users about their experience with microdosing including their dosing schedule, motivation, and potential experienced negative effects."( Motives and Side-Effects of Microdosing With Psychedelics Among Users.
Dolder, PC; Hutten, NRPW; Kuypers, KPC; Mason, NL, 2019
)
0.51
" Most earlier models explain minimal response variation, primarily related to dosage and trust, but a recent study found that states of surrender and preoccupation at the time of ingestion explained substantial variance in mystical and adverse psilocybin experiences."( Replication and extension of a model predicting response to psilocybin.
Carhart-Harris, RL; Elliott, MS; Maruyama, G; Russ, SL, 2019
)
0.94
" We examined motivations, dosing practices, and perceived benefits and limitations of microdosing."( Psychedelic Microdosing: A Subreddit Analysis.
Amada, N; Jungaberle, H; Lea, T,
)
0.13
" This paper examines microdosing motivations, dosing practices, perceived short-term benefits, unwanted effects, and harm reduction practices."( Microdosing psychedelics: Motivations, subjective effects and harm reduction.
Amada, N; Jungaberle, H; Klein, M; Lea, T; Schecke, H, 2020
)
0.56
" In contrast to the primary hypothesis, psychedelics had no long-lasting effects on the ADE in male and female rats, neither when administered in a high dosage regime that is comparable to the one used in clinical studies, nor in a chronic microdosing scheme."( Psilocybin and LSD have no long-lasting effects in an animal model of alcohol relapse.
Güngör, C; Meinhardt, MW; Mertens, LJ; Skorodumov, I; Spanagel, R, 2020
)
2
" gender bias, heterogeneity of dosing schedules and drugs used)."( Potential safety, benefits, and influence of the placebo effect in microdosing psychedelic drugs: A systematic review.
Bouso, JC; Ona, G, 2020
)
0.56
" Dosing and the means of using the various hallucinogens were often quite varied, as were the settings where they were taken."( Peculiar plants and fantastic fungi: An ethnobotanical study of the use of hallucinogenic plants and mushrooms in Slovenia.
Fatur, K, 2021
)
0.62
"Establishing dose-response relationships of the subjective experiences induced by psilocybin in healthy study participants and a comparison of patient groups."( Dose-response relationships of psilocybin-induced subjective experiences in humans.
Hirschfeld, T; Schmidt, TT, 2021
)
1.13
"We applied a linear meta-regression approach, based on the robust variance estimation framework, to obtain linear dose-response relationship estimates on questionnaire ratings after oral psilocybin administration."( Dose-response relationships of psilocybin-induced subjective experiences in humans.
Hirschfeld, T; Schmidt, TT, 2021
)
1.1
", choosing the right patients for these therapies), (3) the dosing preparation sessions, (4) the assisted dosing sessions as well as after-care procedures such as (5) psychological integration and (6) supporting the development of structured patient communities."( The Potential Role of Psychedelic Drugs in Mental Health Care of the Future.
Gründer, G; Jungaberle, H, 2021
)
0.62
"To determine how differences in the type of psychedelic agent used and the number of dosing sessions administered affect subjects' depression and anxiety outcomes and adverse drug reactions (ADR)."( Assessing the effects of methodological differences on outcomes in the use of psychedelics in the treatment of anxiety and depressive disorders: A systematic review and meta-analysis.
Leger, RF; Unterwald, EM, 2022
)
0.72
" Controlled study data on dosing using well-characterized pharmaceutical formulations of the substances are scarce."( Dosing Psychedelics and MDMA.
Holze, F; Liechti, ME, 2022
)
0.72
" Participants are randomised to receive a single dosing session of 25 mg psilocybin or a placebo."( Psilocybin-assisted therapy for the treatment of resistant major depressive disorder (PsiDeR): protocol for a randomised, placebo-controlled feasibility trial.
Bird, C; Carter, B; Day, C; Jafari, H; Knight, G; Mantingh, T; Modlin, NL; Reinholdt, F; Rucker, J; Young, A, 2021
)
2.3
" The reported lasting clinical effects after limited dosing with psychedelics present a novel means for disease management, but considerable further study will be required to address disease-specific treatments, uncover mechanism(s) of action, and verify safety."( Psychedelics in the Treatment of Headache and Chronic Pain Disorders.
Schindler, EAD, 2022
)
0.72
", dosing schedule and imaging methods) amongst included studies."( The Effects of Psilocybin in Adults with Major Depressive Disorder and the General Population: Findings from Neuroimaging Studies.
Castle, D; Cha, DS; Gill, B; Gill, H; Mansur, RB; Marks, CA; McIntyre, RS; Patel, P; Puramat, P; Rodrigues, NB; Rosenblat, JD, 2022
)
1.07
" In addition, this article considers the effects that macro- and microdoses have on behavior and psychopathology in light of their dosage characteristics and contexts of use."( Macrodosing to microdosing with psychedelics: Clinical, social, and cultural perspectives.
Kaypak, AC; Raz, A, 2022
)
0.72
" In addition, in 1 case, repeated dosing seemed to produce increased relief, suggesting a possible long-term plasticity-mediated effect."( Microdosing psilocybin for chronic pain: a case series.
Castellanos, J; Furnish, T; Lyes, M; Yang, KH, 2023
)
1.29
" fMRI was performed 1 week prior to the first dosing session and 1 day after the second."( Changes in music-evoked emotion and ventral striatal functional connectivity after psilocybin therapy for depression.
Carhart-Harris, R; Kaelen, M; Nutt, D; Roseman, L; Shukuroglou, M; Wall, M, 2023
)
1.14
" Psychological support was provided before, during, and after the dosing session."( Pilot study of single-dose psilocybin for serotonin reuptake inhibitor-resistant body dysmorphic disorder.
Cornejo, G; Feusner, J; Gomez, GJ; Hellerstein, DJ; Naraindas, AM; Schneier, FR; Wheaton, MG, 2023
)
1.21
"All participants completed dosing and all follow-up assessments."( Pilot study of single-dose psilocybin for serotonin reuptake inhibitor-resistant body dysmorphic disorder.
Cornejo, G; Feusner, J; Gomez, GJ; Hellerstein, DJ; Naraindas, AM; Schneier, FR; Wheaton, MG, 2023
)
1.21
" Compounds with short-lived subjective effects may be clinically useful because dosing time would be reduced, which may improve patient access."( 5-MeO-DMT modifies innate behaviors and promotes structural neural plasticity in mice.
Davoudian, PA; Dibbs, M; Gregg, I; Jefferson, SJ; Kaye, AP; Kwan, AC; Liao, C; Pittenger, C; Sherwood, AM; Sprouse, JS; Wehrle, PH; Woodburn, SC; Wu, H, 2023
)
0.91
" Nineteen patients with treatment-resistant depression underwent two treatment sessions involving administration of psilocybin, with MRI data acquired one week prior and the day after completion of psilocybin dosing sessions."( Increased low-frequency brain responses to music after psilocybin therapy for depression.
Carhart-Harris, RL; Ertl, N; Kaelen, M; Lam, C; Nutt, DJ; Roseman, L; Wall, MB, 2023
)
1.37
" ALFF in these music-related clusters was significantly correlated with intensity of subjective effects felt during the dosing sessions."( Increased low-frequency brain responses to music after psilocybin therapy for depression.
Carhart-Harris, RL; Ertl, N; Kaelen, M; Lam, C; Nutt, DJ; Roseman, L; Wall, MB, 2023
)
1.16
" Still, caution is advised if psilocybin is being used, and the correct dosage should be prescribed by an appropriate physician."( Psilocybin: The most effective moral bio-enhancer?
Rakić, V, 2023
)
2.64
" In reviewing these topics, we identify three knowledge gaps as areas of future inquiry: sex differences, oral dosing rather than injection, and chronic dosing regimens."( Addressing the Current Knowledge and Gaps in Research Surrounding Lysergic Acid Diethylamide (LSD), Psilocybin, and Psilocin in Rodent Models.
Ezeaka, UC; Kim, HJJ; Laprairie, RB, 2023
)
1.13
" Nineteen participants were dosed and the mean Baseline MADRS total score was 31."( Psilocybin for treatment resistant depression in patients taking a concomitant SSRI medication.
Croal, M; Feifel, D; Goodwin, GM; Kelly, JR; Malievskaia, E; Marwood, L; Mistry, S; O'Keane, V; Peck, SK; Simmons, H; Sisa, C; Stansfield, SC; Tsai, J; Williams, S, 2023
)
2.35
"Psilocybin is increasingly studied for its antidepressant effect, but its optimal dosage for depression remains unclear."( Psilocybin-assisted therapy for depression: A systematic review and dose-response meta-analysis of human studies.
De Pieri, M; Kaiser, S; Kirschner, M; Langlest, F; Mallet, L; Perez, N; Sabé, M; Sentissi, O; Seragnoli, F; Solmi, M; Thorens, G; Zullino, D, 2023
)
3.8
" Additional studies (including controlled dose-response studies) that examine the effects and safety of co-administering MDMA with psilocybin/LSD (in healthy controls and clinical samples) are warranted and may assist the development of personalized treatments."( Co-use of MDMA with psilocybin/LSD may buffer against challenging experiences and enhance positive experiences.
Carhart-Harris, RL; Erritzoe, D; Kettner, H; Mallard, A; Pagni, BA; Roberts, DE; Ross, S; Zeifman, RJ, 2023
)
1.44
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Roles (4)

RoleDescription
hallucinogenDrugs capable of inducing illusions, hallucinations, delusions, paranoid ideations and other alterations of mood and thinking.
fungal metaboliteAny eukaryotic metabolite produced during a metabolic reaction in fungi, the kingdom that includes microorganisms such as the yeasts and moulds.
prodrugA compound that, on administration, must undergo chemical conversion by metabolic processes before becoming the pharmacologically active drug for which it is a prodrug.
serotonergic agonistAn agent that has an affinity for serotonin receptors and is able to mimic the effects of serotonin by stimulating the physiologic activity at the cell receptors. Serotonin agonists are used as antidepressants, anxiolytics, and in the treatment of migraine disorders.
[role information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Drug Classes (3)

ClassDescription
tryptamine alkaloid
tertiary amino compoundA compound formally derived from ammonia by replacing three hydrogen atoms by organyl groups.
organic phosphate
[compound class information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Protein Targets (7)

Potency Measurements

ProteinTaxonomyMeasurementAverage (µ)Min (ref.)Avg (ref.)Max (ref.)Bioassay(s)
hypoxia-inducible factor 1 alpha subunitHomo sapiens (human)Potency1.35533.189029.884159.4836AID1224846
AR proteinHomo sapiens (human)Potency23.89170.000221.22318,912.5098AID1259243
cytochrome P450 family 3 subfamily A polypeptide 4Homo sapiens (human)Potency34.93670.01237.983543.2770AID1645841
cytochrome P450 2D6Homo sapiens (human)Potency13.90860.00108.379861.1304AID1645840
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Activation Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
5-hydroxytryptamine receptor 2AHomo sapiens (human)EC50 (µMol)3.47500.00000.22763.4750AID255670
5-hydroxytryptamine receptor 2CHomo sapiens (human)EC50 (µMol)0.50600.00010.10082.4500AID255671
5-hydroxytryptamine receptor 2BHomo sapiens (human)EC50 (µMol)0.07400.00040.20611.0000AID255672
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Biological Processes (72)

Processvia Protein(s)Taxonomy
temperature homeostasis5-hydroxytryptamine receptor 2AHomo sapiens (human)
positive regulation of cytokine production involved in immune response5-hydroxytryptamine receptor 2AHomo sapiens (human)
glycolytic process5-hydroxytryptamine receptor 2AHomo sapiens (human)
intracellular calcium ion homeostasis5-hydroxytryptamine receptor 2AHomo sapiens (human)
activation of phospholipase C activity5-hydroxytryptamine receptor 2AHomo sapiens (human)
positive regulation of cytosolic calcium ion concentration5-hydroxytryptamine receptor 2AHomo sapiens (human)
memory5-hydroxytryptamine receptor 2AHomo sapiens (human)
positive regulation of cell population proliferation5-hydroxytryptamine receptor 2AHomo sapiens (human)
response to xenobiotic stimulus5-hydroxytryptamine receptor 2AHomo sapiens (human)
positive regulation of phosphatidylinositol biosynthetic process5-hydroxytryptamine receptor 2AHomo sapiens (human)
regulation of dopamine secretion5-hydroxytryptamine receptor 2AHomo sapiens (human)
artery smooth muscle contraction5-hydroxytryptamine receptor 2AHomo sapiens (human)
urinary bladder smooth muscle contraction5-hydroxytryptamine receptor 2AHomo sapiens (human)
positive regulation of heat generation5-hydroxytryptamine receptor 2AHomo sapiens (human)
negative regulation of potassium ion transport5-hydroxytryptamine receptor 2AHomo sapiens (human)
phosphatidylinositol 3-kinase/protein kinase B signal transduction5-hydroxytryptamine receptor 2AHomo sapiens (human)
positive regulation of neuron apoptotic process5-hydroxytryptamine receptor 2AHomo sapiens (human)
protein localization to cytoskeleton5-hydroxytryptamine receptor 2AHomo sapiens (human)
positive regulation of fat cell differentiation5-hydroxytryptamine receptor 2AHomo sapiens (human)
positive regulation of glycolytic process5-hydroxytryptamine receptor 2AHomo sapiens (human)
positive regulation of vasoconstriction5-hydroxytryptamine receptor 2AHomo sapiens (human)
symbiont entry into host cell5-hydroxytryptamine receptor 2AHomo sapiens (human)
sensitization5-hydroxytryptamine receptor 2AHomo sapiens (human)
behavioral response to cocaine5-hydroxytryptamine receptor 2AHomo sapiens (human)
positive regulation of inflammatory response5-hydroxytryptamine receptor 2AHomo sapiens (human)
positive regulation of peptidyl-tyrosine phosphorylation5-hydroxytryptamine receptor 2AHomo sapiens (human)
detection of temperature stimulus involved in sensory perception of pain5-hydroxytryptamine receptor 2AHomo sapiens (human)
detection of mechanical stimulus involved in sensory perception of pain5-hydroxytryptamine receptor 2AHomo sapiens (human)
release of sequestered calcium ion into cytosol5-hydroxytryptamine receptor 2AHomo sapiens (human)
negative regulation of synaptic transmission, glutamatergic5-hydroxytryptamine receptor 2AHomo sapiens (human)
positive regulation of ERK1 and ERK2 cascade5-hydroxytryptamine receptor 2AHomo sapiens (human)
G protein-coupled serotonin receptor signaling pathway5-hydroxytryptamine receptor 2AHomo sapiens (human)
presynaptic modulation of chemical synaptic transmission5-hydroxytryptamine receptor 2AHomo sapiens (human)
positive regulation of execution phase of apoptosis5-hydroxytryptamine receptor 2AHomo sapiens (human)
positive regulation of platelet aggregation5-hydroxytryptamine receptor 2AHomo sapiens (human)
positive regulation of DNA biosynthetic process5-hydroxytryptamine receptor 2AHomo sapiens (human)
G protein-coupled receptor signaling pathway, coupled to cyclic nucleotide second messenger5-hydroxytryptamine receptor 2AHomo sapiens (human)
phospholipase C-activating serotonin receptor signaling pathway5-hydroxytryptamine receptor 2AHomo sapiens (human)
serotonin receptor signaling pathway5-hydroxytryptamine receptor 2AHomo sapiens (human)
chemical synaptic transmission5-hydroxytryptamine receptor 2AHomo sapiens (human)
behavioral fear response5-hydroxytryptamine receptor 2CHomo sapiens (human)
intracellular calcium ion homeostasis5-hydroxytryptamine receptor 2CHomo sapiens (human)
phospholipase C-activating G protein-coupled receptor signaling pathway5-hydroxytryptamine receptor 2CHomo sapiens (human)
phospholipase C-activating serotonin receptor signaling pathway5-hydroxytryptamine receptor 2CHomo sapiens (human)
locomotory behavior5-hydroxytryptamine receptor 2CHomo sapiens (human)
feeding behavior5-hydroxytryptamine receptor 2CHomo sapiens (human)
positive regulation of phosphatidylinositol biosynthetic process5-hydroxytryptamine receptor 2CHomo sapiens (human)
cGMP-mediated signaling5-hydroxytryptamine receptor 2CHomo sapiens (human)
regulation of nervous system process5-hydroxytryptamine receptor 2CHomo sapiens (human)
regulation of appetite5-hydroxytryptamine receptor 2CHomo sapiens (human)
regulation of corticotropin-releasing hormone secretion5-hydroxytryptamine receptor 2CHomo sapiens (human)
positive regulation of fat cell differentiation5-hydroxytryptamine receptor 2CHomo sapiens (human)
positive regulation of calcium-mediated signaling5-hydroxytryptamine receptor 2CHomo sapiens (human)
release of sequestered calcium ion into cytosol5-hydroxytryptamine receptor 2CHomo sapiens (human)
positive regulation of ERK1 and ERK2 cascade5-hydroxytryptamine receptor 2CHomo sapiens (human)
G protein-coupled serotonin receptor signaling pathway5-hydroxytryptamine receptor 2CHomo sapiens (human)
serotonin receptor signaling pathway5-hydroxytryptamine receptor 2CHomo sapiens (human)
G protein-coupled receptor signaling pathway, coupled to cyclic nucleotide second messenger5-hydroxytryptamine receptor 2CHomo sapiens (human)
chemical synaptic transmission5-hydroxytryptamine receptor 2CHomo sapiens (human)
neural crest cell migration5-hydroxytryptamine receptor 2BHomo sapiens (human)
positive regulation of cytokine production5-hydroxytryptamine receptor 2BHomo sapiens (human)
positive regulation of endothelial cell proliferation5-hydroxytryptamine receptor 2BHomo sapiens (human)
G protein-coupled receptor internalization5-hydroxytryptamine receptor 2BHomo sapiens (human)
heart morphogenesis5-hydroxytryptamine receptor 2BHomo sapiens (human)
cardiac muscle hypertrophy5-hydroxytryptamine receptor 2BHomo sapiens (human)
intracellular calcium ion homeostasis5-hydroxytryptamine receptor 2BHomo sapiens (human)
G protein-coupled receptor signaling pathway5-hydroxytryptamine receptor 2BHomo sapiens (human)
activation of phospholipase C activity5-hydroxytryptamine receptor 2BHomo sapiens (human)
protein kinase C-activating G protein-coupled receptor signaling pathway5-hydroxytryptamine receptor 2BHomo sapiens (human)
phospholipase C-activating serotonin receptor signaling pathway5-hydroxytryptamine receptor 2BHomo sapiens (human)
positive regulation of cell population proliferation5-hydroxytryptamine receptor 2BHomo sapiens (human)
response to xenobiotic stimulus5-hydroxytryptamine receptor 2BHomo sapiens (human)
positive regulation of phosphatidylinositol biosynthetic process5-hydroxytryptamine receptor 2BHomo sapiens (human)
neural crest cell differentiation5-hydroxytryptamine receptor 2BHomo sapiens (human)
intestine smooth muscle contraction5-hydroxytryptamine receptor 2BHomo sapiens (human)
phosphorylation5-hydroxytryptamine receptor 2BHomo sapiens (human)
calcium-mediated signaling5-hydroxytryptamine receptor 2BHomo sapiens (human)
cGMP-mediated signaling5-hydroxytryptamine receptor 2BHomo sapiens (human)
vasoconstriction5-hydroxytryptamine receptor 2BHomo sapiens (human)
negative regulation of apoptotic process5-hydroxytryptamine receptor 2BHomo sapiens (human)
positive regulation of canonical NF-kappaB signal transduction5-hydroxytryptamine receptor 2BHomo sapiens (human)
positive regulation of MAP kinase activity5-hydroxytryptamine receptor 2BHomo sapiens (human)
phosphatidylinositol 3-kinase/protein kinase B signal transduction5-hydroxytryptamine receptor 2BHomo sapiens (human)
embryonic morphogenesis5-hydroxytryptamine receptor 2BHomo sapiens (human)
regulation of behavior5-hydroxytryptamine receptor 2BHomo sapiens (human)
positive regulation of nitric-oxide synthase activity5-hydroxytryptamine receptor 2BHomo sapiens (human)
release of sequestered calcium ion into cytosol5-hydroxytryptamine receptor 2BHomo sapiens (human)
positive regulation of cell division5-hydroxytryptamine receptor 2BHomo sapiens (human)
ERK1 and ERK2 cascade5-hydroxytryptamine receptor 2BHomo sapiens (human)
positive regulation of ERK1 and ERK2 cascade5-hydroxytryptamine receptor 2BHomo sapiens (human)
protein kinase C signaling5-hydroxytryptamine receptor 2BHomo sapiens (human)
cellular response to temperature stimulus5-hydroxytryptamine receptor 2BHomo sapiens (human)
G protein-coupled serotonin receptor signaling pathway5-hydroxytryptamine receptor 2BHomo sapiens (human)
G protein-coupled receptor signaling pathway, coupled to cyclic nucleotide second messenger5-hydroxytryptamine receptor 2BHomo sapiens (human)
serotonin receptor signaling pathway5-hydroxytryptamine receptor 2BHomo sapiens (human)
chemical synaptic transmission5-hydroxytryptamine receptor 2BHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Molecular Functions (12)

Processvia Protein(s)Taxonomy
Gq/11-coupled serotonin receptor activity5-hydroxytryptamine receptor 2AHomo sapiens (human)
virus receptor activity5-hydroxytryptamine receptor 2AHomo sapiens (human)
G protein-coupled serotonin receptor activity5-hydroxytryptamine receptor 2AHomo sapiens (human)
protein binding5-hydroxytryptamine receptor 2AHomo sapiens (human)
protein tyrosine kinase activator activity5-hydroxytryptamine receptor 2AHomo sapiens (human)
identical protein binding5-hydroxytryptamine receptor 2AHomo sapiens (human)
protein-containing complex binding5-hydroxytryptamine receptor 2AHomo sapiens (human)
serotonin binding5-hydroxytryptamine receptor 2AHomo sapiens (human)
1-(4-iodo-2,5-dimethoxyphenyl)propan-2-amine binding5-hydroxytryptamine receptor 2AHomo sapiens (human)
neurotransmitter receptor activity5-hydroxytryptamine receptor 2AHomo sapiens (human)
Gq/11-coupled serotonin receptor activity5-hydroxytryptamine receptor 2CHomo sapiens (human)
G protein-coupled serotonin receptor activity5-hydroxytryptamine receptor 2CHomo sapiens (human)
protein binding5-hydroxytryptamine receptor 2CHomo sapiens (human)
identical protein binding5-hydroxytryptamine receptor 2CHomo sapiens (human)
serotonin binding5-hydroxytryptamine receptor 2CHomo sapiens (human)
1-(4-iodo-2,5-dimethoxyphenyl)propan-2-amine binding5-hydroxytryptamine receptor 2CHomo sapiens (human)
neurotransmitter receptor activity5-hydroxytryptamine receptor 2CHomo sapiens (human)
Gq/11-coupled serotonin receptor activity5-hydroxytryptamine receptor 2BHomo sapiens (human)
G-protein alpha-subunit binding5-hydroxytryptamine receptor 2BHomo sapiens (human)
G protein-coupled serotonin receptor activity5-hydroxytryptamine receptor 2BHomo sapiens (human)
GTPase activator activity5-hydroxytryptamine receptor 2BHomo sapiens (human)
protein binding5-hydroxytryptamine receptor 2BHomo sapiens (human)
serotonin binding5-hydroxytryptamine receptor 2BHomo sapiens (human)
neurotransmitter receptor activity5-hydroxytryptamine receptor 2BHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Ceullar Components (16)

Processvia Protein(s)Taxonomy
neurofilament5-hydroxytryptamine receptor 2AHomo sapiens (human)
plasma membrane5-hydroxytryptamine receptor 2AHomo sapiens (human)
caveola5-hydroxytryptamine receptor 2AHomo sapiens (human)
axon5-hydroxytryptamine receptor 2AHomo sapiens (human)
cytoplasmic vesicle5-hydroxytryptamine receptor 2AHomo sapiens (human)
presynaptic membrane5-hydroxytryptamine receptor 2AHomo sapiens (human)
neuronal cell body5-hydroxytryptamine receptor 2AHomo sapiens (human)
dendritic shaft5-hydroxytryptamine receptor 2AHomo sapiens (human)
postsynaptic membrane5-hydroxytryptamine receptor 2AHomo sapiens (human)
cell body fiber5-hydroxytryptamine receptor 2AHomo sapiens (human)
glutamatergic synapse5-hydroxytryptamine receptor 2AHomo sapiens (human)
G protein-coupled serotonin receptor complex5-hydroxytryptamine receptor 2AHomo sapiens (human)
plasma membrane5-hydroxytryptamine receptor 2AHomo sapiens (human)
dendrite5-hydroxytryptamine receptor 2AHomo sapiens (human)
plasma membrane5-hydroxytryptamine receptor 2CHomo sapiens (human)
synapse5-hydroxytryptamine receptor 2CHomo sapiens (human)
G protein-coupled serotonin receptor complex5-hydroxytryptamine receptor 2CHomo sapiens (human)
plasma membrane5-hydroxytryptamine receptor 2CHomo sapiens (human)
dendrite5-hydroxytryptamine receptor 2CHomo sapiens (human)
nucleoplasm5-hydroxytryptamine receptor 2BHomo sapiens (human)
cytoplasm5-hydroxytryptamine receptor 2BHomo sapiens (human)
plasma membrane5-hydroxytryptamine receptor 2BHomo sapiens (human)
synapse5-hydroxytryptamine receptor 2BHomo sapiens (human)
G protein-coupled serotonin receptor complex5-hydroxytryptamine receptor 2BHomo sapiens (human)
dendrite5-hydroxytryptamine receptor 2BHomo sapiens (human)
plasma membrane5-hydroxytryptamine receptor 2BHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Bioassays (37)

Assay IDTitleYearJournalArticle
AID1296008Cytotoxic Profiling of Annotated Libraries Using Quantitative High-Throughput Screening2020SLAS discovery : advancing life sciences R & D, 01, Volume: 25, Issue:1
Cytotoxic Profiling of Annotated and Diverse Chemical Libraries Using Quantitative High-Throughput Screening.
AID1347091qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SJ-GBM2 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347083qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lassa (LASV) Arenavirus: Viability assay - alamar blue signal for LASV Primary Screen2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1347104qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for RD cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347090qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for DAOY cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1346986P-glycoprotein substrates identified in KB-3-1 adenocarcinoma cell line, qHTS therapeutic library screen2019Molecular pharmacology, 11, Volume: 96, Issue:5
A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID1508630Primary qHTS for small molecule stabilizers of the endoplasmic reticulum resident proteome: Secreted ER Calcium Modulated Protein (SERCaMP) assay2021Cell reports, 04-27, Volume: 35, Issue:4
A target-agnostic screen identifies approved drugs to stabilize the endoplasmic reticulum-resident proteome.
AID1347424RapidFire Mass Spectrometry qHTS Assay for Modulators of WT P53-Induced Phosphatase 1 (WIP1)2019The Journal of biological chemistry, 11-15, Volume: 294, Issue:46
Physiologically relevant orthogonal assays for the discovery of small-molecule modulators of WIP1 phosphatase in high-throughput screens.
AID1347096qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for U-2 OS cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347095qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for NB-EBc1 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347086qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lymphocytic Choriomeningitis Arenaviruses (LCMV): LCMV Primary Screen - GLuc reporter signal2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1346987P-glycoprotein substrates identified in KB-8-5-11 adenocarcinoma cell line, qHTS therapeutic library screen2019Molecular pharmacology, 11, Volume: 96, Issue:5
A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID1347103qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for OHS-50 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID651635Viability Counterscreen for Primary qHTS for Inhibitors of ATXN expression
AID1347108qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh41 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347105qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for MG 63 (6-TG R) cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347101qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for BT-12 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347099qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for NB1643 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347094qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for BT-37 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347097qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Saos-2 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347425Rhodamine-PBP qHTS Assay for Modulators of WT P53-Induced Phosphatase 1 (WIP1)2019The Journal of biological chemistry, 11-15, Volume: 294, Issue:46
Physiologically relevant orthogonal assays for the discovery of small-molecule modulators of WIP1 phosphatase in high-throughput screens.
AID1347092qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for A673 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347100qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for LAN-5 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347098qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SK-N-SH cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347093qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SK-N-MC cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347082qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lassa (LASV) Arenavirus: LASV Primary Screen - GLuc reporter signal2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1745845Primary qHTS for Inhibitors of ATXN expression
AID1347407qHTS to identify inhibitors of the type 1 interferon - major histocompatibility complex class I in skeletal muscle: primary screen against the NCATS Pharmaceutical Collection2020ACS chemical biology, 07-17, Volume: 15, Issue:7
High-Throughput Screening to Identify Inhibitors of the Type I Interferon-Major Histocompatibility Complex Class I Pathway in Skeletal Muscle.
AID1347089qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for TC32 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347106qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for control Hh wild type fibroblast cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347154Primary screen GU AMC qHTS for Zika virus inhibitors2020Proceedings of the National Academy of Sciences of the United States of America, 12-08, Volume: 117, Issue:49
Therapeutic candidates for the Zika virus identified by a high-throughput screen for Zika protease inhibitors.
AID1347107qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh30 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347102qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh18 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1648177Induction of head-twitch response in ip dosed C57BL/6J mouse measured for 20 mins2020Journal of natural products, 02-28, Volume: 83, Issue:2
Synthesis and Biological Evaluation of Tryptamines Found in Hallucinogenic Mushrooms: Norbaeocystin, Baeocystin, Norpsilocin, and Aeruginascin.
AID255671Effective concentration required for accumulation of [3H]inositol phosphate in cells stably expressing human 5-hydroxytryptamine 2C receptor determined by phosphoinositide hydrolysis assay2005Bioorganic & medicinal chemistry letters, Oct-15, Volume: 15, Issue:20
SAR of psilocybin analogs: discovery of a selective 5-HT 2C agonist.
AID255670Effective concentration required for accumulation of [3H]inositol phosphate in cells stably expressing human 5-hydroxytryptamine 2A receptor determined by phosphoinositide hydrolysis assay2005Bioorganic & medicinal chemistry letters, Oct-15, Volume: 15, Issue:20
SAR of psilocybin analogs: discovery of a selective 5-HT 2C agonist.
AID255672Effective concentration required for accumulation of [3H]inositol phosphate in cells transiently expressing human 5-hydroxytryptamine 2B receptor determined by phosphoinositide hydrolysis assay2005Bioorganic & medicinal chemistry letters, Oct-15, Volume: 15, Issue:20
SAR of psilocybin analogs: discovery of a selective 5-HT 2C agonist.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (1,082)

TimeframeStudies, This Drug (%)All Drugs %
pre-1990369 (34.10)18.7374
1990's32 (2.96)18.2507
2000's71 (6.56)29.6817
2010's191 (17.65)24.3611
2020's419 (38.72)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 103.04

According to the monthly volume, diversity, and competition of internet searches for this compound, as well the volume and growth of publications, there is estimated to be very strong demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index103.04 (24.57)
Research Supply Index7.15 (2.92)
Research Growth Index5.25 (4.65)
Search Engine Demand Index189.88 (26.88)
Search Engine Supply Index2.00 (0.95)

This Compound (103.04)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials105 (8.97%)5.53%
Reviews235 (20.09%)6.00%
Case Studies47 (4.02%)4.05%
Observational6 (0.51%)0.25%
Other777 (66.41%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (137)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Psilocybin-Enhanced Psychotherapy for Methamphetamine Use Disorder [NCT04982796]Phase 1/Phase 230 participants (Anticipated)Interventional2022-07-07Recruiting
Effects of Psilocybin in Anorexia Nervosa [NCT04052568]Phase 122 participants (Actual)Interventional2019-08-26Completed
Psilocybin-assisted Cognitive Behavioral Therapy for Depression [NCT05227612]Early Phase 130 participants (Anticipated)Interventional2023-06-27Enrolling by invitation
PAPR: Psilocybin-assisted Psychotherapy + Mindfulness-Based Stress Reduction (MBSR) for Front-line Healthcare Provider COVID-19 Related Burnout [NCT05557643]Early Phase 124 participants (Anticipated)Interventional2023-01-02Recruiting
Beyond the Self and Back: Neuropharmacological Mechanisms Underlying the Dissolution of the Self [NCT03736980]140 participants (Actual)Interventional2013-10-01Completed
Psilocybin for Treatment of Obsessive Compulsive Disorder [NCT03300947]Phase 115 participants (Anticipated)Interventional2019-01-02Active, not recruiting
Direct Comparison of Altered States of Consciousness Induced by LSD and Psilocybin in a Random-order Placebo-controlled Cross-over Study in Healthy Subjects [NCT03604744]Early Phase 128 participants (Actual)Interventional2019-03-27Completed
Psilocybin-facilitated Treatment for Chronic Pain [NCT05068791]Early Phase 130 participants (Anticipated)Interventional2023-11-01Recruiting
An Open Label Pragmatic Feasibility Study on a Resilience Focused Community of Practice Program With Psilocybin-assisted Therapy (PaT) for End-of-Life Patients. [NCT05958758]Early Phase 164 participants (Anticipated)Interventional2023-09-01Not yet recruiting
Evaluating the Effect of Length of Time on Selective Serotonin Reuptake Inhibitors (SSRIs) on the Response to Psilocybin-assisted Therapy in Individuals With Mild-moderate Major Depressive Disorder (MDD) [NCT05594667]Phase 20 participants (Actual)Interventional2023-01-01Withdrawn(stopped due to Funding)
Psilocybin for Treatment of Alcohol Use Disorder: a Feasibility Study [NCT04718792]Phase 210 participants (Actual)Interventional2023-02-09Active, not recruiting
Consciousness and Psilocybin Effects on Well-Being (The CoPE Study): Pilot Phase [NCT05592379]Phase 115 participants (Anticipated)Interventional2023-11-07Enrolling by invitation
Effects of Psilocybin and Spiritual Practice on Persisting Changes in Attitudes and Behavior [NCT00802282]Phase 175 participants (Actual)Interventional2009-08-31Completed
Psilocybin-Assisted vs Ketamine-Assisted Psychotherapy for Alcohol Use Disorder [NCT05421065]Phase 220 participants (Anticipated)Interventional2024-01-31Not yet recruiting
Precision Functional Brain Mapping to Understand the Mechanisms of Psilocybin [NCT04501653]Early Phase 125 participants (Anticipated)Interventional2021-06-01Active, not recruiting
A Phase III, Multicentre, Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy, Safety, and Tolerability of COMP360 in Participants With Treatment-resistant Depression [NCT05624268]Phase 3255 participants (Anticipated)Interventional2023-01-19Recruiting
Psilocybin vs Escitalopram for Major Depressive Disorder: Comparative Mechanisms [NCT03429075]Phase 259 participants (Actual)Interventional2019-01-07Active, not recruiting
Psilocybin Versus Ketamine - Fast Acting Antidepressant Strategies in Treatment-resistant Depression [NCT05383313]Phase 260 participants (Anticipated)Interventional2021-05-01Recruiting
Does Psilocybin Change Synaptic Density in the Brains of Patients With Amnestic Mild Cognitive Impairment [NCT06041152]Phase 260 participants (Anticipated)Interventional2023-09-30Not yet recruiting
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of up to Two Doses of Psilocybin for the Treatment of Major Depressive Disorder in Adults With Cancer [NCT05947383]Phase 256 participants (Anticipated)Interventional2023-07-07Recruiting
Measurement of Persisting Changes in Emotional Brain Functioning Produced by Psilocybin [NCT02971605]Phase 1/Phase 213 participants (Actual)Interventional2017-07-01Completed
Exploration of Synaptotrophic Effects of Psilocybin in Opioid Use Disorder (OUD) [NCT06160284]Phase 112 participants (Anticipated)Interventional2024-01-31Not yet recruiting
Psilocybin-Assisted Therapy for Severe Alcohol Use Disorder: Feasibility, Clinical Efficacy & (Neuro)Cognitive Mechanisms [NCT06160232]Phase 262 participants (Anticipated)Interventional2024-01-15Not yet recruiting
Does Serotonin System Stimulation Increase Pro-social Behavior? - A Comparative Pharmacological Neuroscientific Study in Healthy Humans [NCT06081179]Phase 1120 participants (Anticipated)Interventional2023-10-24Recruiting
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Efficacy of Psilocybin-Assisted Psychotherapy in Treating Severe Depression Among Adults With Post-Traumatic Stress Disorder (PTSD). [NCT06141876]Phase 2160 participants (Anticipated)Interventional2023-12-15Not yet recruiting
Outpatient Buprenorphine Induction With Psilocybin for Opioid Use Disorder: a Randomized Double-blind Trial [NCT06067737]Phase 290 participants (Anticipated)Interventional2023-12-31Not yet recruiting
Microdosing Psychedelics to Improve Mood [NCT05259943]Phase 250 participants (Anticipated)Interventional2023-07-15Recruiting
The Effects of Psilocybin on Self-Focus and Self-Related Processing in Treatment Resistant MDD [NCT05381974]Phase 220 participants (Anticipated)Interventional2022-09-15Recruiting
The Safety, Feasibility, and Acceptability of Psilocybin Combined With Multidisciplinary Palliative Care in Demoralized Cancer Survivors With Chronic Pain (P-PC) [NCT05506982]Phase 110 participants (Anticipated)Interventional2022-11-01Recruiting
A Phase 1/2 Study of a Group Model of Psilocybin-Assisted Therapy for Cancer-Related Anxiety in Patients With Metastatic Cancer [NCT05847686]Phase 1/Phase 256 participants (Anticipated)Interventional2023-06-27Recruiting
Pragmatic Trial of Psilocybin Therapy in Palliative Care (PT2PC): A Multicenter Triple-blind Phase 2 Randomized Controlled Trial of Psilocybin Therapy for Demoralized Adults Near the End of Life [NCT05403086]Phase 2100 participants (Anticipated)Interventional2024-01-14Not yet recruiting
Double-blind Placebo-controlled Naturalistic Study of Microdosing With Psilocybin: Effects on Brain Activity, Behavior, Cognition, Creativity, and Mental Health [NCT05160220]34 participants (Actual)Interventional2021-01-20Completed
A Double-Blind Trial of Psilocybin-Assisted Treatment of Alcohol Dependence [NCT02061293]Phase 295 participants (Actual)Interventional2014-06-30Completed
Probing the Functional Magnetic Resonance Imaging Response to Psilocybin in Functional Neurological Disorder (PsiFUND) [NCT05723276]24 participants (Anticipated)Interventional2024-01-31Not yet recruiting
An Exploratory Pilot Study of Palliadelic Treatment to Reduce Psychological Distress and Improve Quality of Life in Persons With Pancreatobiliary Cancer, With a Parallel Assessment of Healthcare Utilization and Family Wellbeing [NCT05220046]Phase 124 participants (Anticipated)Interventional2023-04-10Recruiting
Effects and Therapeutic Potential of Psilocybin in Alcohol Dependence [NCT01534494]Phase 210 participants (Actual)Interventional2012-01-31Completed
SV2A Marker of Synaptogenesis in a Clinical Trial of Psilocybin for Depression [NCT05601648]Phase 20 participants (Actual)Interventional2023-07-01Withdrawn(stopped due to Due to negative results in similar trials using 11C-UCB-J)
Efficacy and Safety of COMP360 Psilocybin Therapy in Anorexia Nervosa: a Proof-of-concept Study [NCT05481736]Phase 260 participants (Anticipated)Interventional2022-10-12Recruiting
Pharmacokinetics of Psilocybin in Normal Adult Volunteers [NCT02163707]Phase 112 participants (Actual)Interventional2014-06-30Completed
A Phase 1 Study Comparing the Pharmacokinetics and Safety of Intravenous and Oral Psilocybin [NCT05467761]Phase 10 participants (Actual)Interventional2023-06-30Withdrawn(stopped due to Sponsor was not financially able or willing to continue to support the study)
Mechanisms Supporting Psilocybin-assisted Psychotherapy for Alcohol Use Disorder: A Randomized, Controlled Clinical Trial [NCT05995769]Phase 2128 participants (Anticipated)Interventional2024-01-31Not yet recruiting
Phase II, Randomized, Double Blind, Placebo Controlled, Parallel Group, Single Center Study of Psilocybin Efficacy in Major Depression [NCT03715127]Phase 255 participants (Actual)Interventional2019-03-11Completed
Acute Effects of 2C-B Compared With MDMA and Psilocybin in Healthy Subjects [NCT05523401]Phase 124 participants (Anticipated)Interventional2023-06-30Not yet recruiting
Effects of Psilocybin on Behavior, Psychology and Brain Function in Long-term Meditators [NCT02145091]Phase 140 participants (Actual)Interventional2014-05-31Completed
Safety and Efficacy of Psilocybin for the Treatment of Headache Disorders [NCT02981173]Phase 125 participants (Actual)Interventional2016-12-05Completed
Examining the Safety and Clinical Efficacy of Psilocybin Therapy for Veterans With PTSD: An Open-Label Proof-of-Concept Trial [NCT05554094]Phase 215 participants (Anticipated)Interventional2023-01-01Recruiting
Does Psilocybin Require Psychedelic Effects to Treat Depression? A 4-Week, Double-Blind, Proof-of-Concept Randomized Controlled Trial [NCT05710237]Phase 260 participants (Anticipated)Interventional2023-07-01Recruiting
The QUANTUM Trip Trial - Psilocybin-assisted Therapy for Reducing Alcohol Intake in Patients With Alcohol Use Disorder: A Randomized, Double-blinded, Placebo-controlled Clinical Trial. [NCT05416229]Phase 290 participants (Anticipated)Interventional2023-09-01Recruiting
Assessing the Safety, Tolerability, and Efficacy of Psilocybin Therapy Followed by Accelerated Intermittent Theta Burst (aiTBS) Repetitive Transcranial Magnetic Stimulation (rTMS) for Treatment-Resistant Major Depressive Disorder [NCT06132178]Phase 2100 participants (Anticipated)Interventional2024-01-01Not yet recruiting
A Randomized, Double-Blind, Support-of-Concept Phase 2 Study of Single-Dose Psilocybin for Major Depressive Disorder (MDD) [NCT03866174]Phase 2104 participants (Actual)Interventional2019-10-15Completed
An Open Label Study of the Safety and Efficacy of Psilocybin in Participants With Treatment-Resistant Depression (P-TRD) [NCT04433858]Phase 227 participants (Actual)Interventional2021-03-01Active, not recruiting
Effects of Psilocybin in Advanced-Stage Cancer Patients With Anxiety [NCT00302744]Phase 1/Phase 212 participants (Actual)Interventional2004-04-30Completed
An Open-Label Investigation of the Effects of Sub-Perceptual Repeat Dosing of Psilocybin on the Behavioural and Cognitive Symptoms of Fragile X Syndrome in Adult Patients [NCT05832255]Phase 210 participants (Anticipated)Interventional2023-03-28Recruiting
A Phase III, Multicentre, Randomised, Double-blind, Controlled Study to Investigate the Efficacy, Safety, and Tolerability of Two Administrations of COMP360 in Participants With Treatment-resistant Depression [NCT05711940]Phase 3568 participants (Anticipated)Interventional2023-02-14Recruiting
Investigating the Mechanisms of the Effects of Psilocybin on Visual Perception and Visual Representations in the Brain [NCT05265546]Phase 180 participants (Anticipated)Interventional2024-02-14Not yet recruiting
An Open Label Study of Single-Dose Psilocybin for Major Depressive Disorder With Co-occurring Borderline Personality Disorder [NCT05399498]Phase 210 participants (Anticipated)Interventional2023-10-01Not yet recruiting
Safety and Tolerability of Psilocybin in Post-Traumatic Stress Disorder [NCT05562973]Phase 130 participants (Anticipated)Interventional2024-02-29Not yet recruiting
Psilocybin Treatment of Major Depressive Disorder With Co-occurring Alcohol Use Disorder [NCT04620759]Phase 290 participants (Anticipated)Interventional2021-04-14Recruiting
An Open-Label Pilot Study Examining the Feasibility, Safety, and Effectiveness of Psilocybin Therapy for Depression in Bipolar II Disorder [NCT05065294]Phase 214 participants (Anticipated)Interventional2022-01-28Recruiting
Comparison of the Effects of PEX20 (Oral Psilocin), PEX30 (Sublingual Psilocin), and PEX10 (Oral Psilocybin) in Healthy Adults [NCT05317689]Phase 120 participants (Anticipated)Interventional2022-05-26Recruiting
A Pilot Study of Psilocybin Enhanced Group Psychotherapy in Patients With Cancer [NCT04522804]Early Phase 112 participants (Actual)Interventional2021-10-04Active, not recruiting
An Exploratory Open-Label, Phase 1b, Ascending Dose Study to Evaluate the Effects of Oral 3-[2-(Dimethylamino)Ethyl]-1h-indol-4-yl Dihydrogen Phosphate (Psilocybin, BPL-PSILO) on Cognition in Patients With Chronic Short-Lasting Unilateral Neuralgiform Hea [NCT04905121]Phase 14 participants (Actual)Interventional2021-08-11Terminated(stopped due to Unable to recruit patient population)
Behavioral and Neural Mechanisms Supporting Psilocybin-assisted Therapy for Phantom Limb Pain [NCT05224336]Phase 120 participants (Anticipated)Interventional2022-01-01Recruiting
Evaluation of the Acceptability, Safety, Feasibility, and Efficacy of Psilocybin-assisted Psychotherapy (PaP) for the Treatment of Post-traumatic Stress Disorder (PTSD) in Military Veterans [NCT05876481]Phase 28 participants (Anticipated)Interventional2023-06-30Not yet recruiting
5-HT2A Agonist Psilocybin in the Treatment of Tobacco Use Disorder [NCT05452772]Phase 266 participants (Anticipated)Interventional2023-11-01Recruiting
Pilot Study: Effects of Psilocybin on Behavior, Psychology and Brain Function in Long-term Meditators [NCT01988311]Phase 110 participants (Anticipated)Interventional2013-05-31Completed
A Randomized, Double-Blind Study of Psilocybin for Opioid Use Disorder in Patients on Methadone Maintenance With Ongoing Opioid Use [NCT05242029]Phase 292 participants (Anticipated)Interventional2023-12-31Not yet recruiting
Phase II, Randomized, Double Blind, Placebo Controlled, Parallel Group, Single Center Study of Psilocybin Efficacy and Mechanism in Alcohol Use Disorder [NCT04141501]Phase 237 participants (Actual)Interventional2020-06-08Completed
A Phase 2a, Open-label, Pilot Study to Assess the Safety and Efficacy of Psilocybin Administration in Concert With Psychotherapy Among Adult Patients With Fibromyalgia [NCT05128162]Phase 210 participants (Anticipated)Interventional2023-09-27Recruiting
Repeat Dosing of Psilocybin in Headache Disorders [NCT04218539]Phase 124 participants (Anticipated)Interventional2021-08-10Active, not recruiting
Safety and Efficacy of Psilocybin for the Treatment of Headache Disorders: Sub-Study II [NCT03806985]Phase 112 participants (Actual)Interventional2019-03-28Terminated(stopped due to Challenging to recruit qualifying subjects)
Safety and Efficacy of Psilocybin for the Treatment of Headache Disorders: Sub-Study I [NCT03341689]Phase 114 participants (Actual)Interventional2017-11-01Completed
Phase I Study of the Safety and Adjunctive Effects of Psilocybin in Adults With Opioid Use Disorder Maintained on a Buprenorphine/Naloxone Formulation [NCT04161066]Phase 110 participants (Anticipated)Interventional2021-01-13Recruiting
Inpatient Buprenorphine Induction With Psilocybin for Opioid Use Disorder: a Randomized Double-blind Trial [NCT06005662]Phase 290 participants (Anticipated)Interventional2023-12-31Recruiting
A Phase 2a Safety and Feasibility Study Evaluating Psilocybin (TRP-8802) Administration in Concert With Psychotherapy in the Treatment of Binge Eating Disorder [NCT05035927]Phase 210 participants (Anticipated)Interventional2022-03-16Active, not recruiting
A 24-Week, Multicentre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Clinical Trial to Evaluate Efficacy and Safety of Psilocybin-Assisted Psychotherapy in Adults With Alcohol Use Disorder (AUD) [NCT05646303]Phase 2128 participants (Anticipated)Interventional2022-05-02Recruiting
NW Trauma Therapies, Chronic Illness of Chronic Depression, PTSD, MS, HIV, and SARS-CoV-2, Long Haulers Syndrome. Treatment of Unregulaaible Trauma by the Treatment of Enhanced Micro Dosing the Levels of 0.15, Thru 0.33, With a Maintenance Dose of 1 Gram [NCT05042466]Phase 130 participants (Anticipated)Interventional2023-09-03Not yet recruiting
Standardized Natural Psilocybin-assisted Psychotherapy for Tapering of Opioid Medication in Patients With Chronic Pain: an Open-label Feasibility Study [NCT05585229]Phase 210 participants (Anticipated)Interventional2023-11-01Not yet recruiting
The Neurobiological Effect of 5-HT2AR Modulation [NCT03289949]Phase 1200 participants (Anticipated)Interventional2017-03-03Recruiting
A Randomised, Placebo Controlled Trial of Psilocybin in Treatment Resistant Depression: A Feasibility Study [NCT04959253]Phase 260 participants (Anticipated)Interventional2020-09-01Recruiting
Comparative Acute Effects of LSD, Psilocybin and Mescaline in a Random-Order Placebo-Controlled Cross-Over Study in Healthy Subjects [NCT04227756]Phase 130 participants (Anticipated)Interventional2020-05-19Active, not recruiting
Psilocybin as a Treatment for Anorexia Nervosa: A Pilot Study [NCT04505189]Phase 1/Phase 221 participants (Actual)Interventional2021-05-28Active, not recruiting
Pilot Trial of Visual Healing®, a Nature-themed Virtual Immersive Experience, to Optimize Set and Setting in Psilocybin-assisted Therapy for Alcohol Use Disorder [NCT04410913]Phase 220 participants (Actual)Interventional2021-02-18Active, not recruiting
Feasibility Phase 2 Study of Psilocybin-Assisted Therapy for Opioid-Refractory Pain in Patients With Advanced Cancer [NCT06001749]Phase 215 participants (Anticipated)Interventional2024-01-31Not yet recruiting
Exploratory Study of the Effects of Low-Dose Psilocybin on Sensory Processing, Neurophysiological Arousal, and Emotional Health [NCT05227742]Early Phase 160 participants (Anticipated)Interventional2023-08-15Recruiting
Psilocybin-facilitated Treatment for Cocaine Use: A Pilot Study [NCT02037126]Phase 240 participants (Actual)Interventional2015-05-31Active, not recruiting
A Phase II Randomized, Double-blind, Active Placebo-controlled Parallel Group Trial to Examine the Efficacy and Safety of Psilocybin in Treatment-resistant Major Depression [NCT04670081]Phase 2144 participants (Actual)Interventional2021-06-10Active, not recruiting
Psilocybin Therapy for Depression and Anxiety in Parkinson's Disease: a Pilot Study [NCT04932434]Phase 210 participants (Anticipated)Interventional2021-08-15Active, not recruiting
Psilocybin-assisted Psychotherapy in the Management of Anxiety Associated With Stage IV Melanoma. [NCT00979693]Phase 20 participants (Actual)Interventional2012-01-31Withdrawn(stopped due to "The study was suspended because the PI was unable to get permission from his department to submit the protocol to the local IRB?")
Psilocybin-assisted Interpersonal Therapy for Depression [NCT05581797]20 participants (Anticipated)Interventional2023-03-15Enrolling by invitation
Safety and Efficacy of Psilocybin for Body Dysmorphic Disorder [NCT04656301]Phase 212 participants (Actual)Interventional2021-02-26Completed
A Phase 2b, Randomized, Double-blind, Placebo-controlled, Multi-center Study of the Effects of Psilocybin-assisted Psychotherapy on Psychiatric and Existential Distress in Advanced Cancer [NCT05398484]Phase 2/Phase 3300 participants (Anticipated)Interventional2023-06-15Recruiting
The Safety and Efficacy of Psilocybin in Patients With Treatment-resistant Depression and Chronic Suicidal Ideation [NCT05220410]Phase 220 participants (Anticipated)Interventional2022-03-28Recruiting
Effects of Psilocybin in Obsessive Compulsive Disorder [NCT05546658]Early Phase 130 participants (Anticipated)Interventional2022-11-28Recruiting
Evaluation of Psilocybin in Anorexia Nervosa: Safety and Efficacy [NCT04661514]Phase 216 participants (Actual)Interventional2021-05-01Completed
Psychopharmacology of Psilocybin in Cancer Patients [NCT00465595]Phase 256 participants (Actual)Interventional2007-04-30Completed
Multivariate Neural and Physiological Correlates of Psychedelic Sub-states: a Within-subjects, Healthy Volunteer Study With Experience-sampling [NCT05698511]Phase 112 participants (Anticipated)Interventional2023-07-31Recruiting
The Safety and Tolerability of COMP360 in Participants With Post-traumatic Stress Disorder [NCT05312151]Phase 220 participants (Anticipated)Interventional2022-06-10Recruiting
A Double-blind, Randomized Trial Examining the Preliminary Efficacy of Psilocybin Therapy for People With Chronic Low Back Pain [NCT05351541]Phase 1/Phase 230 participants (Anticipated)Interventional2023-12-01Recruiting
Prophylactic Effects of Psilocybin on Chronic Cluster Headache: an Open-label Clinical Trial and Neuroimaging Study [NCT04280055]Phase 1/Phase 210 participants (Actual)Interventional2020-01-21Terminated(stopped due to Not possible to achieve the anticipated no. of patients due to Covid-19 pandemic)
Psilocybin-assisted Group Therapy for Demoralization in Long-term AIDS Survivors [NCT02950467]Phase 130 participants (Actual)Interventional2018-01-05Completed
A Phase 1, Two-Part Study in Healthy Volunteers to Evaluate The Effect of Psilocybin on Cardiac Repolarization and The Effect of Food on Psilocybin Pharmacokinetics [NCT05478278]Phase 160 participants (Actual)Interventional2022-06-22Completed
Psilocybin-facilitated Smoking Cessation Treatment: A Pilot Study [NCT01943994]95 participants (Anticipated)Interventional2008-09-30Active, not recruiting
The Efficacy and Tolerability of Psilocybin in Participants With Treatment-Resistant Depression: a Phase 2, Randomized Feasibility Study [NCT05029466]Phase 230 participants (Actual)Interventional2021-11-19Completed
Engaging Mood Brain Circuits With Psilocybin: a Randomized Neuroimaging Trial in Depression [NCT06072898]Phase 250 participants (Anticipated)Interventional2023-12-31Not yet recruiting
The Safety and Efficacy of Psilocybin in Participants With Type 2 Bipolar Disorder (BP-II) Depression. [NCT04433845]Phase 215 participants (Actual)Interventional2021-03-01Active, not recruiting
Effects of Psilocybin in Major Depressive Disorder [NCT03181529]Phase 227 participants (Actual)Interventional2017-08-10Completed
"Mood and Cognitive Effects of Low Doses of Psilocybin Observed in Healthy Subjects (MELO): A Blinded, Placebo-Controlled, Dose-Finding Study" [NCT05252598]Early Phase 10 participants (Actual)Interventional2023-01-31Withdrawn(stopped due to The sponsor no longer wishes to pursue the methods outlined in the protocol.)
Safety and Feasibility of Psilocybin in Methamphetamine Use Disorder in a Community-Based Sample [NCT05322954]Phase 112 participants (Anticipated)Interventional2023-03-03Recruiting
A Randomized, Placebo-controlled Trial of Psychedelic-assisted Psychotherapy With Single Dose Psilocybin for Frontline Clinicians Experiencing COVID-related Symptoms of Depression and Burnout [NCT05163496]Phase 330 participants (Actual)Interventional2022-03-03Active, not recruiting
Recall of Experience and Conscious Awareness in Psilocybin Treatment of Depression (The RECAP Study): Pilot Phase in Healthy Adult Volunteers [NCT04842045]Phase 18 participants (Actual)Interventional2021-05-21Completed
Psilocybin Treatment in Obsessive-Compulsive Disorder: a Preliminary Efficacy Study and Exploratory Investigation of Neural Correlates. [NCT03356483]Phase 130 participants (Anticipated)Interventional2018-11-13Recruiting
Effects of Psilocybin on Anxiety and Psychosocial Distress in Cancer Patients [NCT00957359]Early Phase 129 participants (Actual)Interventional2009-02-28Completed
Open Label, Phase 1 Study for Evaluating the Feasibility, Safety and Efficacy of Psychotherapy Assisted Psilocybin for Treatment of Severe OCD [NCT04882839]Phase 1/Phase 215 participants (Anticipated)Interventional2023-05-01Not yet recruiting
The Effect of Psilocybin on MDD Symptom Severity and Synaptic Density - A Single Dose Randomized, Double Blind, Placebo- Controlled Phase 2 Positron Emission Tomography Study [NCT04630964]Phase 235 participants (Actual)Interventional2021-01-01Active, not recruiting
The Role of Personal Experience for the Therapeutic Attitude in the Context of Substance-assisted Therapy Training [NCT05570708]48 participants (Anticipated)Interventional2022-10-25Enrolling by invitation
Effects of Psilocybin in Post-Treatment Lyme Disease [NCT05305105]Phase 120 participants (Anticipated)Interventional2022-07-01Enrolling by invitation
Effects of Psilocybin on Electrophysiology and the Dynamic Content of Thought [NCT05301608]Phase 1/Phase 230 participants (Anticipated)Interventional2022-03-03Recruiting
Pilot Study of Serotonin 2A Receptor (5-HT2A) Agonist Psilocybin for Depression in Patients With Mild Cognitive Impairment or Early Alzheimer's Disease [NCT04123314]Early Phase 120 participants (Anticipated)Interventional2021-03-24Recruiting
Investigating the Therapeutic Effects of Psilocybin in Treatment-Resistant Post-Traumatic Stress Disorder [NCT05243329]Phase 220 participants (Anticipated)Interventional2022-10-03Active, not recruiting
Psilocybin for the Treatment of Major Depressive Disorder [NCT05675800]Phase 235 participants (Anticipated)Interventional2024-01-01Not yet recruiting
Safety Profile of 25 mg Psilocybin in Individuals With Cocaine Use Disorder [NCT06102434]Early Phase 110 participants (Anticipated)Interventional2024-02-29Not yet recruiting
Visual Surround Suppression and Perceptual Expectation Under Psilocybin [NCT04424225]Phase 175 participants (Anticipated)Interventional2021-08-30Recruiting
The Safety and Efficacy of Psilocybin in Cancer Patients With Major Depressive Disorder [NCT04593563]Phase 230 participants (Actual)Interventional2020-09-01Active, not recruiting
Effects of Psilocybin-facilitated Experience on the Psychology and Effectiveness of Professional Leaders in Religion [NCT02243813]Phase 120 participants (Anticipated)Interventional2015-03-31Active, not recruiting
Psilocybin in Patients With Fibromyalgia: EEG-measured Brain Biomarkers of Action [NCT05548075]20 participants (Anticipated)Observational2022-08-15Recruiting
Pilot Study of Psilocybin-Assisted Therapy for Demoralization in Patients Receiving Hospice Care - PATH Study [NCT04950608]Phase 215 participants (Anticipated)Interventional2022-03-09Recruiting
Psilocybin - Induced Neuroplasticity in the Treatment of Major Depressive Disorder [NCT03554174]Phase 118 participants (Anticipated)Interventional2018-02-27Active, not recruiting
A Randomized Controlled Trial of the Effects of Psilocybin-Facilitated Experience on the Psychology and Effectiveness of Professional Leaders in Religion [NCT02421263]Phase 112 participants (Actual)Interventional2015-04-30Completed
Activating Neuroplasticity to ENHANCE the Perception Box Expanding Effects of Psilocybin [NCT05866471]Phase 1100 participants (Anticipated)Interventional2024-03-31Not yet recruiting
The Safety and Efficacy Of Psilocybin as an Adjunctive Therapy in Participants With Treatment Resistant Depression [NCT04739865]Phase 219 participants (Actual)Interventional2020-08-10Completed
Psilocybin and Depression - Assessing the Long-term Effects of a Single Administration of Psilocybin on the Psychiatric Symptoms and Brain Activity of Patients With Severe Depression [NCT03380442]Phase 260 participants (Anticipated)Interventional2018-09-30Not yet recruiting
A Phase II, Multicentre, Randomised, Double-blind, Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of COMP360 in Participants With Major Depressive Disorder With One Prior Treatment Failure [NCT05733546]Phase 2102 participants (Anticipated)Interventional2023-01-30Recruiting
The Safety and Efficacy of Psilocybin in Participants With Treatment Resistant Depression [NCT03775200]Phase 2233 participants (Actual)Interventional2019-03-01Completed
Psilocybin for Psychological and Existential Distress in Palliative Care: A Multi-site, Open-label, Single Arm Phase 1/2 Proof-of-concept, Dose-finding, and Feasibility Clinical Trial [NCT04754061]Phase 1/Phase 240 participants (Anticipated)Interventional2022-03-31Not yet recruiting
Effects of Repeated Dosing of Psilocybin on Obsessive-Compulsive Disorder: A Randomized, Waitlist-Controlled Study [NCT05370911]Phase 130 participants (Anticipated)Interventional2023-07-20Recruiting
Modulation of Serotonin Pathways Using Psilocybin in Adults With and Without Autism Spectrum Disorder (ASD) [NCT05651126]70 participants (Anticipated)Interventional2022-12-31Recruiting
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00465595 (2) [back to overview]GRID-HAM-D-17 -- Structured Interview Guide for the Hamilton Depression Scale.
NCT00465595 (2) [back to overview]HAM-A Assessed With the SIGH-A -- a Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A).
NCT00957359 (54) [back to overview]Death Anxiety Scale
NCT00957359 (54) [back to overview]Death Anxiety Scale
NCT00957359 (54) [back to overview]STAI Trait
NCT00957359 (54) [back to overview]Death Transcendence Scale
NCT00957359 (54) [back to overview]Death Transcendence Scale
NCT00957359 (54) [back to overview]Demoralization Scale
NCT00957359 (54) [back to overview]Demoralization Scale
NCT00957359 (54) [back to overview]Demoralization Scale
NCT00957359 (54) [back to overview]HADS Anxiety
NCT00957359 (54) [back to overview]HADS Anxiety
NCT00957359 (54) [back to overview]HADS Anxiety
NCT00957359 (54) [back to overview]HADS Anxiety
NCT00957359 (54) [back to overview]HADS Anxiety
NCT00957359 (54) [back to overview]HADS Depression
NCT00957359 (54) [back to overview]HADS Anxiety
NCT00957359 (54) [back to overview]HADS Anxiety
NCT00957359 (54) [back to overview]HADS Anxiety
NCT00957359 (54) [back to overview]HADS Depression
NCT00957359 (54) [back to overview]HADS Depression
NCT00957359 (54) [back to overview]HADS Depression
NCT00957359 (54) [back to overview]HADS Depression
NCT00957359 (54) [back to overview]HADS Depression
NCT00957359 (54) [back to overview]HADS Depression
NCT00957359 (54) [back to overview]Hopelessness
NCT00957359 (54) [back to overview]Hopelessness
NCT00957359 (54) [back to overview]Hopelessness
NCT00957359 (54) [back to overview]QoL Environment Scale
NCT00957359 (54) [back to overview]QoL Environment Scale
NCT00957359 (54) [back to overview]QoL Environment Scale
NCT00957359 (54) [back to overview]QoL Physical Health Scale
NCT00957359 (54) [back to overview]QoL Physical Health Scale
NCT00957359 (54) [back to overview]QoL Physical Health Scale
NCT00957359 (54) [back to overview]QoL Psychological Scale
NCT00957359 (54) [back to overview]QoL Psychological Scale
NCT00957359 (54) [back to overview]QoL Psychological Scale
NCT00957359 (54) [back to overview]QoL Social Relationships Scale
NCT00957359 (54) [back to overview]QoL Social Relationships Scale
NCT00957359 (54) [back to overview]QoL Social Relationships Scale
NCT00957359 (54) [back to overview]STAI State
NCT00957359 (54) [back to overview]STAI State
NCT00957359 (54) [back to overview]STAI State
NCT00957359 (54) [back to overview]STAI State
NCT00957359 (54) [back to overview]Death Anxiety Scale
NCT00957359 (54) [back to overview]STAI State
NCT00957359 (54) [back to overview]STAI State
NCT00957359 (54) [back to overview]STAI State
NCT00957359 (54) [back to overview]STAI Trait
NCT00957359 (54) [back to overview]STAI Trait
NCT00957359 (54) [back to overview]STAI Trait
NCT00957359 (54) [back to overview]STAI Trait
NCT00957359 (54) [back to overview]STAI Trait
NCT00957359 (54) [back to overview]STAI Trait
NCT00957359 (54) [back to overview]STAI Trait
NCT00957359 (54) [back to overview]State-Trait Anxiety Inventory (STAI) State
NCT01534494 (1) [back to overview]Change in Percent Heavy Drinking Days
NCT02061293 (21) [back to overview]Percent of Drinking Days
NCT02061293 (21) [back to overview]Short Inventory of Problems (SIP-2R) Score
NCT02061293 (21) [back to overview]Short Inventory of Problems (SIP-2R) Score
NCT02061293 (21) [back to overview]Drinks Per Day
NCT02061293 (21) [back to overview]Drinks Per Day
NCT02061293 (21) [back to overview]Drinks Per Day
NCT02061293 (21) [back to overview]Percent of Participants Achieving WHO Risk Drinking Level Decrease of at Least 1 Level
NCT02061293 (21) [back to overview]Percent of Drinking Days
NCT02061293 (21) [back to overview]Percent of Drinking Days
NCT02061293 (21) [back to overview]Percent of Heavy Drinking Days
NCT02061293 (21) [back to overview]Percent of Heavy Drinking Days
NCT02061293 (21) [back to overview]Percent of Heavy Drinking Days
NCT02061293 (21) [back to overview]Percent of Participants Achieving No Heavy Drinking Days
NCT02061293 (21) [back to overview]Percent of Participants Achieving No Heavy Drinking Days
NCT02061293 (21) [back to overview]Percent of Participants Achieving WHO Risk Drinking Level Decrease of at Least 1 Level
NCT02061293 (21) [back to overview]Percent of Participants Achieving WHO Risk Drinking Level Decrease of at Least 2 Levels
NCT02061293 (21) [back to overview]Percent of Participants Achieving WHO Risk Drinking Level Decrease of at Least 2 Levels
NCT02061293 (21) [back to overview]Percent of Participants Achieving WHO Risk Drinking Level Decrease of at Least 3 Levels
NCT02061293 (21) [back to overview]Percent of Participants Achieving WHO Risk Drinking Level Decrease of at Least 3 Levels
NCT02061293 (21) [back to overview]Percentage of Participants Achieving Abstinence From Drinking
NCT02061293 (21) [back to overview]Percentage of Participants Achieving Abstinence From Drinking
NCT02950467 (25) [back to overview]Change From Baseline in State-Trait Anxiety Inventory (Trait) at End-of-treatment
NCT02950467 (25) [back to overview]Number of Participants Who Experienced Treatment-related Adverse Events as Assessed by NIH Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.0
NCT02950467 (25) [back to overview]Change in Average Score on Subscales of Group Questionnaire Pre-drug vs Post-drug
NCT02950467 (25) [back to overview]Subject Recruitment and Retention
NCT02950467 (25) [back to overview]Change From Baseline in McGill Quality of Life Questionnaire-Revised (Overall) at 3-month Follow-up
NCT02950467 (25) [back to overview]Change From Baseline in Antiretroviral Medication Adherence Scale at 3-month Follow-up
NCT02950467 (25) [back to overview]Change From Baseline in Antiretroviral Medication Adherence Scale at End-of-treatment
NCT02950467 (25) [back to overview]Change From Baseline in Center for Epidemiologic Studies Depression Scale-Revised at 3-month Follow-up
NCT02950467 (25) [back to overview]Change From Baseline in Center for Epidemiologic Studies Depression Scale-Revised at End-of-treatment
NCT02950467 (25) [back to overview]Change From Baseline in Demoralization Scale-II at 3-month Follow-up
NCT02950467 (25) [back to overview]Change From Baseline in Demoralization Scale-II at End-of-treatment
NCT02950467 (25) [back to overview]Change From Baseline in Experiences in Closer Relationships-M16 (Anxiety) at 3-month Follow-up
NCT02950467 (25) [back to overview]Change From Baseline in Experiences in Closer Relationships-M16 (Anxiety) at End-of-treatment
NCT02950467 (25) [back to overview]Change From Baseline in Experiences in Closer Relationships-M16 (Avoidance) at 3-month Follow-up
NCT02950467 (25) [back to overview]Change From Baseline in Experiences in Closer Relationships-M16 (Avoidance) at End-of-treatment
NCT02950467 (25) [back to overview]Change From Baseline in HIV and Abuse Related Shame Inventory at 3-month Follow-up
NCT02950467 (25) [back to overview]Change From Baseline in HIV and Abuse Related Shame Inventory at End-of-treatment
NCT02950467 (25) [back to overview]Change From Baseline in Inventory of Complicated Grief at 3-month Follow-up
NCT02950467 (25) [back to overview]Change From Baseline in Inventory of Complicated Grief-Revised at End-of-treatment
NCT02950467 (25) [back to overview]Change From Baseline in McGill Quality of Life Questionnaired-Revised (Overall) at End-of-treatment
NCT02950467 (25) [back to overview]Change From Baseline in PTSD Checklist 5 at 3-month Follow-up
NCT02950467 (25) [back to overview]Change From Baseline in PTSD Checklist 5 at End-of-treatment
NCT02950467 (25) [back to overview]Change From Baseline in State-Trait Anxiety Inventory (State) at 3-month Follow-up
NCT02950467 (25) [back to overview]Change From Baseline in State-Trait Anxiety Inventory (State) at End-of-treatment
NCT02950467 (25) [back to overview]Change From Baseline in State-Trait Anxiety Inventory (Trait) at 3-month Follow-up
NCT02971605 (5) [back to overview]Change in Emotional Functioning Tasks Response Time (Milliseconds)
NCT02971605 (5) [back to overview]Change in Longitudinal Emotion and Mood Questionnaire Scores
NCT02971605 (5) [back to overview]Change in Longitudinal Emotion and Mood Questionnaire Scores
NCT02971605 (5) [back to overview]Change in Emotional Functioning Task Accuracy
NCT02971605 (5) [back to overview]Amygdala Response to Stimuli in the Emotion Recognition Test
NCT03181529 (1) [back to overview]The GRID-Hamilton Depression Rating Scale (GRID-HAMD)
NCT03775200 (2) [back to overview]MADRS Change From Baseline to Week 3, Sensitivity Analysis
NCT03775200 (2) [back to overview]Montgomery Asberg Depression Rating Scale (MADRS) Change From Baseline to Week 3
NCT04656301 (1) [back to overview]Body Dysmorphic Disorder Modification of the Yale-Brown Obsessive Compulsive Disorder Scale
NCT04739865 (4) [back to overview]Improvement in Clinical Global Impression - Severity
NCT04739865 (4) [back to overview]Improvement in Depressive Symptoms
NCT04739865 (4) [back to overview]Incidence of Remission
NCT04739865 (4) [back to overview]Incidence of Response

GRID-HAM-D-17 -- Structured Interview Guide for the Hamilton Depression Scale.

The GRID-Hamilton Depression Rating Scale is a 17-item clinician-administered rating scale designed to assess severity of depressive symptoms. The score range for the GRID-HAMD is 0 to 52, with higher score indicating more severe depression. For this clinician-rated measure, a clinically significant response was defined as ⩾50% decrease in measure relative to Baseline; symptom remission was defined as ⩾50% decrease in measure relative to Baseline and a score of ⩽7 on the GRID-HAMD (NCT00465595)
Timeframe: Baseline, 5 weeks post session 1 and 2, 6-month follow-up

Interventionunits on a scale (Mean)
Low-Dose First Baseline22.32
Low-Dose First Post Session 114.8
Low-Dose First Post Session 26.5
Low-Dose First 6 Month6.95
High-Dose First Baseline22.84
High-Dose First Post Session 16.64
High-Dose First Post Session 26.52
High-Dose First 6 Month6.23

[back to top]

HAM-A Assessed With the SIGH-A -- a Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A).

"The Hamilton Anxiety Rating Scale is a 14-item clinician-administered rating scale designed to assess severity of anxiety symptoms. The score range for the HAM-A is 0 to 56, with higher score indicating more severe anxiety.~For this clinician-rated measure, a clinically significant response was defined as ⩾50% decrease in measure relative to Baseline; symptom remission was defined as ⩾50% decrease in measure relative to Baseline and a score of ⩽7 on the GRID-HAM-A" (NCT00465595)
Timeframe: Baseline, 5 weeks post session 1 and 2, 6-month follow-up

Interventionunits on a scale (Mean)
Low-Dose First Baseline25.68
Low-Dose First Post Session 116.64
Low-Dose First Post Session 28.92
Low-Dose First 6 Month7.95
High-Dose First Baseline25.73
High-Dose First Post Session 18.48
High-Dose First Post Session 27.52
High-Dose First 6 Month7.04

[back to top]

Death Anxiety Scale

0-15 (higher score more death anxiety) (NCT00957359)
Timeframe: 2 weeks post drug administration 1

Interventionscore on a scale (Mean)
Psilocybin First, Then Niacin6.57
Niacin First, Then Psilocybin7.85

[back to top]

Death Anxiety Scale

0-15 (higher score more death anxiety) (NCT00957359)
Timeframe: 2-4 weeks prior to drug administration/ Baseline

Interventionscore on a scale (Mean)
Psilocybin First, Then Niacin9.14
Niacin First, Then Psilocybin8.13

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STAI Trait

"STAI scores 20-80 (higher score more anxiety). Commonly classified as no or low anxiety (20-37), moderate anxiety (38-44), and high anxiety (45-80)." (NCT00957359)
Timeframe: 1 day post drug administration 1

Interventionscore on a scale (Mean)
Psilocybin First, Then Niacin27.5
Niacin First, Then Psilocybin44

[back to top]

Death Transcendence Scale

0-60 (higher score more death transcendence) (NCT00957359)
Timeframe: 2 weeks post drug administration 1

Interventionscore on a scale (Mean)
Psilocybin First, Then Niacin33.98
Niacin First, Then Psilocybin19.88

[back to top]

Death Transcendence Scale

0-60 (higher score more death transcendence) (NCT00957359)
Timeframe: 2-4 weeks prior to drug administration/ Baseline

Interventionscore on a scale (Mean)
Psilocybin First, Then Niacin13.64
Niacin First, Then Psilocybin11.27

[back to top]

Demoralization Scale

0-96 (higher score more demoralized) (NCT00957359)
Timeframe: 2 weeks post drug administration 1

Interventionscore on a scale (Mean)
Psilocybin First, Then Niacin18.79
Niacin First, Then Psilocybin32.79

[back to top]

Demoralization Scale

0-96 (higher score more demoralized) (NCT00957359)
Timeframe: 2-4 weeks prior to drug administration/ Baseline

Interventionscore on a scale (Mean)
Psilocybin First, Then Niacin35.71
Niacin First, Then Psilocybin38.07

[back to top]

Demoralization Scale

0-96 (higher score more demoralized) (NCT00957359)
Timeframe: 26 weeks post drug administration 2

Interventionscore on a scale (Mean)
Psilocybin First, Then Niacin19.38
Niacin First, Then Psilocybin24.58

[back to top]

HADS Anxiety

0-21 (higher score more anxiety) (NCT00957359)
Timeframe: 1 day post drug administration 2

Interventionscore on a scale (Mean)
Psilocybin First, Then Niacin6.84
Niacin First, Then Psilocybin13.02

[back to top]

HADS Anxiety

Hospital Anxiety and Depression Scale (HADS) used for measuring anxiety; Scored on a scale of 0-21 (higher score more anxiety) (NCT00957359)
Timeframe: 1 day post drug administration 1

Interventionscore on a scale (Mean)
Psilocybin First, Then Niacin3.43
Niacin First, Then Psilocybin6.0

[back to top]

HADS Anxiety

Hospital Anxiety and Depression Scale (HADS) used for measuring anxiety; Scored on a scale of 0-21 (higher score more anxiety) (NCT00957359)
Timeframe: 1 day prior to drug administration 1

Interventionscore on a scale (Mean)
Psilocybin First, Then Niacin9.0
Niacin First, Then Psilocybin9.0

[back to top]

HADS Anxiety

Hospital Anxiety and Depression Scale (HADS) used for measuring anxiety; Scored on a scale of 0-21 (higher score more anxiety) (NCT00957359)
Timeframe: 1 day prior to drug administration 2

Interventionscore on a scale (Mean)
Psilocybin First, Then Niacin4.57
Niacin First, Then Psilocybin7.98

[back to top]

HADS Anxiety

Hospital Anxiety and Depression Scale (HADS) used for measuring anxiety; Scored on a scale of 0-21 (higher score more anxiety) (NCT00957359)
Timeframe: 2-4 weeks prior to drug administration

Interventionscore on a scale (Mean)
Psilocybin First, Then Niacin15.14
Niacin First, Then Psilocybin16.93

[back to top]

HADS Depression

0-21 (higher score more depression) (NCT00957359)
Timeframe: 1 day prior to drug administration 1

Interventionscore on a scale (Mean)
Psilocybin First, Then Niacin10.43
Niacin First, Then Psilocybin16.47

[back to top]

HADS Anxiety

Hospital Anxiety and Depression Scale (HADS) used for measuring anxiety; Scored on a scale of 0-21 (higher score more anxiety) (NCT00957359)
Timeframe: 26 weeks post drug administration 2

Interventionscore on a scale (Mean)
Psilocybin First, Then Niacin2.69
Niacin First, Then Psilocybin4.70

[back to top]

HADS Anxiety

Hospital Anxiety and Depression Scale (HADS) used for measuring anxiety; Scored on a scale of 0-21 (higher score more anxiety) (NCT00957359)
Timeframe: 6 weeks post drug administration 1

Interventionscore on a scale (Mean)
Psilocybin First, Then Niacin4.64
Niacin First, Then Psilocybin8.44

[back to top]

HADS Anxiety

Hospital Anxiety and Depression Scale (HADS) used for measuring anxiety; Scored on a scale of 0-21 (higher score more anxiety) (NCT00957359)
Timeframe: 6 weeks post drug administration 2

Interventionscore on a scale (Mean)
Psilocybin First, Then Niacin3.60
Niacin First, Then Psilocybin5.54

[back to top]

HADS Depression

0-21 (higher score more depression) (NCT00957359)
Timeframe: 2-4 weeks prior to drug administration/ Baseline

Interventionscore on a scale (Mean)
Psilocybin First, Then Niacin5.29
Niacin First, Then Psilocybin7

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HADS Depression

Hospital Anxiety and Depression Scale (HADS) used for measuring depression; Scored on a scale of 0-21 (higher score more depression) (NCT00957359)
Timeframe: 1 day post drug administration 1

Interventionscore on a scale (Mean)
Psilocybin First, Then Niacin4.21
Niacin First, Then Psilocybin12.07

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HADS Depression

Hospital Anxiety and Depression Scale (HADS) used for measuring depression; Scored on a scale of 0-21 (higher score more depression) (NCT00957359)
Timeframe: 1 day post drug administration 2

Interventionscore on a scale (Mean)
Psilocybin First, Then Niacin5.25
Niacin First, Then Psilocybin10.05

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HADS Depression

Hospital Anxiety and Depression Scale (HADS) used for measuring depression; Scored on a scale of 0-21 (higher score more depression) (NCT00957359)
Timeframe: 26 weeks post drug administration 2

Interventionscore on a scale (Mean)
Psilocybin First, Then Niacin6.48
Niacin First, Then Psilocybin9.06

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HADS Depression

Hospital Anxiety and Depression Scale (HADS) used for measuring depression; Scored on a scale of 0-21 (higher score more depression) (NCT00957359)
Timeframe: 6 weeks post drug administration 1

Interventionscore on a scale (Mean)
Psilocybin First, Then Niacin6.5
Niacin First, Then Psilocybin14.24

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HADS Depression

Hospital Anxiety and Depression Scale (HADS) used for measuring depression; Scored on a scale of 0-21 (higher score more depression) (NCT00957359)
Timeframe: 6 weeks post drug administration 2

Interventionscore on a scale (Mean)
Psilocybin First, Then Niacin6.31
Niacin First, Then Psilocybin9.65

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Hopelessness

0-16 (higher score more hopeless) (NCT00957359)
Timeframe: 2 weeks post drug administration 1

Interventionscore on a scale (Mean)
Psilocybin First, Then Niacin2.79
Niacin First, Then Psilocybin6.08

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Hopelessness

0-16 (higher score more hopeless) (NCT00957359)
Timeframe: 26 weeks post drug administration 2

Interventionscore on a scale (Mean)
Psilocybin First, Then Niacin2.30
Niacin First, Then Psilocybin3.86

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Hopelessness

0-16 (higher score more hopeless) (NCT00957359)
Timeframe: Baseline

Interventionscore on a scale (Mean)
Psilocybin First, Then Niacin5.71
Niacin First, Then Psilocybin6.73

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QoL Environment Scale

4-20 (higher score improved quality of life domain) (NCT00957359)
Timeframe: 2 weeks post drug administration 1

Interventionscore on a scale (Mean)
Psilocybin First, Then Niacin16.42
Niacin First, Then Psilocybin13.90

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QoL Environment Scale

4-20 (higher score improved quality of life domain) (NCT00957359)
Timeframe: 2-4 weeks prior to drug administration/ Baseline

Interventionscore on a scale (Mean)
Psilocybin First, Then Niacin15.75
Niacin First, Then Psilocybin14.93

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QoL Environment Scale

4-20 (higher score improved quality of life domain) (NCT00957359)
Timeframe: 26 weeks post drug administration 2

Interventionscore on a scale (Mean)
Psilocybin First, Then Niacin16.96
Niacin First, Then Psilocybin15.82

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QoL Physical Health Scale

4-20 (higher score improved quality of life domain) (NCT00957359)
Timeframe: 2 weeks post drug administration 1

Interventionscore on a scale (Mean)
Psilocybin First, Then Niacin16.0
Niacin First, Then Psilocybin12.44

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QoL Physical Health Scale

4-20 (higher score improved quality of life domain) (NCT00957359)
Timeframe: 2-4 weeks prior to drug administration/ Baseline

Interventionscore on a scale (Mean)
Psilocybin First, Then Niacin15.14
Niacin First, Then Psilocybin12.53

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QoL Physical Health Scale

4-20 (higher score improved quality of life domain) (NCT00957359)
Timeframe: 26 weeks post drug administration 2

Interventionscore on a scale (Mean)
Psilocybin First, Then Niacin16.77
Niacin First, Then Psilocybin14.14

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QoL Psychological Scale

4-20 (higher score improved quality of life domain) (NCT00957359)
Timeframe: 2 weeks post drug administration 1

Interventionscore on a scale (Mean)
Psilocybin First, Then Niacin15.43
Niacin First, Then Psilocybin12.28

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QoL Psychological Scale

4-20 (higher score improved quality of life domain) (NCT00957359)
Timeframe: 2-4 weeks prior to drug administration/ Baseline

Interventionscore on a scale (Mean)
Psilocybin First, Then Niacin13.57
Niacin First, Then Psilocybin12.67

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QoL Psychological Scale

4-20 (higher score improved quality of life domain) (NCT00957359)
Timeframe: 26 weeks post drug administration 2

Interventionscore on a scale (Mean)
Psilocybin First, Then Niacin15.78
Niacin First, Then Psilocybin14.90

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QoL Social Relationships Scale

4-20 (higher score improved quality of life domain) (NCT00957359)
Timeframe: 2 weeks post drug administration 1

Interventionscore on a scale (Mean)
Psilocybin First, Then Niacin14.86
Niacin First, Then Psilocybin12.78

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QoL Social Relationships Scale

4-20 (higher score improved quality of life domain) (NCT00957359)
Timeframe: 2-4 weeks prior to drug administration/ Baseline

Interventionscore on a scale (Mean)
Psilocybin First, Then Niacin13.62
Niacin First, Then Psilocybin13.24

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QoL Social Relationships Scale

4-20 (higher score improved quality of life domain) (NCT00957359)
Timeframe: 26 weeks post drug administration 2

Interventionscore on a scale (Mean)
Psilocybin First, Then Niacin15.6
Niacin First, Then Psilocybin13.71

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STAI State

"STAI scores 20-80 (higher score more anxiety). Commonly classified as no or low anxiety (20-37), moderate anxiety (38-44), and high anxiety (45-80)." (NCT00957359)
Timeframe: 1 day post drug administration 1

Interventionscore on a scale (Mean)
Psilocybin First, Then Niacin27.5
Niacin First, Then Psilocybin40.33

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STAI State

"STAI scores 20-80 (higher score more anxiety). Commonly classified as no or low anxiety (20-37), moderate anxiety (38-44), and high anxiety (45-80)." (NCT00957359)
Timeframe: 1 day post drug administration 2

Interventionscore on a scale (Mean)
Psilocybin First, Then Niacin25.73
Niacin First, Then Psilocybin38.11

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STAI State

"STAI scores 20-80 (higher score more anxiety). Commonly classified as no or low anxiety (20-37), moderate anxiety (38-44), and high anxiety (45-80)." (NCT00957359)
Timeframe: 1 day prior to drug administration 1

Interventionscore on a scale (Mean)
Psilocybin First, Then Niacin39.07
Niacin First, Then Psilocybin45.6

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STAI State

"STAI scores 20-80 (higher score more anxiety). Commonly classified as no or low anxiety (20-37), moderate anxiety (38-44), and high anxiety (45-80)." (NCT00957359)
Timeframe: 1 day prior to drug administration 2

Interventionscore on a scale (Mean)
Psilocybin First, Then Niacin32.72
Niacin First, Then Psilocybin45.31

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Death Anxiety Scale

0-15 (higher score more death anxiety) (NCT00957359)
Timeframe: 26 weeks post drug administration 2

Interventionscore on a scale (Mean)
Psilocybin First, Then Niacin6.71
Niacin First, Then Psilocybin6.83

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STAI State

"STAI scores 20-80 (higher score more anxiety). Commonly classified as no or low anxiety (20-37), moderate anxiety (38-44), and high anxiety (45-80)." (NCT00957359)
Timeframe: 26 weeks post drug administration 2

Interventionscore on a scale (Mean)
Psilocybin First, Then Niacin28.04
Niacin First, Then Psilocybin38.28

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STAI State

"STAI scores 20-80 (higher score more anxiety). Commonly classified as no or low anxiety (20-37), moderate anxiety (38-44), and high anxiety (45-80)." (NCT00957359)
Timeframe: 6 weeks post drug administration 1

Interventionscore on a scale (Mean)
Psilocybin First, Then Niacin33.5
Niacin First, Then Psilocybin47.05

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STAI State

"STAI scores 20-80 (higher score more anxiety). Commonly classified as no or low anxiety (20-37), moderate anxiety (38-44), and high anxiety (45-80)." (NCT00957359)
Timeframe: 6 weeks post drug administration 2

Interventionscore on a scale (Mean)
Psilocybin First, Then Niacin30.67
Niacin First, Then Psilocybin37.77

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STAI Trait

"STAI scores 20-80 (higher score more anxiety). Commonly classified as no or low anxiety (20-37), moderate anxiety (38-44), and high anxiety (45-80)." (NCT00957359)
Timeframe: 1 day post drug administration 2

Interventionscore on a scale (Mean)
Psilocybin First, Then Niacin25.73
Niacin First, Then Psilocybin38.11

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STAI Trait

"STAI scores 20-80 (higher score more anxiety). Commonly classified as no or low anxiety (20-37), moderate anxiety (38-44), and high anxiety (45-80)." (NCT00957359)
Timeframe: 1 day prior to drug administration 1

Interventionscore on a scale (Mean)
Psilocybin First, Then Niacin39.07
Niacin First, Then Psilocybin45.87

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STAI Trait

"STAI scores 20-80 (higher score more anxiety). Commonly classified as no or low anxiety (20-37), moderate anxiety (38-44), and high anxiety (45-80)." (NCT00957359)
Timeframe: 1 day prior to drug administration 2

Interventionscore on a scale (Mean)
Psilocybin First, Then Niacin32.72
Niacin First, Then Psilocybin45.31

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STAI Trait

"STAI scores 20-80 (higher score more anxiety). Commonly classified as no or low anxiety (20-37), moderate anxiety (38-44), and high anxiety (45-80)." (NCT00957359)
Timeframe: 2-4 weeks prior to drug administration/ Baseline

Interventionscore on a scale (Mean)
Psilocybin First, Then Niacin43.79
Niacin First, Then Psilocybin48.53

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STAI Trait

"STAI scores 20-80 (higher score more anxiety). Commonly classified as no or low anxiety (20-37), moderate anxiety (38-44), and high anxiety (45-80)." (NCT00957359)
Timeframe: 6 weeks post drug administration 1

Interventionscore on a scale (Mean)
Psilocybin First, Then Niacin33.5
Niacin First, Then Psilocybin46.19

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STAI Trait

"STAI scores 20-80 (higher score more anxiety). Commonly classified as no or low anxiety (20-37), moderate anxiety (38-44), and high anxiety (45-80)." (NCT00957359)
Timeframe: 6 weeks post drug administration 2

Interventionscore on a scale (Mean)
Psilocybin First, Then Niacin28.04
Niacin First, Then Psilocybin38.28

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STAI Trait

"STAI scores 20-80 (higher score more anxiety). Commonly classified as no or low anxiety (20-37), moderate anxiety (38-44), and high anxiety (45-80)." (NCT00957359)
Timeframe: 6 weeks prior to drug administration 2

Interventionscore on a scale (Mean)
Psilocybin First, Then Niacin30.67
Niacin First, Then Psilocybin37.77

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State-Trait Anxiety Inventory (STAI) State

"STAI scores 20-80 (higher score more anxiety). Commonly classified as no or low anxiety (20-37), moderate anxiety (38-44), and high anxiety (45-80)." (NCT00957359)
Timeframe: 2-4 weeks prior to drug administration/ Baseline

Interventionscore on a scale (Mean)
Psilocybin First, Then Niacin43.79
Niacin First, Then Psilocybin48.53

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Change in Percent Heavy Drinking Days

(NCT01534494)
Timeframe: weeks 5-12 post initiation of treatment vs. 12 weeks prior to treatment

Interventionpercentage of days (Mean)
Psilocybin-25.962

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Percent of Drinking Days

The Timeline Follow-back (TLFB) method is used to calculate the percentage of days that participants drank alcohol. The TLFB is a method for assessing the number of drinks of alcohol on a daily basis over the previous 30 days. For each day in the recall period, the participant indicates the number of drinks of alcohol they consumed. The TLFB provides a calendar prompt and number of other memory aids (e.g., holidays, payday, and other personally relevant dates) to facilitate accurate recall of drug use during the target period. (NCT02061293)
Timeframe: Baseline (Week 4)

Interventionpercentage of days (Mean)
Psilocybin52.98
Diphenhydramine45.99

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Short Inventory of Problems (SIP-2R) Score

15-item self-report questionnaire assessing problems related to alcohol use. Items are ranked on a 4-point Likert scale ranging from 0 (never) to 3 (daily or almost daily). The total score range is 0-45; the higher the score, the more problems related to alcohol use. (NCT02061293)
Timeframe: Baseline (Week 4)

Interventionscore on a scale (Mean)
Psilocybin20.26
Diphenhydramine21.6

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Short Inventory of Problems (SIP-2R) Score

15-item self-report questionnaire assessing problems related to alcohol use. Items are ranked on a 4-point Likert scale ranging from 0 (never) to 3 (daily or almost daily). The total score range is 0-45; the higher the score, the more problems related to alcohol use. (NCT02061293)
Timeframe: Week 36

Interventionscore on a scale (Mean)
Psilocybin6.59
Diphenhydramine13

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Drinks Per Day

The Timeline Follow-back (TLFB) method is used to calculate drinks per day. The TLFB is a method for assessing the number of drinks of alcohol on a daily basis over the previous 30 days. For each day in the recall period, the participant indicates the number of drinks of alcohol they consumed. The TLFB provides a calendar prompt and number of other memory aids (e.g., holidays, payday, and other personally relevant dates) to facilitate accurate recall of drug use during the target period. (NCT02061293)
Timeframe: Baseline (Week 4)

Interventiondrinks per day (Mean)
Psilocybin2.77
Diphenhydramine2.19

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Drinks Per Day

The Timeline Follow-back (TLFB) method is used to calculate drinks per day. The TLFB is a method for assessing the number of drinks of alcohol on a daily basis over the previous 30 days. For each day in the recall period, the participant indicates the number of drinks of alcohol they consumed. The TLFB provides a calendar prompt and number of other memory aids (e.g., holidays, payday, and other personally relevant dates) to facilitate accurate recall of drug use during the target period. (NCT02061293)
Timeframe: Follow Up (Weeks 5-36)

Interventiondrinks per day (Mean)
Psilocybin1.17
Diphenhydramine2.26

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Drinks Per Day

The Timeline Follow-back (TLFB) method is used to calculate drinks per day. The TLFB is a method for assessing the number of drinks of alcohol on a daily basis over the previous 30 days. For each day in the recall period, the participant indicates the number of drinks of alcohol they consumed. The TLFB provides a calendar prompt and number of other memory aids (e.g., holidays, payday, and other personally relevant dates) to facilitate accurate recall of drug use during the target period. (NCT02061293)
Timeframe: Screening (Week 0)

Interventiondrinks per day (Mean)
Psilocybin5.2
Diphenhydramine4.38

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Percent of Participants Achieving WHO Risk Drinking Level Decrease of at Least 1 Level

For men, WHO low risk drinking (level 1) is defined as >0 grams of alcohol/day (g/d) to 40 g/d; moderate risk (level 2) as >40 g/d to 60 g/d; high risk (level 3) as >60 g/d to 100 g/d; and very high risk (level 4) as >100 g/d. For women, low risk (level 1) is defined as >0 g/d to 20 g/d; moderate risk (level 2) as >20 g/d to 40 g/d; high risk (level 3) as >40 g/d to 60 g/d; and very high risk (level 4) as >60 g/d. Abstinence was defined as no risk (level 0). (NCT02061293)
Timeframe: From Week 33 Up to Week 36

InterventionPercentage of participants (Number)
Psilocybin89.6
Diphenhydramine64.4

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Percent of Drinking Days

The Timeline Follow-back (TLFB) method is used to calculate the percentage of days that participants drank alcohol. The TLFB is a method for assessing the number of drinks of alcohol on a daily basis over the previous 30 days. For each day in the recall period, the participant indicates the number of drinks of alcohol they consumed. The TLFB provides a calendar prompt and number of other memory aids (e.g., holidays, payday, and other personally relevant dates) to facilitate accurate recall of drug use during the target period. (NCT02061293)
Timeframe: Follow Up (Weeks 5-36)

Interventionpercentage of days (Mean)
Psilocybin29.39
Diphenhydramine42.83

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Percent of Drinking Days

The Timeline Follow-back (TLFB) method is used to calculate the percentage of days that participants drank alcohol. The TLFB is a method for assessing the number of drinks of alcohol on a daily basis over the previous 30 days. For each day in the recall period, the participant indicates the number of drinks of alcohol they consumed. The TLFB provides a calendar prompt and number of other memory aids (e.g., holidays, payday, and other personally relevant dates) to facilitate accurate recall of drug use during the target period. (NCT02061293)
Timeframe: Screening (Week 0)

Interventionpercentage of days (Mean)
Psilocybin78.03
Diphenhydramine71.68

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Percent of Heavy Drinking Days

The Timeline Follow-back (TLFB) method is used to calculate the percent of heavy drinking days. The TLFB is a method for assessing the number of drinks of alcohol on a daily basis over the previous 30 days. For each day in the recall period, the participant indicates the number of drinks of alcohol they consumed. The TLFB provides a calendar prompt and number of other memory aids (e.g., holidays, payday, and other personally relevant dates) to facilitate accurate recall of drug use during the target period. Heavy drinking is defined as ≥4 drinks per day for women and ≥5 drinks per day for men. (NCT02061293)
Timeframe: Baseline (Week 4)

Interventionpercentage of days (Mean)
Psilocybin24.11
Diphenhydramine21.31

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Percent of Heavy Drinking Days

The Timeline Follow-back (TLFB) method is used to calculate the percent of heavy drinking days. The TLFB is a method for assessing the number of drinks of alcohol on a daily basis over the previous 30 days. For each day in the recall period, the participant indicates the number of drinks of alcohol they consumed. The TLFB provides a calendar prompt and number of other memory aids (e.g., holidays, payday, and other personally relevant dates) to facilitate accurate recall of drug use during the target period. Heavy drinking is defined as ≥4 drinks per day for women and ≥5 drinks per day for men. (NCT02061293)
Timeframe: Follow Up (Weeks 5-36)

Interventionpercentage of days (Mean)
Psilocybin9.71
Diphenhydramine23.57

[back to top]

Percent of Heavy Drinking Days

The Timeline Follow-back (TLFB) method is used to calculate the percent of heavy drinking days. The TLFB is a method for assessing the number of drinks of alcohol on a daily basis over the previous 30 days. For each day in the recall period, the participant indicates the number of drinks of alcohol they consumed. The TLFB provides a calendar prompt and number of other memory aids (e.g., holidays, payday, and other personally relevant dates) to facilitate accurate recall of drug use during the target period. Heavy drinking is defined as ≥4 drinks per day for women and ≥5 drinks per day for men. (NCT02061293)
Timeframe: Screening (Week 0)

Interventionpercentage of days (Mean)
Psilocybin56.48
Diphenhydramine48.57

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Percent of Participants Achieving No Heavy Drinking Days

The Timeline Follow-back (TLFB) method is used in calculating the number of heavy drinking days. The TLFB is a method for assessing the number of drinks of alcohol on a daily basis over the previous 30 days. For each day in the recall period, the participant indicates the number of drinks of alcohol they consumed. The TLFB provides a calendar prompt and number of other memory aids (e.g., holidays, payday, and other personally relevant dates) to facilitate accurate recall of drug use during the target period. Heavy drinking is defined as ≥4 drinks per day for women and ≥5 drinks per day for men. (NCT02061293)
Timeframe: From Week 5 (1 week after first drug administration) up to Week 36

InterventionPercentage of participants (Number)
Psilocybin33.3
Diphenhydramine11.1

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Percent of Participants Achieving No Heavy Drinking Days

The Timeline Follow-back (TLFB) method is used in calculating the number of heavy drinking days. The TLFB is a method for assessing the number of drinks of alcohol on a daily basis over the previous 30 days. For each day in the recall period, the participant indicates the number of drinks of alcohol they consumed. The TLFB provides a calendar prompt and number of other memory aids (e.g., holidays, payday, and other personally relevant dates) to facilitate accurate recall of drug use during the target period. Heavy drinking is defined as ≥4 drinks per day for women and ≥5 drinks per day for men. (NCT02061293)
Timeframe: From Week 33 Up to Week 36

InterventionPercentage of participants (Number)
Psilocybin62.5
Diphenhydramine40

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Percent of Participants Achieving WHO Risk Drinking Level Decrease of at Least 1 Level

For men, WHO low risk drinking (level 1) is defined as >0 grams of alcohol/day (g/d) to 40 g/d; moderate risk (level 2) as >40 g/d to 60 g/d; high risk (level 3) as >60 g/d to 100 g/d; and very high risk (level 4) as >100 g/d. For women, low risk (level 1) is defined as >0 g/d to 20 g/d; moderate risk (level 2) as >20 g/d to 40 g/d; high risk (level 3) as >40 g/d to 60 g/d; and very high risk (level 4) as >60 g/d. Abstinence was defined as no risk (level 0). (NCT02061293)
Timeframe: From Week 5 (1 week after first drug administration) up to Week 36

InterventionPercentage of participants (Number)
Psilocybin83.3
Diphenhydramine71.1

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Percent of Participants Achieving WHO Risk Drinking Level Decrease of at Least 2 Levels

For men, WHO low risk drinking (level 1) is defined as >0 grams of alcohol/day (g/d) to 40 g/d; moderate risk (level 2) as >40 g/d to 60 g/d; high risk (level 3) as >60 g/d to 100 g/d; and very high risk (level 4) as >100 g/d. For women, low risk (level 1) is defined as >0 g/d to 20 g/d; moderate risk (level 2) as >20 g/d to 40 g/d; high risk (level 3) as >40 g/d to 60 g/d; and very high risk (level 4) as >60 g/d. Abstinence was defined as no risk (level 0). (NCT02061293)
Timeframe: From Week 33 Up to Week 36

InterventionPercentage of participants (Number)
Psilocybin60.4
Diphenhydramine40

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Percent of Participants Achieving WHO Risk Drinking Level Decrease of at Least 2 Levels

For men, WHO low risk drinking (level 1) is defined as >0 grams of alcohol/day (g/d) to 40 g/d; moderate risk (level 2) as >40 g/d to 60 g/d; high risk (level 3) as >60 g/d to 100 g/d; and very high risk (level 4) as >100 g/d. For women, low risk (level 1) is defined as >0 g/d to 20 g/d; moderate risk (level 2) as >20 g/d to 40 g/d; high risk (level 3) as >40 g/d to 60 g/d; and very high risk (level 4) as >60 g/d. Abstinence was defined as no risk (level 0). (NCT02061293)
Timeframe: From Week 5 (1 week after first drug administration) up to Week 36

InterventionPercentage of participants (Number)
Psilocybin60.4
Diphenhydramine40

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Percent of Participants Achieving WHO Risk Drinking Level Decrease of at Least 3 Levels

For men, WHO low risk drinking (level 1) is defined as >0 grams of alcohol/day (g/d) to 40 g/d; moderate risk (level 2) as >40 g/d to 60 g/d; high risk (level 3) as >60 g/d to 100 g/d; and very high risk (level 4) as >100 g/d. For women, low risk (level 1) is defined as >0 g/d to 20 g/d; moderate risk (level 2) as >20 g/d to 40 g/d; high risk (level 3) as >40 g/d to 60 g/d; and very high risk (level 4) as >60 g/d. Abstinence was defined as no risk (level 0). (NCT02061293)
Timeframe: From Week 33 up to Week 36

InterventionPercentage of participants (Number)
Psilocybin37.5
Diphenhydramine17.8

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Percent of Participants Achieving WHO Risk Drinking Level Decrease of at Least 3 Levels

For men, WHO low risk drinking (level 1) is defined as >0 grams of alcohol/day (g/d) to 40 g/d; moderate risk (level 2) as >40 g/d to 60 g/d; high risk (level 3) as >60 g/d to 100 g/d; and very high risk (level 4) as >100 g/d. For women, low risk (level 1) is defined as >0 g/d to 20 g/d; moderate risk (level 2) as >20 g/d to 40 g/d; high risk (level 3) as >40 g/d to 60 g/d; and very high risk (level 4) as >60 g/d. Abstinence was defined as no risk (level 0). (NCT02061293)
Timeframe: From Week 5 (1 week after first drug administration) up to Week 36

InterventionPercentage of participants (Number)
Psilocybin29.92
Diphenhydramine13.3

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Percentage of Participants Achieving Abstinence From Drinking

The Timeline Follow-back (TLFB) method is used in calculating abstinence from drinking. The TLFB is a method for assessing the number of drinks of alcohol on a daily basis over the previous 30 days. For each day in the recall period, the participant indicates the number of drinks of alcohol they consumed. The TLFB provides a calendar prompt and number of other memory aids (e.g., holidays, payday, and other personally relevant dates) to facilitate accurate recall of drug use during the target period. Abstinence is defined as zero drinks of alcohol over the target period. (NCT02061293)
Timeframe: From Week 33 up to Week 36

InterventionPercentage of participants (Number)
Psilocybin47.9
Diphenhydramine24.4

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Percentage of Participants Achieving Abstinence From Drinking

The Timeline Follow-back (TLFB) method is used in calculating abstinence from drinking. The TLFB is a method for assessing the number of drinks of alcohol on a daily basis over the previous 30 days. For each day in the recall period, the participant indicates the number of drinks of alcohol they consumed. The TLFB provides a calendar prompt and number of other memory aids (e.g., holidays, payday, and other personally relevant dates) to facilitate accurate recall of drug use during the target period. Abstinence is defined as zero drinks of alcohol over the target period. (NCT02061293)
Timeframe: From Week 5 (1 week after first drug administration) up to Week 36

InterventionPercentage of participants (Number)
Psilocybin22.9
Diphenhydramine8.9

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Change From Baseline in State-Trait Anxiety Inventory (Trait) at End-of-treatment

Trait anxiety self-report measure. Minimum = 0. Maximum = 80. Higher scores mean a worse outcome. (NCT02950467)
Timeframe: Baseline and end-of-treatment (7 weeks duration)

Interventionunits on a scale (Mean)
Group Therapy Plus Psilocybin-6.06

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Change in Average Score on Subscales of Group Questionnaire Pre-drug vs Post-drug

The Group Questionnaire is a self-report measure with three sub-scales that measure Positive Bonding, Positive Working and Negative Relationship dimensions of the relationships at 3 levels: between group members, between group members and group therapists, and between group members and the group as a whole. Each subscale score is calculated by summation of the ratings across all three levels for each subscale. Positive Bonding scores range from 13 to 91 with higher scores indicating a better outcome. Positive Working scores range 8 to 56 with higher scores indicating a better outcome. Negative Relationship scores range 9 to 63 with higher scores indicating worse outcomes. (NCT02950467)
Timeframe: Mean scores averaged over 2 weeks pre-medication compared to 3 weeks post-medication.

Interventionscore on a scale (Mean)
Positive Bonding (Overall)Positive Working (Overall)Negative Relationship (Overall)
Group Therapy Plus Psilocybin2.611.87-0.69

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Subject Recruitment and Retention

Two therapy groups of at least 4 subjects each will complete the study (NCT02950467)
Timeframe: Duration of study, about 24 months

InterventionParticipants (Count of Participants)
EnrolledCompleted Safety Assessment at End-of-treatmentCompleted Safety Assessment at 3-month follow-up
Group Therapy Plus Psilocybin181818

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Change From Baseline in McGill Quality of Life Questionnaire-Revised (Overall) at 3-month Follow-up

Self-report quality of life measure. Only item A) Overall quality of life. Minimum = 0 (Very bad). Maximum = 10 (Excellent). Higher scores mean better outcomes. (NCT02950467)
Timeframe: Baseline and 3-month follow-up

Interventionunits on a scale (Mean)
Group Therapy Plus Psilocybin0.94

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Change From Baseline in Antiretroviral Medication Adherence Scale at 3-month Follow-up

Self-report last-month antiviral medication adherence. Minimum = 0%. Maximum = 100%. Higher scores mean a better outcome. (NCT02950467)
Timeframe: Baseline and 3-month follow-up

Interventionunits on a scale (Mean)
Group Therapy Plus Psilocybin-0.94

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Change From Baseline in Antiretroviral Medication Adherence Scale at End-of-treatment

Self-report last-month antiviral medication adherence. Minimum = 0%. Maximum = 100%. Higher scores mean a better outcome. (NCT02950467)
Timeframe: Baseline and end-of-treatment (7 weeks duration)

Interventionunits on a scale (Mean)
Group Therapy Plus Psilocybin-0.71

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Change From Baseline in Center for Epidemiologic Studies Depression Scale-Revised at 3-month Follow-up

Depression self-report measure. Minimum = 0. Maximum = 60. Higher scores mean a worse outcome. (NCT02950467)
Timeframe: Baseline and 3-month follow-up

Interventionunits on a scale (Mean)
Group Therapy Plus Psilocybin-8.89

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Change From Baseline in Center for Epidemiologic Studies Depression Scale-Revised at End-of-treatment

Depression self-report measure. Minimum = 0. Maximum = 60. Higher scores mean a worse outcome. (NCT02950467)
Timeframe: Baseline and end-of-treatment (7 weeks duration)

Interventionunits on a scale (Mean)
Group Therapy Plus Psilocybin-8.94

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Change From Baseline in Demoralization Scale-II at 3-month Follow-up

Demoralization self-report measure. Minimum = 0. Maximum = 32. Higher scores mean a worse outcome. (NCT02950467)
Timeframe: Baseline and 3-month follow-up

Interventionunits on a scale (Mean)
Group Therapy Plus Psilocybin-5.78

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Change From Baseline in Demoralization Scale-II at End-of-treatment

Demoralization self-report measure. Minimum = 0. Maximum = 32. Higher scores means a worse outcome. (NCT02950467)
Timeframe: Baseline and end-of-treatment (7 weeks duration)

Interventionunits on a scale (Mean)
Group Therapy Plus Psilocybin-6.67

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Change From Baseline in Experiences in Closer Relationships-M16 (Anxiety) at 3-month Follow-up

Self-report measure of attachment anxiety. Minimum = 8. Maximum = 56. Higher scores mean worse outcomes. (NCT02950467)
Timeframe: Baseline and 3-month follow-up

Interventionunits on a scale (Mean)
Group Therapy Plus Psilocybin-3.33

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Change From Baseline in Experiences in Closer Relationships-M16 (Anxiety) at End-of-treatment

Self-report measure of attachment anxiety. Minimum = 8. Maximum = 56. Higher scores mean worse outcomes. (NCT02950467)
Timeframe: Baseline and end-of-treatment (7 weeks duration)

Interventionunits on a scale (Mean)
Group Therapy Plus Psilocybin-0.78

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Change From Baseline in Experiences in Closer Relationships-M16 (Avoidance) at 3-month Follow-up

Self-report measure of attachment avoidance. Minimum = 8. Maximum = 56. Higher scores mean worse outcomes. (NCT02950467)
Timeframe: Baseline and 3-month follow-up

Interventionunits on a scale (Mean)
Group Therapy Plus Psilocybin-0.06

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Change From Baseline in Experiences in Closer Relationships-M16 (Avoidance) at End-of-treatment

Self-report measure of attachment avoidance. Minimum = 8. Maximum = 56. Higher scores mean worse outcomes. (NCT02950467)
Timeframe: Baseline and end-of-treatment (7 weeks duration)

Interventionunits on a scale (Mean)
Group Therapy Plus Psilocybin-2.72

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Change From Baseline in Inventory of Complicated Grief at 3-month Follow-up

Complicated Grief self-report measure. Minimum = 0, Maximum = 76. Higher scores mean worse outcome. (NCT02950467)
Timeframe: Baseline and 3-month follow-up

Interventionunits on a scale (Mean)
Group Therapy Plus Psilocybin-7.06

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Change From Baseline in Inventory of Complicated Grief-Revised at End-of-treatment

Complicated Grief self-report measure. Minimum = 0, Maximum = 76. Higher scores mean worse outcome. (NCT02950467)
Timeframe: Baseline and end-of-treatment (7 weeks duration)

Interventionunits on a scale (Mean)
Group Therapy Plus Psilocybin-6.22

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Change From Baseline in McGill Quality of Life Questionnaired-Revised (Overall) at End-of-treatment

Self-report quality of life measure. Only item A) Overall quality of life. Minimum = 0 (Very bad). Maximum = 10 (Excellent). Higher scores mean better outcomes. (NCT02950467)
Timeframe: Baseline and end-of-treatment (7 weeks duration)

Interventionunits on a scale (Mean)
Group Therapy Plus Psilocybin2.0

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Change From Baseline in PTSD Checklist 5 at 3-month Follow-up

PTSD self-report measure. Minimum = 0. Maximum = 80. Higher scores mean a worse outcome. (NCT02950467)
Timeframe: Baseline and 3-month follow-up

Interventionunits on a scale (Mean)
Group Therapy Plus Psilocybin-7.11

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Change From Baseline in PTSD Checklist 5 at End-of-treatment

PTSD self-report measure. Minimum = 0. Maximum = 80. Higher scores mean a worse outcome. (NCT02950467)
Timeframe: Baseline and end-of-treatment (7 weeks duration)

Interventionunits on a scale (Mean)
Group Therapy Plus Psilocybin-9

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Change From Baseline in State-Trait Anxiety Inventory (State) at 3-month Follow-up

State anxiety self-report measure. Minimum = 0. Maximum = 80. Higher scores mean a worse outcome. (NCT02950467)
Timeframe: Baseline and 3-month follow-up

Interventionunits on a scale (Mean)
Group Therapy Plus Psilocybin1.06

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Change From Baseline in State-Trait Anxiety Inventory (State) at End-of-treatment

State anxiety self-report measure. Minimum = 0. Maximum = 80. Higher scores mean a worse outcome. (NCT02950467)
Timeframe: Baseline and end-of-treatment (7 weeks duration)

Interventionunits on a scale (Mean)
Group Therapy Plus Psilocybin-5.56

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Change From Baseline in State-Trait Anxiety Inventory (Trait) at 3-month Follow-up

Trait anxiety self-report measure. Minimum = 0. Maximum = 80. Higher scores mean a worse outcome. (NCT02950467)
Timeframe: Baseline and 3-month follow-up

Interventionunits on a scale (Mean)
Group Therapy Plus Psilocybin-3.39

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Change in Emotional Functioning Tasks Response Time (Milliseconds)

"These tasks measure emotional responding that may be altered by psilocybin.~Emotional discrimination task: participants were presented with images of emotional facial expressions or shapes (control), and were instructed to discriminate between the images.~Emotion recognition task: participants were presented images of actors and were asked to identify the emotional facial expression (happy, sad, fear, angry, neutral) of each actor.~Emotional conflict Stroop task: participants were shown emotional facial expressions (targets) with emotional words overlain (distractors) and were asked to identify the valence of the facial expression, either positive or negative." (NCT02971605)
Timeframe: 1-day pre (baseline), 1-week post, 1-month post session

,,
Interventionmilliseconds (Mean)
Emotion recognition task: HappyEmotion recognition task: SadEmotion recognition task: FearfulEmotion recognition task: AngryEmotion recognition task: NeutralEmotion discrimination task: ShapesEmotion discrimination task: FacesEmotional conflict Stroop: CongruentEmotional conflict Stroop: Incongruent
1-month Post Session1454159611301310101717351522603.2614.1
1-week Post Session1383145810451193159416971572606.3631.4
Baseline16701539106113801305977.01803613.5641.3

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Change in Longitudinal Emotion and Mood Questionnaire Scores

"Participants were assessed on a variety of questionnaires that probed emotional functioning and mood state. Higher scores on each subscale are indicative of higher levels of each emotion/mood (e.g., low score on Depression (POMS) indicates low level of depressed mood).~Depression Anxiety Stress Scale (DASS): Range 0-56 on all subscales~Dispositional Positive Emotion Scale (DPES): Range 1-7 on all subscales~Positive & Negative Affect Schedule Expanded (PANAS-X): Range 0-50 on all subscales~Profile of Mood States (POMS): Ranges vary by subscale. Tension (0-36); Depression (0-60); Anger (0-48); Fatigue (0-28); Confusion (0-28); Vigor (0-36); Mood Disturbance (-36-168)~State Trait Anxiety Inventory (STAI): Range 20-80 on all subscales~Tellegen Absorption Scale (TAS): Range 0-34~Big Five Inventory (BFI): Range 1-5 on all subscales" (NCT02971605)
Timeframe: 1 day pre (baseline), 1 week post, and 1 month post session

Interventionscore on a scale (Mean)
Depression (DASS)Anxiety (DASS)Stress (DASS)Joy (DPES)Content (DPES)Pride (DPES)Love (DPES)Compassion (DPES)Amusement (DPES)Awe (DPES)Positive Affect (PANAS-X)Negative Affect (PANAS-X)Tension (POMS)Depression (POMS)Anger (POMS)Fatigue (POMS)Confusion (POMS)Vigor (POMS)Mood Disturbance (POMS)State Anxiety (STAI)Trait Anxiety (STAI)
1-week Post Session1.091.642.006.026.275.965.926.255.606.0640.6412.361.730.552.182.274.2721.45-10.522.8228.55

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Change in Longitudinal Emotion and Mood Questionnaire Scores

"Participants were assessed on a variety of questionnaires that probed emotional functioning and mood state. Higher scores on each subscale are indicative of higher levels of each emotion/mood (e.g., low score on Depression (POMS) indicates low level of depressed mood).~Depression Anxiety Stress Scale (DASS): Range 0-56 on all subscales~Dispositional Positive Emotion Scale (DPES): Range 1-7 on all subscales~Positive & Negative Affect Schedule Expanded (PANAS-X): Range 0-50 on all subscales~Profile of Mood States (POMS): Ranges vary by subscale. Tension (0-36); Depression (0-60); Anger (0-48); Fatigue (0-28); Confusion (0-28); Vigor (0-36); Mood Disturbance (-36-168)~State Trait Anxiety Inventory (STAI): Range 20-80 on all subscales~Tellegen Absorption Scale (TAS): Range 0-34~Big Five Inventory (BFI): Range 1-5 on all subscales" (NCT02971605)
Timeframe: 1 day pre (baseline), 1 week post, and 1 month post session

,
Interventionscore on a scale (Mean)
Depression (DASS)Anxiety (DASS)Stress (DASS)Joy (DPES)Content (DPES)Pride (DPES)Love (DPES)Compassion (DPES)Amusement (DPES)Awe (DPES)Positive Affect (PANAS-X)Negative Affect (PANAS-X)Tension (POMS)Depression (POMS)Anger (POMS)Fatigue (POMS)Confusion (POMS)Vigor (POMS)Mood Disturbance (POMS)State Anxiety (STAI)Trait Anxiety (STAI)Extraversion (BFI)Agreeableness (BFI)Conscientiousness (BFI)Neuroticism (BFI)Openness (BFI)Absorption (TAS)
1-month Post Session1.641.453.275.926.135.955.986.005.715.8840.1816.093.822.644.642.724.7222.09-3.5525.6425.643.694.333.981.674.221.31
Baseline1.821.644.915.455.625.425.615.755.025.5238.1816.094.823.364.914.095.5519.093.6428.031.363.464.433.821.824.170.98

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Change in Emotional Functioning Task Accuracy

"These tasks measure emotional responding that may be altered by psilocybin.~Emotional discrimination task: participants were presented with images of emotional facial expressions or shapes (control), and were instructed to discriminate between the images.~Emotion recognition task: participants were presented images of actors and were asked to identify the emotional facial expression (happy, sad, fear, angry, neutral) of each actor.~Emotional conflict Stroop task: participants were shown emotional facial expressions (targets) with emotional words overlain (distractors) and were asked to identify the valence of the facial expression, either positive or negative." (NCT02971605)
Timeframe: 1 day pre (baseline), 1 week post, and 1 month post session

,,
Interventionpercentage of correct responses (Mean)
Emotion recognition task: HappyEmotion recognition task: SadEmotion recognition task: FearfulEmotion recognition task: AngryEmotion recognition task: NeutralEmotion discrimination: Shapes (Control)Emotion discrimination: FacesEmotional conflict Stroop: CongruentEmotional conflict Stroop: Incongruent
1-month Post Session97.994.897.999.0100.095.093.299.598.4
1-week Post Session95.893.899.095.896.997.092.399.897.9
Baseline92.695.7100.097.993.897.087.199.598.1

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Amygdala Response to Stimuli in the Emotion Recognition Test

Blood oxygenation level-dependent (BOLD) percent signal change in response to stimuli in the emotion recognition task was measured in the left and right amygdala. (NCT02971605)
Timeframe: 1 day pre (baseline), 1 week post, and 1 month post session

,,
InterventionBOLD percent signal change (Mean)
L Amygdala contrast: HappyL Amygdala contrast: SadL Amygdala contrast: FearfulL Amygdala contrast: AngryL Amygdala contrast: NeutralR Amygdala contrast: HappyR Amygdala contrast: SadR Amygdala contrast: FearfulR Amygdala contrast: AngryR Amygdala contrast: Neutral
1-month Post Session0.6190.9990.6641.1311.0980.7490.8160.6170.6890.719
1-week Post Session-0.759-0.514-0.928-0.881-0.825-0.0520.004-0.254-0.028-0.256
Baseline0.8350.5030.5250.5140.7940.9380.9270.9790.8341.081

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The GRID-Hamilton Depression Rating Scale (GRID-HAMD)

"The GRID-Hamilton Depression Rating Scale is a 17-item clinician-administered rating scale designed to assess severity of depressive symptoms. The score range for the GRID-HAMD is 0 to 52, with higher score indicating more severe depression. For this clinician-rated measure, a clinically significant response was defined as ⩾50% decrease in measure relative to Baseline; symptom remission was defined as ⩾50% decrease in measure relative to Baseline and a score of ⩽7 on the GRID-HAMD~Week 0 Baseline = Initial baseline assessment~Week 5 Waitlist-Period (Delayed Group Only) = 5 weeks post enrollment, but pre-study drug in the Delayed Treatment group only.~Week 8 Waitlist-Period (Delayed Group Only) = 8 weeks post enrollment, but pre-study drug in the Delayed Treatment group only.~Week 1 Post Psilocybin Treatment = 1 week after the second psilocybin session in both the Immediate Treatment group (Week 5) and Delayed Treatment group (Week 13)" (NCT03181529)
Timeframe: Baseline (Week 0) to 1-week after second psilocybin session (Week 8 in Immediate Treatment; Week 13 in Delayed Treatment). The first psilocybin session (20 mg/70 kg) and second psilocybin session (30 mg/70 kg) are spaced approximately 1 week apart.

,
Interventionunits on a scale (Mean)
BaselineWeek 5 Waitlist-Period (Delayed Group Only)Week 8 Waitlist-Period (Delayed Group Only)Week 1 Post Psilocybin Treatment
Delayed Treatment22.523.823.59.5
Immediate Treatment22.9NANA8.0

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MADRS Change From Baseline to Week 3, Sensitivity Analysis

MADRS is a clinician-rated scale measuring depression symptom severity, consisting of 10 items, each scored from 0 (normal) to 6 (severe), for a total possible score of between 0 to 60; higher scores denote greater severity. Response >= 50% decrease and remission <= 10 total score. (NCT03775200)
Timeframe: Change from Baseline to Week 3

Interventionunits on a scale (Mean)
25 mg COMP360 Psilocybin-12
10 mg COMP360 Psilocybin-8.9
1 mg COMP360 Psilocybin-6.7

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Montgomery Asberg Depression Rating Scale (MADRS) Change From Baseline to Week 3

MADRS is a clinician-rated scale measuring depression symptom severity, consisting of 10 items, each scored from 0 (normal) to 6 (severe), for a total possible score of between 0 to 60; higher scores denote greater severity. Response >= 50% decrease and remission <= 10 total score. (NCT03775200)
Timeframe: Change from Baseline to Week 3

Interventionunits on a scale (Mean)
25 mg COMP360 Psilocybin-12
10 mg COMP360 Psilocybin-8.9
1 mg COMP360 Psilocybin-6.8

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Body Dysmorphic Disorder Modification of the Yale-Brown Obsessive Compulsive Disorder Scale

The Yale-Brown Obsessive Compulsive Scale Modified for Body Dysmorphic Disorder (BDD-YBOCS) is a 12-item, semi-structured, rater-administered measure that assesses body dysmorphic disorder severity during the past week. Scores for each item range from 0 (no symptoms) to 4 (extreme symptoms); the total score ranges from 0 to 48, with higher scores reflecting more severe symptoms. (NCT04656301)
Timeframe: From baseline (day -1) up to 3 months post-dose

Interventionscore on a scale (Mean)
Psilocybin18.42

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Improvement in Clinical Global Impression - Severity

"Changes from Baseline in Clinical Global Impression-Severity score at Week 3 post psilocybin administration.~The minimum and maximum values are 1 and 7 and a higher score means a worse outcome." (NCT04739865)
Timeframe: 3 weeks

Interventionunits on a scale (Mean)
25 mg COMP360 Psilocybin-1.3

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Improvement in Depressive Symptoms

"Change in Montgomery-Asberg Depression Rating Scale (MADRS) total score from Baseline to 3 weeks post psilocybin administration.~The minimum and maximum MADRS total score values are 0 and 60 and a higher score means a worse outcome." (NCT04739865)
Timeframe: 3 weeks

Interventionunits on a scale (Mean)
25 mg COMP360 Psilocybin-14.9

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Incidence of Remission

The proportion of participants with remission (defined as Montgomery-Asberg Depression Rating Scale [MADRS] total score ≤ 10) at Week 3 post psilocybin administration The minimum and maximum MADRS total score values are 0 and 60 and a higher score means a worse outcome. (NCT04739865)
Timeframe: 3 weeks

InterventionParticipants (Count of Participants)
25 mg COMP360 Psilocybin8

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Incidence of Response

"The proportion of participants with a response (defined as a ≥ 50% improvement in Montgomery-Asberg Depression Rating Scale [MADRS] total score from Baseline) at Week 3 post psilocybin administration.~The minimum and maximum MADRS total score values are 0 and 60 and a higher score means a worse outcome." (NCT04739865)
Timeframe: 3 weeks

InterventionParticipants (Count of Participants)
25 mg COMP360 Psilocybin8

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