Depression: Psilocybin-Assisted Therapy vs. Control

S. Parker Singleton

, Brooke L. Sevchik

, Analiese Lahey

, Megan Jones

, Sandeep N. Nayak

, Eric C. Strain

, Simon N. Vandekar

, Robert H. Dworkin

, J. Cobb Scott

, Theodore D. Satterthwaite

General Description

The data-depression-psiloctr dataset is a meta-analytic research domain (MARD) on psilocybin-assisted therapies for adults with depressive symptoms. This MARD is part of the Metapsy project. The date of the last search update is provided here. This dataset includes psilocybin-assisted therapy vs. control (‘psy vs ctr’) comparisons. Effect sizes are provided for outcomes at post-test and long-term follow-ups, if available.

This living database has been developed by the Sypres (Synthesis of Psychedelic Research Studies) Collaboration. Further information on Sypres and its underlying methodology can be found in this published article.

The dataset follows the Metapsy data standard. All included information has been independently extracted two researchers. Risk of bias ratings were conducted using the Cochrane Collaboration Risk of Bias Tool (version 2).

Affiliated Institutions

University of Pennsylvania, Johns Hopkins University, Vanderbilt University, University of Rochester

Online Meta-Analysis Tool

A simplified version of this database can be analyzed at metapsy.org/sypres/psilocybin-depression.

Metadata

metapsyData Shorthand: depression-psiloctr
Number of Studies: 12
Latest Version: 25.0.5
Last updated: August 5, 2025
Last search: July 1, 2025
Search String (Latest Version): ↗
Data Repository (Latest Version): ↗
Preregistration (Research Domain): ↗
License: ODC-By v1.0 ↗
Database DOI:

Version 25.0.5 (August 5, 2025):
Version 25.0.4 (July 4, 2025):
Version 25.0.3 (June 23, 2025):
Version 25.0.2 (June 22, 2025):
Version 25.0.1 (June 22, 2025):
Version 25.0.0 (June 22, 2025):

Variable Description

Variable	Description
`study`	Author of the study and year of publication
`condition_arm1`	condition in the first arm (psil = psilocybin)
`condition_arm2`	condition in the second arm (psil = psilocybin, wl = waitlist control, ncn = niacin,pcb = placebo,
`multi_arm1`	distinguishes arms in multi-arm studies (e.g. dose of psilocybin)
`multi_arm2`	distinguishes arms in multi-arm studies (e.g. dose of psilocybin)
`outcome_type`	how the outcome is reported (change = change from baseline score, msd = endpoint mean and standard deviation, response = response (dichotomous outcome), remission = remission (dichotomous outcome), imsd = imputed endpoint mean and standard deviation (calculated for studies initially reported only as change from baseline)
`instrument`	depression instrument used to measure outcome
`rating`	describes who administers or completes the depression instrument (clinician = clinician-rated scale, self-report = self-report scale)
`instrument_symptom`	describes the symptom the instrument surveys (depression)
`primary_instrument`	describes if the instrument listed was reported as or chosen as the primary outcome instrument (1 = yes, 0 = no)
`cov_time_point`	timepoint at which the outcome measure was taken according to Covidence data extraction template timepoint
`time`	timepoint at which the outcome measure was taken as reported in the paper and listed in Covidence
`time_weeks`	timepoint at which the outcome measure was taken in weeks, relative to the final dosing session
`time_days`	timepoint at which the outcome measure was taken in days, relative to the final dosing session
`primary_timepoint`	describes if the timepoint listed was reported as or chosen as the primary timepoint (1 = yes, 0 = no)
`post_crossover`	describes if the timepoint listed corresponds to a time before crossover or after crossover (0 = before crossover, 1 = after crossover, NA = does not correspond to a crossover study design
`n_arm1`	number of participants in arm 1 (for endpoint studies)
`mean_arm1`	mean value in arm 1 (for endpoint studies)
`sd_arm1`	standard deviation of mean value in arm 1 (for endpoint studies)
`n_arm2`	number of participants in arm 2 (for endpoint studies)
`mean_arm2`	mean value in arm 2 (for endpoint studies)
`sd_arm2`	standard deviation of mean value in arm 2 (for endpoint studies)
`n_change_arm1`	number of participants in arm 1 (for change from baseline studies)
`mean_change_arm1`	mean value in arm 1 (for change from baseline studies)
`sd_change_arm1`	standard deviation of mean value in arm 1 (for change from baseline studies)
`n_change_arm2`	number of participants in arm 2 (for change from baseline studies)
`mean_change_arm2`	mean value in arm 2 (for change from baseline studies)
`sd_change_arm2`	standard deviation of mean value in arm 2 (for change from baseline studies)
`event_arm1`	number of events in arm 1 (for dichotomous outcomes)
`totaln_arm1`	total number of participants in arm 1 (for dichotomous outcomes)
`event_arm2`	number of events in arm 2 (for dichotomous outcomes)
`totaln_arm2`	total number of participants in arm 2 (for dichotomous outcomes)
`baseline_m_arm1`	mean value at baseline timepoint for arm 1
`baseline_sd_arm1`	standard deviation of mean value at baseline timepoint for arm 1
`baseline_n_arm1`	number of participants in arm 1 at baseline timepoint
`baseline_m_arm2`	mean value at baseline timepoint for arm 2
`baseline_sd_arm2`	standard deviation of mean value at baseline timepoint for arm 2
`baseline_n_arm2`	number of participants in arm 2 at baseline timempoint
`d1`	risk of bias rating for domain 1 (randomization process)
`d2`	risk of bias rating for domain 2 (deviations from intended interventions)
`d3`	risk of bias rating for domain 3 (missing outcome data)
`d4`	risk of bias rating for domain 4 (outcome measurement)
`d5`	risk of bias rating for domain 5 (selection of the reported result)
`rob`	overall risk of bias rating
`year`	year of study publication
`drug_arm1`	drug used in the first arm (see condition_arm1)
`drug_arm2`	drug or placebo used in the second arm (see condition_arm2)
`dose_arm1`	dose of the drug used in the first arm
`dose_arm2`	dose of the drug used in the second arm
`name_arm1`	name of the first arm as written in paper and specified in Covidence
`name_arm2`	name of the second arm as written in paper and specified in Covidence
`n_dosing_sessions`	number of doses participants received
`mean_age`	mean age of study participants at baseline
`percent_women`	percentage of female study participants
`diagnosis`	main diagnosis of study participants (trd = treatment-resistatnt depression, dep = major depressive disorder, cancer = cancer, aud = alcohol-use disorder
`target_group`	target group for intervention
`design`	methodological design of the study (crossover = crossover study, paralell = parallel-group study)
`blinding`	specifies whether the study was double-blind or not (open-label = open-label waitlist study, double-blind = double-blind study)
`doi`	DOI of the paper
`registration_number`	registration number of study in clinicalTrials.gov
`full_ref`	full citation of the paper
`.id`	row identification, comprised of study author and year of publication, outcome type, instrument, time, rating, condition_arm1, condition_arm2, multi_arm1, and multi_arm2, separated by underscores
`.g`	calculated Hedges' g score (for continuous outcomes)
`.ge_se`	calculated standard error of Hedges' g score (for continuous outcomes)
`.log_rr`	calculated log risk ratio (for dichotomous outcomes)
`.log_rr_se`	calculated standard error of log risk ratio (for dichotomous outcomes)
`.event_arm1`	calculated number of events in arm 1 (see event_arm1)
`.event_arm2`	calculated number of events in arm 2 (see event_arm2)
`.totaln_arm1`	calculated total number of participants in arm 1 (see totaln_arm1)
`.totaln_arm2`	calculated total number of participants in arm 2 (see totaln_arm2)

Study References

Grob, 2011: Grob, C., Danforth, A., Chopra, G., Hagerty, M., McKay, C., Halberstadt, A., & Greer, G. (2011). Pilot Study of Psilocybin Treatment for Anxiety in Patients With Advanced-Stage Cancer. ARCHIVES OF GENERAL PSYCHIATRY, 68(1), 71–78. https://doi.org/10.1001/archgenpsychiatry.2010.116
Griffiths, 2016: Griffiths, R. R., Johnson, M. W., Carducci, M. A., Umbricht, A., Richards, W. A., Richards, B. D., Cosimano, M. P., & Klinedinst, M. A. (2016). Psilocybin produces substantial and sustained decreases in depression and anxiety in patients with life-threatening cancer: A randomized double-blind trial. Journal of Psychopharmacology, 30(12), 1181–1197. https://doi.org/10.1177/0269881116675513
Ross, 2016: Ross, S., Bossis, A., Guss, J., Agin-Liebes, G., Malone, T., Cohen, B., Mennenga, S. E., Belser, A., Kalliontzi, K., Babb, J., Su, Z., Corby, P., & Schmidt, B. L. (2016). Rapid and sustained symptom reduction following psilocybin treatment for anxiety and depression in patients with life-threatening cancer: A randomized controlled trial. Journal of Psychopharmacology, 30(12), 1165–1180. https://doi.org/10.1177/0269881116675512
Carhart-Harris, 2021: Carhart-Harris, R., Giribaldi, B., Watts, R., Baker-Jones, M., Murphy-Beiner, A., Murphy, R., Martell, J., Blemings, A., Erritzoe, D., & Nutt, D. J. (2021). Trial of Psilocybin versus Escitalopram for Depression. New England Journal of Medicine, 384(15), 1402–1411. https://doi.org/10.1056/NEJMoa2032994
Davis, 2021: Davis, A. K., Barrett, F. S., May, D. G., Cosimano, M. P., Sepeda, N. D., Johnson, M. W., Finan, P. H., & Griffiths, R. R. (2021). Effects of Psilocybin-Assisted Therapy on Major Depressive Disorder: A Randomized Clinical Trial. JAMA Psychiatry, 78(5), 481–489. https://doi.org/10.1001/jamapsychiatry.2020.3285
Goodwin, 2022: Goodwin Guy M., Aaronson Scott T., Alvarez Oscar, Arden Peter C., Baker Annie, Bennett James C., Bird Catherine, Blom Renske E., Brennan Christine, Brusch Donna, Burke Lisa, Campbell-Coker Kete, Carhart-Harris Robin, Cattell Joseph, Daniel Aster, DeBattista Charles, Dunlop Boadie W., Eisen Katherine, Feifel David, … Malievskaia Ekaterina. (2022). Single-Dose Psilocybin for a Treatment-Resistant Episode of Major Depression. New England Journal of Medicine, 387(18), 1637–1648. https://doi.org/10.1056/NEJMoa2206443
Krempien, 2023: Krempien, S., Inamdar, A., Shenouda, M., Johnson, K., Maass-Robinsin, S., Johnson, M., Kelman, A., Nathan, P., Belser, A., Pathare, P., House-Gecewicz, A., Sorie, A., Bartlone, A., Varty, G., Morgan, M., Avery, K., Muhammad, A., Nivorozhkin, A., & Palfreyman, M. (2023). Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of CYB003, a Deuterated Psilocybin Analog in Patients With Major Depressive Disorder. NEUROPSYCHOPHARMACOLOGY, 48, 195–196.
von Rotz, 2023: von Rotz, R., Schindowski, E. M., Jungwirth, J., Schuldt, A., Rieser, N. M., Zahoranszky, K., Seifritz, E., Nowak, A., Nowak, P., Jäncke, L., Preller, K. H., & Vollenweider, F. X. (2023). Single-dose psilocybin-assisted therapy in major depressive disorder: A placebo-controlled, double-blind, randomised clinical trial. eClinicalMedicine, 56. https://doi.org/10.1016/j.eclinm.2022.101809
Raison, 2023: Raison, C. L., Sanacora, G., Woolley, J., Heinzerling, K., Dunlop, B. W., Brown, R. T., Kakar, R., Hassman, M., Trivedi, R. P., Robison, R., Gukasyan, N., Nayak, S. M., Hu, X., O’Donnell, K. C., Kelmendi, B., Sloshower, J., Penn, A. D., Bradley, E., Kelly, D. F., … Griffiths, R. R. (2023). Single-Dose Psilocybin Treatment for Major Depressive Disorder: A Randomized Clinical Trial. JAMA, 330(9), 843–853. https://doi.org/10.1001/jama.2023.14530
Back, 2024: Back, A. L., Freeman-Young, T. K., Morgan, L., Sethi, T., Baker, K. K., Myers, S., McGregor, B. A., Harvey, K., Tai, M., Kollefrath, A., Thomas, B. J., Sorta, D., Kaelen, M., Kelmendi, B., & Gooley, T. A. (2024). Psilocybin Therapy for Clinicians With Symptoms of Depression From Frontline Care During the COVID-19 Pandemic: A Randomized Clinical Trial. JAMA Network Open, 7(12), e2449026. https://doi.org/10.1001/jamanetworkopen.2024.49026
Rosenblat, 2024: Rosenblat, J. D., Meshkat, S., Doyle, Z., Kaczmarek, E., Brudner, R. M., Kratiuk, K., Mansur, R. B., Schulz-Quach, C., Sethi, R., Abate, A., Ali, S., Bawks, J., Blainey, M. G., Brietzke, E., Cronin, V., Danilewitz, J., Dhawan, S., Di Fonzo, A., Di Fonzo, M., … McIntyre, R. S. (2024). Psilocybin-assisted psychotherapy for treatment resistant depression: A randomized clinical trial evaluating repeated doses of psilocybin. Med, 5(3), 190-200.e5. https://doi.org/10.1016/j.medj.2024.01.005
Rieser, 2025: Rieser, N. M., Bitar, R., Halm, S., Rossgoderer, C., Gubser, L. P., Thévenaz, M., Kreis, Y., Rotz, R. von, Nordt, C., Visentini, M., Moujaes, F., Engeli, E. J. E., Ort, A., Seifritz, E., Vollenweider, F. X., Herdener, M., & Preller, K. H. (2025). Psilocybin-assisted therapy for relapse prevention in alcohol use disorder: A phase 2 randomized clinical trial. eClinicalMedicine, 82. https://doi.org/10.1016/j.eclinm.2025.103149

Database Flowchart

Studies in the depression-psiloctr dataset were extracted from the larger Sypres collaboration database. The study flow of this database can be found below.

Re-analysis/Secondary report: n=35
Not an RCT: n=11
Conference abstract - full text already included: n=6
Wrong outcomes/no mood outcomes: n=7
Protocol/incomplete study: n=3
non-English language: n=3
Wrong patient population: n=3
Preprint/conference poster: n=2

Citation