Efficacy, all-cause discontinuation, and safety of serotonergic psychedelics and MDMA to treat mental disorders: a living systematic review with meta-analysis

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dc.authorid0000-0002-5786-5203
dc.authorid0000-0002-6009-1085
dc.authorid0000-0002-0058-6860
dc.authorid0000-0003-3582-6788
dc.authorid0000-0002-7254-5646
dc.authorid0000-0001-5877-8075
dc.authorid0000-0003-2057-4071
dc.authorid0000-0002-9767-2270
dc.authorid0000-0002-5554-6946
dc.authorid0000-0001-5771-5750
dc.authorid0000-0002-4773-2191
dc.authorid0000-0002-7316-5370
dc.authorid0000-0003-3117-2350
dc.authorid0000-0002-7405-0954
dc.authorid0000-0001-5179-8321
dc.authorid0000-0003-1133-9344
dc.authorid0000-0002-6062-7150
dc.authorid0000-0002-4409-0795
dc.authorid0000-0002-8038-300X
dc.authorid0000-0002-6873-5105
dc.authorid0000-0003-2434-4206
dc.authorid0000-0002-0645-4869
dc.authorid0000-0003-0485-9069
dc.authorid0000-0003-1240-5438
dc.authorid0000-0002-0548-0053
dc.authorid0000-0001-7303-2458
dc.authorid0000-0001-6388-4825
dc.authorid0000-0003-4877-7233
dc.contributor.authorHøjlund, Mikkelen_US
dc.contributor.authorYılmaz Kafalı, Helinen_US
dc.contributor.authorKırmızı, Begümen_US
dc.contributor.authorFusar-Poli, Paoloen_US
dc.contributor.authorCorrell, Christoph U.en_US
dc.contributor.authorCortese, Samueleen_US
dc.contributor.authorSabé, Michelen_US
dc.contributor.authorFiedorowicz, Jessen_US
dc.contributor.authorSaraf, Gayatrien_US
dc.contributor.authorZein, Josephineen_US
dc.contributor.authorBerk, Michaelen_US
dc.contributor.authorHusain, Muhammad I.en_US
dc.contributor.authorRosenblat, Joshua D.en_US
dc.contributor.authorRubaiyat, Rubyen_US
dc.contributor.authorCorace, Kimen_US
dc.contributor.authorWong, Stanleyen_US
dc.contributor.authorHatcher, Simonen_US
dc.contributor.authorKaluzienski, Marken_US
dc.contributor.authorYatham, Lakshmi N.en_US
dc.contributor.authorCipriani, Andreaen_US
dc.contributor.authorGosling, Corentin J.en_US
dc.contributor.authorCarhart-Harris, Robinen_US
dc.contributor.authorTanuseputro, Peteren_US
dc.contributor.authorMyran, Daniel T.en_US
dc.contributor.authorFabiano, Nicholasen_US
dc.contributor.authorMoher, Daviden_US
dc.contributor.authorMayo, Leah M.en_US
dc.contributor.authorNicholls, Stuart G.en_US
dc.contributor.authorWhite, Tracyen_US
dc.contributor.authorPrisco, Michele Deen_US
dc.contributor.authorRadua, Joaquimen_US
dc.contributor.authorVieta, Eduarden_US
dc.contributor.authorLadha, Karim S.en_US
dc.contributor.authorKatz, Jayen_US
dc.contributor.authorVeroniki, Areti A.en_US
dc.contributor.authorSolmi, Marcoen_US
dc.date.accessioned2025-11-21T08:44:31Z
dc.date.available2025-11-21T08:44:31Z
dc.date.issued2025-12
dc.departmentIşık Üniversitesi, İktisadi, İdari ve Sosyal Bilimler Fakültesi, Psikoloji Bölümüen_US
dc.departmentIşık University, Faculty of Economics, Administrative and Social Sciences, Department of Psychologyen_US
dc.description.abstractSerotonergic psychedelics and 3,4-methylendioxtmethamphetamine (MDMA) are promising treatments for mental disorders with a continuously evolving evidence base. We searched Pubmed/Scopus/clinical trial registries up to 08july2025 for double-blind randomized controlled trials (RCTs) testing MDMA or serotonergic psychedelics in patients with mental disorders. Primary outcomes were change in disease-specific symptoms and all-cause discontinuation. Standardized mean differences (SMD) and relative risk (RR) were estimated using random-effects meta-analysis. Risk of bias (RoB) was assessed with Cochrane’s RoB-tool version 2 and certainty of evidence with GRADE. The review is maintained as living systematic review ( https://ebipsyche-database.org/ ). We included 30 RCTs (1480 participants; female=45.8 %; with psychological support=83.3 %; high RoB=83.3 %). In post-traumatic stress disorder (PTSD), MDMA reduced PTSD symptoms compared to any control ( k = 11; SMD=-0.85 [-1.09; -0.60]; I2=0 %; GRADE=low). In major depressive disorder (MDD), psilocybin/ayahuasca/LSD reduced depressive symptoms ( k = 8; SMD=-0.62 [-0.97; -0.28]; I2=55 %; GRADE=very low). In anxiety disorders, both MDMA and serotonergic psychedelics reduced anxiety symptoms (SMDMDMA=-1.18 [-2.04; -0.32]; I2=0 %; k = 2; GRADE=low and SMDserotonergic=-0.88 [-1.70; -0.06]; I2=54 %; k = 5; GRADE=very low). In alcohol use disorder, neither psilocybin nor LSD reduced abstinence rates ( k = 6; RR=1.42 [0.89; 2.26]; I2=7 %; GRADE=very low). In attention-deficit hyperactivity disorder (ADHD), LSD did not reduce ADHD symptoms ( k = 1; SMD=0.22 [-0.32; 0.76]; GRADE=very low). Moderate certainty in evidence was only found for MDMA on PTSD symptoms when compared to placebo. MDMA/serotonergic psychedelics were not associated with higher risk of all-cause discontinuation (RRMDMA=0.74 [0.32; 1.72]; RRserotonergic=0.81 [0.56; 1.15]). Overall, MDMA/serotonergic psychedelics are promising for the treatment of PTSD, MDD, and anxiety disorders with moderate to large effect sizes. Pragmatic trials, long-term, head-to-head trials exploring the role of psychological support, aiming to identify predictors of response, and accounting for expectancy and functional unblinding are needed. Studies addressing these limitations will likely be required for regulatory approval of psychedelic drugs.en_US
dc.description.versionPublisher's Versionen_US
dc.identifier.citationHøjlund, M., Yılmaz Kafalı, H., Kırmızı, B., Fusar-Poli, P., Correll, C. U., Cortese, S., Sabé, M., Fiedorowicz, J., Saraf, G., Zein, J., Berk, M., Husain, M. I., Rosenblat, J. D., Rubaiyat, R., Corace, K., Wong, S., Hatcher, S., Kaluzienski, M., Yatham, L. N., Cipriani, A., Gosling, C. J., Carhart-Harris, R., Tanuseputro, P., Myran, D. T., Fabiano, N., Moher, D., Mayo, L. M., Nicholls, S. G., White, T., De Prisco, M., Radua, J., Vieta, E., Ladha, K. S., Katz, J., Veroniki, A. A. & Solmi, M. (2025). Efficacy, all-cause discontinuation, and safety of serotonergic psychedelics and MDMA to treat mental disorders: A living systematic review with meta-analysis. European Neuropsychopharmacology, 101, 41–55. doi:https://doi.org/10.1016/j.euroneuro.2025.09.011en_US
dc.identifier.doi10.1016/j.euroneuro.2025.09.011
dc.identifier.endpage55
dc.identifier.issn0924-977X
dc.identifier.issn1873-7862
dc.identifier.pmid41205366
dc.identifier.scopus2-s2.0-105021115167
dc.identifier.scopusqualityQ1
dc.identifier.startpage41
dc.identifier.urihttps://hdl.handle.net/11729/6789
dc.identifier.urihttps://doi.org/10.1016/j.euroneuro.2025.09.011
dc.identifier.volume101
dc.identifier.wosWOS:001615773000001
dc.identifier.wosqualityQ1
dc.indekslendigikaynakScopusen_US
dc.indekslendigikaynakPubMeden_US
dc.indekslendigikaynakWeb of Science
dc.indekslendigikaynakScience Citation Index Expanded (SCI-EXPANDED)
dc.institutionauthorYılmaz Kafalı, Helinen_US
dc.institutionauthorid0000-0002-6009-1085
dc.language.isoenen_US
dc.peerreviewedYesen_US
dc.publicationstatusPublisheden_US
dc.publisherElsevier B.V.en_US
dc.relation.ispartofEuropean Neuropsychopharmacologyen_US
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanıen_US
dc.rightsinfo:eu-repo/semantics/openAccessen_US
dc.subjectAyahuascaen_US
dc.subjectLysergic acid diethylamideen_US
dc.subjectMeta-analysisen_US
dc.subjectN-methyl-3en_US
dc.subject4-methylenedioxyamphetamineen_US
dc.subjectPsilocybinen_US
dc.subjectPsychedelicsen_US
dc.subjectDexamphetamineen_US
dc.subjectDiphenhydramineen_US
dc.subjectEphedrineen_US
dc.subjectEscitalopramen_US
dc.subjectlysergideen_US
dc.subjectMidomafetamineen_US
dc.subjectNicotinic aciden_US
dc.subjectPlaceboen_US
dc.subjectPsilocybineen_US
dc.subjectPsychedelic agenten_US
dc.subjectSerotonin uptake inhibitoren_US
dc.subjectAdjustment disorderen_US
dc.subjectAlcoholismen_US
dc.subjectAnxiety disorderen_US
dc.subjectAppetite disorderen_US
dc.subjectArticleen_US
dc.subjectAstheniaen_US
dc.subjectAttention deficit hyperactivity disorderen_US
dc.subjectAutismen_US
dc.subjectBanisteriopsis caapien_US
dc.subjectBronchitisen_US
dc.subjectDepersonalizationen_US
dc.subjectDiarrheaen_US
dc.subjectDizzinessen_US
dc.subjectDrug dose comparisonen_US
dc.subjectDrug withdrawalen_US
dc.subjectDysthymiaen_US
dc.subjectEmotional disorderen_US
dc.subjectEmotional stressen_US
dc.subjectFatigueen_US
dc.subjectFemaleen_US
dc.subjectFunctional diseaseen_US
dc.subjectGait disorderen_US
dc.subjectGeneralized anxiety disorderen_US
dc.subjectHeadacheen_US
dc.subjectHumanen_US
dc.subjectHyperhidrosisen_US
dc.subjectIllusionen_US
dc.subjectInsomniaen_US
dc.subjectMajor depressionen_US
dc.subjectMaleen_US
dc.subjectMental diseaseen_US
dc.subjectMeta analysisen_US
dc.subjectMigraineen_US
dc.subjectMuscle strainen_US
dc.subjectNauseaen_US
dc.subjectOropharynx painen_US
dc.subjectPhotosensitivityen_US
dc.subjectPosttraumatic stress disorderen_US
dc.subjectPsychological careen_US
dc.subjectPsychotherapyen_US
dc.subjectRestlessnessen_US
dc.subjectSocial phobiaen_US
dc.subjectSomnolenceen_US
dc.subjectSuicidal ideationen_US
dc.subjectSystematic reviewen_US
dc.subjectTension headacheen_US
dc.subjectVomitingen_US
dc.titleEfficacy, all-cause discontinuation, and safety of serotonergic psychedelics and MDMA to treat mental disorders: a living systematic review with meta-analysisen_US
dc.typeArticleen_US
dspace.entity.typePublicationen_US

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