Methodological challenges in psychedelic drug trials: Efficacy and safety of psilocybin in treatment-resistant major depression (EPIsoDE) – Rationale and study design
Open accessAbstract
Psychedelics such as psilocybin have recently gained remarkable interest in both the specialist literature and the lay press because studies suggest that these substances may have great therapeutic potential in various psychiatric disorders, including major depression. However, clinical trials with psychedelic drugs pose particular methodological challenges to researchers, some of which differ considerably from those with other psychotropic drugs. These include the problem of successful blinding, which can hardly be guaranteed in clinical trials with psychedelic substances and - directly related - the high risk of expectation bias and nocebo effects. Some of these challenges are being addressed in the given clinical trial on the efficacy and safety of psilocybin in treatment-resistant major depression. It is a phase II randomized, double-blind, active placebo-controlled parallel group trial with 144 patients. The rationale, the study design, and the core features of the study are presented here. The trial (EPIsoDE trial; EudraCT number: 2019-003984-24; NCT04670081) is funded by the German Federal Ministry of Education and Research (BMBF 01EN2006 A/B).
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Koslowski, M. (2026) · Elsevier eBooks · doi:10.1016/b978-3-437-21293-2.00012-5
Self-citationDepression und andere affektive Erkrankungen
Mertens, L. J., & Spangemacher, M. (2026) · Elsevier eBooks · doi:10.1016/b978-3-437-21293-2.00011-3
Self-citation
- Authors
- Mertens, L. J., Koslowski, M., Betzler, F., Evens, R., Gilles, M., Jungaberle, A., Jungaberle, H., Majić, T., Ströhle, A., Wolff, M., Wellek, S., & Gründer, G.
- Affiliations
- Heidelberg University (DE)
- Humboldt-Universität zu Berlin (DE)
- Corresponding author
- Mertens, Lea J.
- ORCID
- Venue
- Neuroscience Applied
- Publisher
- Elsevier BV
- Published
- 2022
- Volume
- 1
- Pages
- 100104
- ISSN
- 2772-4085 (ISSN-L)
- PMC
- PMC12244097
- OpenAlex
- W4220708535
- Cited by
- 41
- References
- 51
- Citations by year
- 2026: 9 · 2025: 7 · 2024: 16 · 2023: 7 · 2022: 2
- FWCI
- 7.30
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- Neuroscience Applied (publishedVersion, cc-by-nc-nd)
- PubMed Central (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- Funders
- Bundesministerium fur Bildung und Forschung Dienststelle Berlin
- Bundesministerium für Bildung und Forschung (01EN2006A/B)
- Topics
- Social Sciences › Psychology › Clinical Psychology › Psychedelics and Drug Studies
- Health Sciences › Medicine › Pharmacology › Treatment of Major Depression
- Life Sciences › Neuroscience › Cognitive Neuroscience › Pain Management and Placebo Effect
- Keywords
- psilocybin, psychedelics, clinical trial design, blinding, expectation bias, nocebo effect, antidepressant efficacy, drug safety
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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