ArticleNeuroscience applied2022
Methodological challenges in psychedelic drug trials: Efficacy and safety of psilocybin in treatment-resistant major depression (EPIsoDE) - Rationale and study design.
Article in Neuroscience applied, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04670081 (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), which is not on this map. Cited by 16 papers, 2 of them syntheses that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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
Who cites it
16 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Anxiety and Affective Symptoms Related to the Use of Classic Psychedelics: A Systematic Review.Current topics in behavioral neurosciences · 2026Pooled it
- Catalyst for change: Psilocybin's antidepressant mechanisms-A systematic review.Journal of psychopharmacology (Oxford, England) · 2025Pooled it
- Efficacy and Safety of Psilocybin in Treatment-Resistant Major Depression: The EPISODE Randomized Clinical Trial.JAMA psychiatry · 2026Trial
- Induction of altered states of consciousness during Floatation-REST is associated with the dissolution of body boundaries and the distortion of subjective time.Scientific reports · 2024Trial
- Long-Term Efficacy of Psilocybin with Adjunct Psychotherapy in Treatment-Resistant Major Depression: 6- and 12-Month Naturalistic Follow-Up of a Phase 2b Trial.Psychotherapy and psychosomatics · 2026Article
- Current perspectives on psychedelic treatments in Europe.The Lancet regional health. Europe · 2026Review
- Synergies in psychedelic-assisted therapy: a qualitative interview study of psychotherapeutic processes.Frontiers in psychiatry · 2026Article
- Epistemic Risk Reduction in Psychedelic-Assisted Therapy.Current topics in behavioral neurosciences · 2026Review
- [Acceptance of psilocybin-assisted therapy in German-speaking countries].Der Nervenarzt · 2025Article
- Psychedelic-Induced Neural Plasticity: A Comprehensive Review and a Discussion of Clinical Implications.Brain sciences · 2025Review
- Use of psychedelic treatments in psychiatric clinical practice: an EPA policy paper.European psychiatry : the journal of the Association of European Psychiatrists · 2025Article
- Psilocybin as a Disease-Modifying Drug—A Salutogenic Approach in Psychiatry.Deutsches Arzteblatt international · 2024Review
- Expert recommendations for Germany's integration of psychedelic-assisted therapy.BMC medical education · 2024Review
- [Psychedelic and dissociative agents in psychiatry: challenges in the treatment].Der Nervenarzt · 2024Review
- Article
- A Systematic Review of Study Design and Placebo Controls in Psychedelic Research.Psychedelic medicine (New Rochelle, N.Y.) · 2024Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
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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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.