Clinical trial methodology

Methodological challenges in psychedelic drug trials: Efficacy and safety of psilocybin in treatment-resistant major depression (EPIsoDE) – Rationale and study design

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This research paper describes a major clinical trial testing whether psilocybin (the active compound in magic mushrooms) can treat depression that doesn’t respond to standard medications. The trial involves 144 patients receiving either psilocybin at different doses or a placebo in a carefully controlled medical setting with psychological support. The researchers developed special methods to address unique challenges in psychedelic research, such as making it difficult for patients to guess whether they received the active drug, and ensuring all patients eventually get access to the potentially helpful treatment.

Psychedelic-assisted therapy – supposedly paradigm-shifting research with poor attempts at hypotheses falsifying and questionable ethics

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This paper critically examines recent clinical trials testing MDMA and psilocybin for treating PTSD and depression. While these trials reported promising results, the author identifies serious scientific and ethical problems: participants could tell whether they received the drug or placebo due to its strong effects, researchers and therapists who strongly believed in the treatment may have unconsciously influenced patient responses, and negative side effects may have been downplayed. The author argues that without fixing these problems, the entire field of psychedelic therapy research could lose credibility.

Research Topic: Clinical trial methodology

Methodological challenges in psychedelic drug trials: Efficacy and safety of psilocybin in treatment-resistant major depression (EPIsoDE) – Rationale and study design

Psychedelic-assisted therapy – supposedly paradigm-shifting research with poor attempts at hypotheses falsifying and questionable ethics