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Life sciences · Phase 2 Trial
ClinicalTrials.gov · September 21, 2026
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Phase 2 Trial.
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Registry record from ClinicalTrials.gov (NCT07210112). This is a study registration, not published results. Lead sponsor: Centre Hospitalier St Anne. Recruitment status: RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 112 participants (ESTIMATED). Conditions: Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD). Interventions: DRUG: Psilocybin 25 mg per os; DRUG: Trazodone 5mg; DRUG: Trazodone 30 mg; DRUG: Placebo of psilocybin; DRUG: Placebo of trazodone. Primary outcome measures: Change from Baseline in the mean score of Montgomery-Åsberg Depression Rating Scale (MADRS) at 1 month , Baseline, Month 1. Brief summary: Psilocybin, a serotonin receptor agonist in the brain, significantly and quickly improves depressive symptoms while inducing profound acute subjective effects. The benefit-risk ratio of psilocybin in treatment-resistant depression seems favorable, but needs to be confirmed. Moreover, the role of 5-HT2A receptors, involved in the psychedelic experience, on the therapeutic efficacy of psilocybin is still poorly understood. For example, pre-administration of trazodone, a 5-HT2A antagonist antidepressant, could annihilate the acute subjective effects of psilocybin without altering its beneficial effects (Rosenblat et al., 2023). We intend to test this hypothesis by comparing, in a randomized, double-blind, placebo-controlled study, the effect of two possible doses of trazodone (total or partial occupancy of 5-HT2A receptors) on the benefit/risk ratio of psilocybin. We hypothesize that the therapeutic effects of psilocybin are partially independent of 5-HT2A receptor activation and thus persist even after total or partial neutralization of its acute subjective effects.