Clinical Trial

Efficacy of Psilocybin and Trazodone Combination in Treatment-resistant Depression: a Randomized Controlled Proof-of-concept Study (PSILOTRAZ)

Study acronym: PSILOTRAZ
Not Yet Recruiting Phase 2
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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.
Trial Details
NCT Number NCT07210112
Lead Sponsor Centre Hospitalier St Anne
Conditions Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
Enrollment 112 participants
Start Date 2025-10-08
Primary Completion 2029-12-31 (estimated)
Study Completion 2030-06-30 (estimated)
Updated on ClinicalTrials.gov 2025-10-07