What this phase means
Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Psilocybin 25 mg per os, Trazodone 5mg, or Trazodone 30 mg. The registry lists allocation as randomized. Psilocybin, a serotonin receptor agonist in the brain, significantly and quickly improves depressive symptoms while inducing profound acute subjective effects.
They plan to enroll about 112 people at Paris. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
Efficacy of Psilocybin and Trazodone Combination in Treatment-resistant Depression: a Randomized Controlled Proof-of-concept Study (PSILOTRAZ)
Interventions: Psilocybin 25 mg per os, Trazodone 5mg, Trazodone 30 mg, Placebo of psilocybin, Placebo of trazodone
Primary outcome (registry wording): Change from Baseline in the mean score of Montgomery-Åsberg Depression Rating Scale (MADRS) at 1 month