Loading
Life sciences · Phase 3 Trial
ClinicalTrials.gov · October 21, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Phase 3 Trial.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
The source did not state who this applies to in practice.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
This record has not been graded across any dimension yet. Treat the label above as provisional and read the source.
What is missing. This record has no bottom line, key findings, reported figures, evidence dimensions. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT06308653). This is a study registration, not published results. Lead sponsor: Usona Institute. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 238 participants (ACTUAL). Conditions: Depressive Disorder, Major. Interventions: DRUG: Psilocybin 25 mg; DRUG: Inactive Placebo; DRUG: Psilocybin 5 mg; BEHAVIORAL: Psychosocial Support. Primary outcome measures: Change in central rater Montgomery-Asberg Depression Rating Scale (MADRS) total score from Baseline to Trial Day 43 , From Trial Baseline to Trial Day 43. Brief summary: Approximately 240 eligible adult participants (≥18 years old) who meet Diagnostic and Statistical Manual of Mental Disorders (DSM-5-TR) criteria for Major Depressive Disorder (MDD) will be enrolled. Participants will be randomly assigned to receive a single oral dose of Psilocybin 25 mg, Psilocybin 5 mg, or inactive placebo. The purpose of this study is to evaluate the efficacy, safety, and tolerability of Psilocybin 25 mg versus placebo in adults with MDD, as assessed by the difference between groups in change in depressive symptoms from Baseline to Day 43 post-dose, and to characterize the durability of initial treatment effect and subsequent response to optional Psilocybin 25 mg re-administration(s) during the 1-year Follow-up Period.