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CYB003 / Major Depressive Disorder / Psychological Support · Phase 3 Trial
ClinicalTrials.gov · August 12, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 3 clinical trial registration for CYB003 (a deuterated psilocin analog) versus placebo in major depressive disorder, with MADRS as the primary outcome measured over 42 days. No efficacy or safety results have been posted to the registry record; the study is active but recruitment has closed.
Phase 3, Interventional, Randomized, Parallel, Quadruple masking, Treatment purpose. Major Depressive Disorder; age from 18 Years; to 85 Years. Intervention: Experimental Arm A: CYB003 in 2 of 2 Dosing Sessions. Compared with: Placebo Comparator Arm B: Placebo in 2 of 2 Dosing Sessions — Placebo Comparator. n = 220. 45 sites: United States.
This is a Phase 3 clinical trial registration for CYB003 (a deuterated psilocin analog) versus placebo in major depressive disorder, with MADRS as the primary outcome measured over 42 days. No efficacy or safety results have been posted to the registry record; the study is active but recruitment has closed.
No efficacy, safety, or tolerability results are posted in this registry record.
The source did not state who this applies to in practice.
This is a Phase 3 trial registration with no posted results; the study is active but not recruiting, so outcomes remain unreported in this registry record.
As stated by the source record.
Quoted from the source exactly as published.
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.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT06564818). This is a study registration, not published results. Lead sponsor: Cybin IRL Limited. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 220 participants (ESTIMATED). Conditions: Major Depressive Disorder. Interventions: DRUG: CYB003; BEHAVIORAL: Psychological Support; DRUG: Placebo. Primary outcome measures: Montgomery-Åsberg Depression Rating Scale (MADRS) , Screening Day-45, Baseline Day-1, Day 2, Day 10, Day 21, Day 23, Day 31, and Day 42 (End of Treatment). Brief summary: The purpose of this study is to examine the efficacy, safety, and tolerability of CYB003 compared to matching placebo as adjunctive treatment in participants with MDD.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.