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Life sciences · Phase 3 Trial
ClinicalTrials.gov · September 23, 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.
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Registry record from ClinicalTrials.gov (NCT06605105). This is a study registration, not published results. Lead sponsor: Cybin IRL Limited. Recruitment status: ENROLLING_BY_INVITATION. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 468 participants (ESTIMATED). Conditions: Major Depressive Disorder. Interventions: DRUG: CYB003. Primary outcome measures: Montgomery-Asberg Depression Rating Scale (MADRS) , Baseline, Day 28, Day 56, Day 84, Day 112, Day 140, Day 168, Day 196, Day 244, Day 252, Day 280, Day 301; additional assessments at Day -15, Day -1, Day 2, Day 10, Day 17, Day 21, Day 23, Day 31, Day 42 if non-response or relapse criteria met. Brief summary: This is a long- term extension of the double-blind trials APPROACH (CYB003-002) and EMBRACE (CYB003-003). Its aim is to examine the safety and long-term efficacy of CYB003 in participants with MDD.