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A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder

Study acronym: EMBRACE
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 months later Mar 18, 2027 → Jun 7, 2027
See other at-risk trials from Cybin IRL Limited

Record History

  1. Site details revised at 6 of 79 sites
  2. Primary completion pushed from Mar 18, 2027 to Jun 7, 2027 Trial sites expanded: 69 → 79 locations · Completion pushed from May 8, 2027 to Aug 9, 2027 · Eligibility criteria expanded, about 29 words · 1 more Show 4 more changesShow less
    • Trial sites expanded: 69 → 79 locations
    • Completion pushed from May 8, 2027 to Aug 9, 2027
    • Eligibility criteria expanded, about 29 words
    • Secondary endpoints: details revised at 4 of 4 entries
  3. Study sites: 68 to 69v35
  4. Site details revised at 5 of 68 sitesv34
  5. Study sites revised (68)v33 See this version in full on ClinicalTrials.gov ↗
Show 31 earlier versionsHide 31 earlier versions
  1. Site details revised at 2 of 68 sitesv32
  2. Site contacts updated at 1 of 68 sitesv31
  3. Site details revised at 1 of 68 sitesv30
  4. Study sites: 67 to 68v29
  5. Site details revised at 2 of 67 sitesv28
  6. Re-verified, no change to tracked fieldsv27
  7. Site details revised at 1 of 67 sitesv26
  8. Site contacts updated at 1 of 67 sitesv25
  9. Site details revised at 3 of 67 sitesv24
  10. Eligibility criteria expanded, about 75 words Site details revised at 13 of 67 sitesv23 Show 1 more changeShow less
    • Site details revised at 13 of 67 sites

    See this version in full on ClinicalTrials.gov ↗

  11. Eligibility criteria expanded, about 239 words Site details revised at 4 of 67 sitesv22 Show 1 more changeShow less
    • Site details revised at 4 of 67 sites

    See this version in full on ClinicalTrials.gov ↗

  12. Site details revised at 2 of 67 sitesv21
  13. Site details revised at 2 of 67 sitesv20
  14. Site details revised at 2 of 67 sitesv19
  15. Study sites revised (67)v18 See this version in full on ClinicalTrials.gov ↗
  16. Study sites revised (67)v17 See this version in full on ClinicalTrials.gov ↗
  17. Site details revised at 5 of 67 sitesv16
  18. Site details revised at 2 of 67 sitesv15
  19. Site details revised at 20 of 67 sitesv14
  20. Site contacts updated at 1 of 67 sitesv13
  21. Re-verified, no change to tracked fieldsv12
  22. Site details revised at 1 of 67 sitesv11
  23. Site contacts updated at 1 of 67 sitesv10
  24. Site details revised at 2 of 67 sitesv9
  25. Site details revised at 1 of 67 sitesv8
  26. Site details revised at 3 of 67 sitesv7
  27. Study sites: 58 to 67v6
  28. Study sites: 45 to 58 Start date changed from estimate of Nov 30, 2025 to Dec 10, 2025v5 Show 1 more changeShow less
    • Start date changed from estimate of Nov 30, 2025 to Dec 10, 2025
  29. Trial status: Not Yet Recruiting to Recruiting Start date: Oct 8, 2025 to Nov 30, 2025 · Site details revised at 45 of 45 sitesv4 Show 2 more changesShow less
    • Start date: Oct 8, 2025 to Nov 30, 2025
    • Site details revised at 45 of 45 sites
  30. Start date: Jul 8, 2025 to Oct 8, 2025 Study sites: 0 to 45v3 Show 1 more changeShow less
    • Study sites: 0 to 45
  31. Secondary endpoints: details revised at 4 of 4 entries Study title expanded, about 3 wordsv2 Show 1 more changeShow less
    • Study title expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Cybin IRL Limited
4 trials monitored
See 2 trials at risk
Depression
2,998 trials monitored
See 166 trials at risk
The purpose of this study is to determine the efficacy, safety and tolerability of CYB003 compared to matching placebo as adjunctive treatment in patients with MDD. For more information about the EMBRACE study, including participating study locations, and to register your interest in learning more about participation, please visit the study website: https://embrace-mdd-trial.com/
Trial Details
NCT Number NCT06793397
Lead Sponsor Cybin IRL Limited
Collaborators: Worldwide Clinical Trials
Conditions Major Depressive Disorder (MDD), Depression in Adults, Depression - Major Depressive Disorder, Depression Disorders, Depression Disorder, Depression
Enrollment 330 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov