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

Study acronym: APPROACH
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date changed from estimate of Aug 2026 to Sep 4, 2026 Completion date: Sep 2026 to Oct 2026 · Eligibility criteria expanded, about 34 words · Secondary endpoints: details revised at 2 of 4 entries · 1 more Show 4 more changesShow less
    • Completion date: Sep 2026 to Oct 2026
    • Eligibility criteria expanded, about 34 words
    • Secondary endpoints: details revised at 2 of 4 entries
    • Site details revised at 2 of 45 sites
  2. Enrollment closed, study ongoing Study sites: 47 to 45v28 Show 1 more changeShow less
    • Study sites: 47 to 45
  3. Site details revised at 1 of 47 sitesv27
  4. Study sites: 46 to 47v26
  5. Study sites: 47 to 46 Eligibility criteria shortened, about 4 wordsv25 Show 1 more changeShow less
    • Eligibility criteria shortened, about 4 words

    See this version in full on ClinicalTrials.gov ↗

Show 23 earlier versionsHide 23 earlier versions
  1. Site details revised at 1 of 47 sitesv24
  2. Study sites revised (47)v23 See this version in full on ClinicalTrials.gov ↗
  3. Study sites: 45 to 47 Eligibility criteria expanded, about 52 wordsv22 Show 1 more changeShow less
    • Eligibility criteria expanded, about 52 words

    See this version in full on ClinicalTrials.gov ↗

  4. Study sites revised (45)v21 See this version in full on ClinicalTrials.gov ↗
  5. Site details revised at 3 of 45 sitesv20
  6. Site details revised at 1 of 45 sitesv19
  7. Site details revised at 1 of 45 sitesv18
  8. Site details revised at 1 of 45 sitesv17
  9. Study sites revised (45)v16 See this version in full on ClinicalTrials.gov ↗
  10. Site details revised at 8 of 45 sitesv15
  11. Study sites: 44 to 45 Collaborators shortened, about 3 wordsv14 Show 1 more changeShow less
    • Collaborators shortened, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  12. Start date: Nov 15, 2024 to Dec 17, 2024 Primary completion date: Mar 2026 to Aug 2026 · Completion date: May 2026 to Sep 2026v13 Show 2 more changesShow less
    • Primary completion date: Mar 2026 to Aug 2026
    • Completion date: May 2026 to Sep 2026
  13. Study sites: 45 to 44v12
  14. Study sites: 44 to 45v11
  15. Study sites: 25 to 44v10
  16. Re-verified, no change to tracked fieldsv9
  17. Site details revised at 25 of 25 sitesv8
  18. Site details revised at 3 of 25 sitesv7
  19. Study sites: 26 to 25v6
  20. Site details revised at 25 of 26 sites Study title expanded, about 1 wordv5 Show 1 more changeShow less
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  21. Study sites: 5 to 26v4
  22. Study sites: 1 to 5 Start date changed from estimate of Nov 2024 to Nov 15, 2024 · Eligibility criteria shortened, about 473 wordsv3 Show 2 more changesShow less
    • Start date changed from estimate of Nov 2024 to Nov 15, 2024
    • Eligibility criteria shortened, about 473 words

    See this version in full on ClinicalTrials.gov ↗

  23. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1v2 Show 1 more changeShow less
    • Study sites: 0 to 1
  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 examine the efficacy, safety, and tolerability of CYB003 compared to matching placebo as adjunctive treatment in participants with MDD.
Trial Details
NCT Number NCT06564818
Lead Sponsor Cybin IRL Limited
Conditions Major Depressive Disorder
Enrollment 220 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov