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Phase III Long-term Extension Trial to Assess Safety and Efficacy of CYB003 in MDD (EXTEND)

Study acronym: EXTEND
StatusEnrolling by Invitation
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 months later Mar 15, 2028 → Jun 6, 2028
See other at-risk trials from Cybin IRL Limited

Record History

  1. Primary and study completion pushed from Mar 15, 2028 to Jun 6, 2028 Trial sites expanded: 33 → 49 locations Show 1 more changeShow less
    • Trial sites expanded: 33 → 49 locations
  2. Study sites: 33 to 49 Eligibility criteria expanded, about 13 words Show 1 more changeShow less
    • Eligibility criteria expanded, about 13 words
  3. Trial sites expanded: 19 → 33 locationsv8
  4. Trial status: Recruiting to Enrolling by Invitation Study sites: 10 to 19v7 Show 1 more changeShow less
    • Study sites: 10 to 19
  5. Study sites: 4 to 10v6
Show 4 earlier versionsHide 4 earlier versions
  1. Study sites: 2 to 4v5
  2. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 2 · Start date changed from estimate of Jul 15, 2025 to Jul 18, 2025v4 Show 2 more changesShow less
    • Study sites: 0 to 2
    • Start date changed from estimate of Jul 15, 2025 to Jul 18, 2025
  3. Start date: May 7, 2025 to Jul 15, 2025 Primary and study completion dates: Jan 15, 2028 to Mar 15, 2028 · Eligibility criteria expanded, about 218 wordsv3 Show 2 more changesShow less
    • Primary and study completion dates: Jan 15, 2028 to Mar 15, 2028
    • Eligibility criteria expanded, about 218 words

    See this version in full on ClinicalTrials.gov ↗

  4. Enrollment target: 220 to 468 Start date: Feb 23, 2025 to May 7, 2025 · Primary and study completion dates: Sep 6, 2027 to Jan 15, 2028 · Eligibility criteria expanded, about 32 wordsv2 Show 3 more changesShow less
    • Start date: Feb 23, 2025 to May 7, 2025
    • Primary and study completion dates: Sep 6, 2027 to Jan 15, 2028
    • Eligibility criteria expanded, about 32 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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
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.
Trial Details
NCT Number NCT06605105
Lead Sponsor Cybin IRL Limited
Collaborators: Worldwide Clinical Trials
Conditions Major Depressive Disorder
Enrollment 468 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov