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A Mechanistic Study to Assess a Single Dose of CYB003 in Participants With Depression and Anxiety

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 5 months later Mar 2027 → Sep 2028
See other at-risk trials from Ohio State University

Record History

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  1. Notable Primary completion pushed from Mar 2027 to Sep 2028v4 Show 4 more changesShow less
    • Recruitment opened
    • Start date: Nov 2025 to Aug 1, 2026
    • Study completion pushed from Nov 2027 to Nov 2028
    • Site details revised
  2. Notable Start date: Sep 2025 to Nov 2025
    • Secondary endpoints revised (5)
    • Publications: details revised at 8 of 8 entries
    v3
  3. Notable Start date: Mar 2025 to Sep 2025
    • Secondary endpoints: details revised at 3 of 5 entries
    v2
  4. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
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3,055 trials monitored
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The goal of this study is to learn how psychedelics may help symptoms of depression and anxiety. Participants with major depressive disorder experiencing symptoms of depression and anxiety will receive one dose of either a drug related to psilocybin or a placebo. Assessments include interviews, self-report questionnaires, EEG and fMRI to measure symptoms and brain function.
Trial Details
NCT Number NCT06820723
Lead Sponsor Ohio State University
Conditions
(from sponsor)
Depression, Anxiety, Major Depressive Disorder
Related terms Anxiety Disorders, Depression, Major Depressive Disorder
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov