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A Randomized Neuroimaging Trial of Psilocybin in Depression

Study acronym: EMBRACE
StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Primary completion date: Jun 2027 to May 2028v6 Show 4 more changesShow less
    • Start date: Mar 25, 2025 to May 28, 2025
    • Primary endpoints revised (2)
    • Study completion date: Jun 2028 to May 2029
    • Eligibility criteria shortened, about 9 words
  2. Primary completion date: Mar 2027 to Jun 2027
    • Study completion date: Mar 2028 to Jun 2028
    • Secondary endpoints: 27 to 23
    • Site contact updated
    v5
  3. Trial status: Not Yet Recruiting to Recruitingv4 Show 4 more changesShow less
    • Start date changed from estimate of Aug 2024 to Mar 25, 2025
    • Primary completion date: Aug 2027 to Mar 2027
    • Study completion date: Nov 2027 to Mar 2028
    • Site details revised
  4. Eligibility criteria expanded, about 17 wordsv3
  5. Primary completion date: Dec 2026 to Aug 2027v2 Show 5 more changesShow less
    • Start date: Dec 2023 to Aug 2024
    • Primary endpoints revised (2)
    • Study completion date: Mar 2027 to Nov 2027
    • Interventions: Niacin (Drug), Psilocybin (Drug) to Microcrystalline cellulose (Other), Psilocybin (Drug), Supportive psychotherapy (Behavioral)
    • Secondary endpoints: 25 to 27
  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The goal of this neuroimaging clinical trial is to test whether psilocybin produces significant immediate changes in functional brain activity in networks associated with mood regulation and depression compared to placebo in patients with depression. The trial aims to determine if psilocybin: 1. Changes connectivity within brain networks associated with mood and depression 2. Changes blood flow in brain regions associated with mood and depression Participants will be attend two treatment sessions where they receive an oral medication and supportive psychotherapy. At each session, participants will undergo an MRI scan after drug administration but prior to psychotherapy. Participants will be randomly to assigned to one of two groups that will receive, 1) microcrystalline cellulose (25mg) at the first visit and psilocybin (25mg) at the second visit, or 2) psilocybin (25mg) at both visits, respectively. Differences between groups will be compared to understand what effects on brain activity are specific to psilocybin.
Trial Details
NCT Number NCT06072898
Lead Sponsor Sunnybrook Health Sciences Centre
Conditions
(from sponsor)		 Depressive Disorder, Major Depressive Disorder
Related terms Depression, Depressive Disorder, Major Depressive Disorder
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov