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Psilocybin rTMS for Treatment Resistant Depression

Study acronym: PSILOBSD
StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Eligibility criteria expanded, about 72 wordsv7
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jan 1, 2025 to Jan 10, 2025
    • Study description revised
    • Site details revised
    v6
  3. Primary completion date: Mar 15, 2028 to Dec 31, 2029
    • Start date: Sep 1, 2024 to Jan 1, 2025
    • Study completion date: May 15, 2028 to Dec 31, 2030
    v5
  4. Primary completion date: Mar 15, 2027 to Mar 15, 2028
    • Start date: Jun 1, 2024 to Sep 1, 2024
    • Study completion date: May 15, 2027 to May 15, 2028
    v4
  5. Start date: Jan 1, 2024 to Jun 1, 2024v3
  6. Secondary endpoints: 22 to 21v2
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 purpose of this study is to determine the safety and feasibility of sequencing psilocybin therapy with a short-duration, aiTBS protocol (Stanford Accelerated Intelligent Neuromodulation Therapy, or SAINT) in individuals with treatment-resistant major depressive disorder.
Trial Details
NCT Number NCT06132178
Lead Sponsor University of Texas at Austin
Conditions
(from sponsor)		 Treatment Resistant Depression, MDD, Major Depressive Disorder, Recurrent Depression, Depression
Related terms Depression, Depressive Disorder, Treatment-Resistant, Major Depressive Disorder
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov