Clinical Trial

Investigation to Understand and Optimize Psilocybin

Study acronym: OPTIMIZE
Recruiting Phase 2
View on ClinicalTrials.gov →
Summary
This study will examine the effects of a single dose of psilocybin, administered with psychological support, on symptoms of depression. It will also assess whether different post-dosing interventions, including a non-invasive technique called transcutaneous auricular Vagus Nerve Stimulation (taVNS), influence various psychological and behavioral outcomes. In addition, the study will explore objective measures of real-world social behavior and identify early behavioral responses that may be associated with long-term treatment outcomes.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2024-07-16; most recent amendment 2025-05-19.
Status change: Not Yet Recruiting → Recruiting 2025-05-19
Trial Details
NCT Number NCT06512194
Lead Sponsor Charles Raison
Collaborators: Usona Institute, Tiny Blue Dot Foundation, Steadman Philippon Research Institute, Emory University
Conditions Depression
Enrollment 141 participants
Start Date 2025-05-13
Primary Completion 2029-05 (estimated)
Study Completion 2029-05 (estimated)
Updated on ClinicalTrials.gov 2026-08-10