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Active, not recruiting Phase 3 Interventional

Psilocybin for Major Depressive Disorder (MDD)

NCT06308653
Conditions
Depressive Disorder, Major
Interventions
Psilocybin 25 mg, Inactive Placebo, Psilocybin 5 mg, Psychosocial Support
Drug · Behavioral
Lead sponsor
Usona Institute
Other
Eligibility
18 Years and older
Enrollment
238 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2027
U.S. locations
29
States / cities
Birmingham, Alabama • Fayetteville, Arkansas • Little Rock, Arkansas + 25 more
Conditions
Post Traumatic Stress Disorder, Depression - Major Depressive Disorder
Interventions
Psilocybin + MBCT therapy, Active Comparator: Psilocybin with Support Only
Combination Product
Lead sponsor
Anthony P King
Other
Eligibility
21 Years to 65 Years
Enrollment
30 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2029
U.S. locations
1
States / cities
Columbus, Ohio