A Pilot Mechanistic Study of Psilocybin-Assisted Therapy as a Treatment for Depression
Washington University School of Medicine
Summary
Depression is the leading cause of disability worldwide, affecting an estimated 300 million people. Despite available treatments, response rates remain modest, and treatment resistance is common. Novel treatments are needed that act rapidly, produce lasting effects and work differently than existing antidepressants. In clinical trials, psilocybin has shown promise as a treatment for depression due to its rapid onset of antidepressant effects and sustained benefits. This study will use MRI scanning of the brain and other biological measures (biomarkers) to investigate how psilocybin affects brain activity and psychological flexibility before, during, and after receiving psilocybin in participants with depressive symptoms.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Age \> 18 years 2. Participants of childbearing potential must agree to practice 2 forms of effective birth control throughout the duration of the study 3. Females of childbearing potential must have a negative urine pregnancy test at Screening and prior to dosing on Dosing Day 4. Diagnosis of depression at Screening via the SCID-5-CT interview and MADRS score of ≥7 5. Have an identified support person Agree to be accompanied home (or to an otherwise safe destination) by the support person, or another responsible party, following dosing Exclusion Criteria: 1. Unable t…
Interventions
- DrugPsilocybin (Usona Institute)
Capsule containing 25 mg of synthetic psilocybin
Location
- Washington University School of MedicineSt Louis, Missouri