Psilocybin and Depression
Brief Summary
The main aim of the study is to investigate the possible long-term therapeutic effects of psilocybin on the symptoms of severe depression, as well as the brain mechanisms underlying these changes. Depression severity is assessed before and after (i.e., 1 week, 3 months and 6 months after) a single dose of psilocybin and compared to respective scores of a group receiving an active placebo, ketamine. Brain activity (using functional magnetic resonance imaging) is measured before and one week after drug administration in order to determine whether changes in brain networks related to emotional and self-referential processing correlate with any observed changes in depression scores. Further, blood samples will be obtained from the participants and analyzed in order to reveal gene expression and molecular level correlates underlying rapid antidepressant effects, and to identify biomarkers that predict treatment outcome.
Condition or Disease
- Severe Depression
Phase
Study Design
Study type: | Interventional |
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Status: | Unknown status |
Study results: | No Results Available |
Age: | 18 Years to 64 Years (Adult) |
Enrollment: | 60 () |
Funded by: | Other |
Masking |
Clinical Trial Dates
Start date: | Sep 01, 2018 | |
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Primary Completion: | Jan 01, 2020 | |
Completion Date: | Sep 01, 2021 | |
Study First Posted: | Dec 21, 2017 | |
Results First Posted: | Aug 31, 2020 | |
Last Updated: | Dec 21, 2017 |
Sponsors / Collaborators
Lead Sponsor:
N/A
Responsible Party:
N/A
Eligibility Criteria
Sex: | All |
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Minimum Age: | 18 |
Maximum Age: | 64 |
More Details
NCT Number: | NCT03380442 |
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Acronym: | Psilo101 |
Other IDs: | 2016-004195-22 |
Study URL: | https://ClinicalTrials.gov/show/NCT03380442 |
Last updated: Jun 16, 2022