Psilocybin and Depression

• Status: Unknown status
• Trial end date: 2021-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Helsinki
• Collaborators: Dr. Robin Carthart-Harris and Prof. David Nutt, Imperial College London, UK; Dr. Tomi Rantamäki, Laboratory of Neurotherapeutics, Department of Biosciences, University of Helsinki
• Treatments: Ketamine; Psilocybin

Criteria

Inclusion Criteria:

1. Major depression of a moderate to severe degree (17+ on the 21-item HAM-D).

2. No health-related contraindications.

Exclusion Criteria:

1. Current or previously diagnosed psychotic disorder.

2. Immediate family member with a diagnosed psychotic disorder.

3. Medically significant condition rendering unsuitability for the study (e.g., diabetes, epilepsy, severe cardiovascular disease, hepatic or renal failure etc.).

4. History of suicide attempts.

5. History of mania.

6. Current 5-HT2A antagonist antidepressant medication.

7. Blood or needle phobia.

8. Positive pregnancy test.

9. Current drug or alcohol dependence.

10. Lack of appropriate use of contraception.

11. Breast-feeding.