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
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