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.

Intervention / Treatment

  • Drug: Psilocybin
  • Drug: Ketamine (Ketalar)

Condition or Disease

  • Severe Depression

Phase

Study Design

Study type: Interventional
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
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
Minimum Age: 18
Maximum Age: 64

More Details

NCT Number: NCT03380442
Acronym: Psilo101
Other IDs: 2016-004195-22
Study URL: https://ClinicalTrials.gov/show/NCT03380442
Last updated: Jun 16, 2022