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Unknown statusPhase 2

Psilocybin and Depression

NCT03380442 · Psilo101 · University of Helsinki

Closed to entry
Status
Not accepting participants
Phase 2
Phase
60
Target enrolment
—
Study sites

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • The 16-Item Quick Inventory of Depressive Symptomatology (QIDS)

    Measured over 6 months

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 64 Years
Ages
All
Sex
Not accepted
Healthy volunteers
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.

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT03380442 on ClinicalTrials.gov →

Last updated in the registry 2017-12-21. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits