Status:
UNKNOWN
Psilocybin and Depression
Lead Sponsor:
University of Helsinki
Collaborating Sponsors:
Dr. Tomi Rantamäki, Laboratory of Neurotherapeutics, Department of Biosciences, University of Helsinki
Dr. Robin Carthart-Harris and Prof. David Nutt, Imperial College London, UK
Conditions:
Severe Depression
Eligibility:
All Genders
18-64 years
Phase:
PHASE2
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. Dep...
Eligibility Criteria
Inclusion
- Major depression of a moderate to severe degree (17+ on the 21-item HAM-D).
- No health-related contraindications.
Exclusion
- Current or previously diagnosed psychotic disorder.
- Immediate family member with a diagnosed psychotic disorder.
- Medically significant condition rendering unsuitability for the study (e.g., diabetes, epilepsy, severe cardiovascular disease, hepatic or renal failure etc.).
- History of suicide attempts.
- History of mania.
- Current 5-HT2A antagonist antidepressant medication.
- Blood or needle phobia.
- Positive pregnancy test.
- Current drug or alcohol dependence.
- Lack of appropriate use of contraception.
- Breast-feeding.
Key Trial Info
Start Date :
September 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2021
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03380442
Start Date
September 1 2018
End Date
September 1 2021
Last Update
December 21 2017
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