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.
Topic Depression
Compound Psilocybin
Placebo
Country Finland
United Kingdom
Visit trial
Status
Terminated
Results Published
No
Start date
09 January 2018
End date
09 January 2021
Chance of happening
10%
Phase
Phase II
Design
Blinded
Type
Interventional
Generation
First
Participants
60
Sex
All
Age
18- 64
Therapy
No
Trial Details
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.NCT Number NCT03380442
Sponsors & Collaborators
University of HelsinkiThe Korpi Lab at the University of Helsinki is focused on understanding the neurochemical basis of behaviour and has done so using LSD.
Imperial College London
The Centre for Psychedelic Research studies the action (in the brain) and clinical use of psychedelics, with a focus on depression.
Measures Used
Quick Inventory of Depressive SymptomatologyThe Quick Inventory of Depressive Symptomatology (Self-Report) (QIDS-SR16) is a self-report tool designed to screen for depression and measure changes in the severity of symptoms.
Montgomery-Asberg Depression Rating Scale
A ten-item diagnostic questionnaire used to measure the severity of depressive symptoms in patients with mood disorders.
Hamilton Depression Rating Scale
The Hamilton Depression Rating Scale (HDRS) is a multiple item questionnaire used to provide an indication of depression, and as a guide to evaluating recovery. The scale consists of 17 items which each item being scoring on a 3 or 5 point scale. The higher the score, the more likely a person is depressed.