PET Synaptogenesis After Psilocybin In DEpression Recovery (PET-SPIDER)

This neuroimaging trial (n=24) investigates the effects of one high dose of psilocybin (25mg) in those with depression. It specifically investigates the synaptic density (synapses are the connections between brain cells; neurons). The aim is to assess the relationship between the antidepressant and neurotrophic (growth within brain) effects of psilocybin.

Status Not yet recruiting
Results Published No
Start date 01 January 2023
End date 01 January 2025
Chance of happening 100%
Phase Phase II
Design Open
Type Interventional
Generation First
Participants 24
Sex All
Age 18- 65
Therapy No

Trial Details

Participants with depression will be given a single dose of psilocybin and supportive psychotherapy before, during, and after drug administration. Participants will undergo positron emission tomography (PET) imaging before and one week after psilocybin using a marker of synaptic density. This design allows us to assess the relationship between neurotrophic, and antidepressant effects produced by psilocybin. The investigators are studying the neurotrophic effects of psilocybin using 11C-UCB-J, a PET marker for synaptogenesis. Psilocybin is a naturally occurring psychedelic and exerts perceptual effects via 5-HT2A receptor agonism. Psilocybin has gained a great deal of attention as a tool for psychiatric treatment, with clinical trials demonstrating symptom relief after a single dose that is immediate and persists for months. Recognizing the therapeutic potential of psilocybin, the US Food and Drug Administration granted breakthrough therapy status to the Usona Institute for Phase 2 testing of psilocybin in depression. Animal models suggest that psychedelics exert antidepressant effects by producing a rapid and powerful neurotrophic response in the brain. The investigators will enroll patients with major depressive disorder and anhedonia. Participants will be given a single dose of psilocybin and supportive psychotherapy before, during, and after drug administration. Participants will undergo PET imaging before and one week after drug using 11C-UCB-J, a radiotracer that binds to SV2A - a marker of synaptic density and synaptogenesis. This design allows the investigators to assess the relationship between neurotrophic, and antidepressant effects produced by psilocybin.

NCT Number NCT05601648

Sponsors & Collaborators

Washington University School of Medicine
Located in St. Louis Missouri, researchers at the Washington University School of Medicine have conducted a number of studies with psychedelics inlcuding ketamine, psilocybin and nitrous oxide.

Measures Used

Montgomery-Asberg Depression Rating Scale
A ten-item diagnostic questionnaire used to measure the severity of depressive symptoms in patients with mood disorders.

Data attribution

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