A Randomized Neuroimaging Trial of Psilocybin in Depression

This Phase II interventional trial (n=50) sponsored by Sunnybrook Health Sciences Centre aims to investigate whether psilocybin (25mg) induces significant immediate changes in functional brain activity related to mood regulation and depression.

Participants, aged 18 to 64, diagnosed with depressive disorder, will undergo two treatment sessions involving oral medication and supportive psychotherapy, along with MRI scans. They will be randomly assigned to receive either niacin (100mg) at the first session and psilocybin (25mg) at the second, or psilocybin (25mg) at both sessions.

The trial will measure changes in regional blood flow, functional network connectivity, and depressive symptoms, among other outcomes, to understand the effects of psilocybin on depression.

Recruitment for this trial has not yet started, with an estimated study start date of December 2023 and a completion date of March 2027. For further information, contact Sean Nestor, PhD MD FRCPC at Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.

Topic Depression
Compound Psilocybin Placebo
Country Canada
Visit trial
Status Not yet recruiting
Results Published No
Start date 01 December 2023
End date 31 March 2027
Phase Phase II
Design Open
Type Interventional
Generation First
Participants 50
Sex All
Age 18- 64
Therapy Yes

Trial Details

The goal of this neuroimaging clinical trial is to test whether psilocybin produces significant immediate changes in functional brain activity in networks associated with mood regulation and depression compared to placebo in patients with depression. The trial aims to determine if psilocybin: changes connectivity within brain networks associated with mood and depression changes blood flow in brain regions associated with mood and depression Participants will be attend two treatment sessions where they receive an oral medication and supportive psychotherapy. At each session, participants will undergo an MRI scan after drug administration but prior to psychotherapy. Participants will be randomly to assigned to one of two groups that will receive, 1) niacin (100mg) at the first visit and psilocybin (25mg) at the second visit, or 2) psilocybin (25mg) at both visits, respectively. Differences between groups will be compared to understand what effects on brain activity are specific to psilocybin.

NCT Number NCT06072898

Sponsors & Collaborators

Sunnybrook Health Sciences Centre
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Data attribution

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