Neurobiological Effects of Psilocybin in Treatment Resistant Bipolar Depression (Psilo-BD)

This open-label, single-arm trial (n=30) aims to evaluate the neurobiological effects of a single dose of psilocybin (25mg) in individuals with treatment-resistant bipolar depression (TRBD).

The study, sponsored by the University Health Network in Toronto and led by Dr Joshua Rosenblat, will utilise functional magnetic resonance imaging (fMRI) to assess changes in amygdala activity following psilocybin administration. Participants will undergo preparatory, monitoring, and integration psychotherapy sessions alongside the psilocybin dose.

The primary objective is to investigate whether increased right amygdala activity one day after treatment correlates with improved antidepressant effects as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) over the subsequent week.

This study is set to commence in August 2024 and will be completed by January 2027.

Topic Depression Treatment-Resistant Depression Bipolar Disorder
Compound Psilocybin
Country Canada
Visit trial
Status Not yet recruiting
Results Published No
Start date 01 August 2024
End date 01 January 2027
Phase Phase I
Design Open
Type Interventional
Generation First
Participants 30
Sex All
Age 18- 65
Therapy Yes

Trial Details

This study is an open-label, single-arm, proof-of-concept study, wherein treatment resistant bipolar depression (TRBD) participants will receive one 25 mg dose of oral psilocybin accompanied by preparatory, monitoring, and integration psychotherapy sessions (psilocybin-assisted psychotherapy, or PAP). Using fMRI (functional magnetic resonance imaging), the findings of this study will provide data on the neurobiological mechanism of psilocybin in TRBD. The primary objective is to understand the dynamic role of amygdala activity by evaluating the neurobiological effects of a single psychedelic dose (25 mg) of oral psilocybin in individuals with a moderate to severe major depressive episode and a primary diagnosis of Bipolar II Disorder, with 2 or more failed treatment trials (i.e., treatment resistant bipolar depression [TRBD]). Neurobiological effects will be determined by evaluating the association between post-treatment right amygdala activity during the facial affect task (determined by fMRI one day after the psilocybin dose) and antidepressant effects (determined by changes in the Montgomery-Åsberg Depression Rating Scale [MADRS] scores over time, during the one-week period post-psilocybin dose). This is a single-arm, open-label clinical trial wherein all participants will receive the same study intervention. Hypothesis: Increased right amygdala activity on fMRI with emotional stimuli one day after psilocybin treatment will be associated with greater antidepressant effects in the one-week period post-treatment in individuals with TRBD.

NCT Number NCT06506019

Sponsors & Collaborators

University Health Network Toronto
University Health Network is a public research and teaching hospital network in Toronto. The Nikean Psychedelic Psychotherapy Research Centre was established in 2021.

Data attribution

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