Actively Recruiting
Neurobiological Effects of Psilocybin in Treatment Resistant Bipolar Depression
Led by University Health Network, Toronto · Updated on 2024-10-18
30
Participants Needed
1
Research Sites
116 weeks
Total Duration
On this page
Sponsors
U
University Health Network, Toronto
Lead Sponsor
C
Centre for Addiction and Mental Health
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Neurobiological Effects of Psilocybin in Treatment Resistant Bipolar Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 to 65 years old
- Able to give informed consent
- Willing to follow all study procedures
- Able to read and understand English
- Diagnosed with Bipolar II Disorder currently in a moderate to severe major depressive episode without psychotic features
- Depression confirmed by a mood disorder specialist and the Mini-International Neuropsychiatric Interview
- Current depression with a Hamilton Depression Rating Scale score over 20 and inadequate response to two or more treatments
- Able to take oral medication
- Currently taking or planning to take lamotrigine without changes during the study
- If able to become pregnant, using highly effective contraception for at least 3 months before screening and during the study
- If able to father a child, using effective contraception during the study
- Willing to taper off current medications for at least 1 month before baseline with physician approval
- Agree to follow lifestyle considerations throughout the study
You will not qualify if you...
- Pregnant, breastfeeding, or intending to become pregnant during the study
- Treatment with another investigational drug or intervention within 30 days before screening
- Current symptoms of mania, hypomania, or mixed features with a Young Mania Rating Scale score over 12
- History of mania or hypomania in the past 6 months
- Substance use disorder (other than tobacco) in the past 12 months
- Active suicidal thoughts or recent suicide attempts
- Diagnosis of schizophrenia-spectrum or psychotic disorders, bipolar I disorder, or certain personality disorders
- Contraindications to MRI
- History of seizures
- Taking anticonvulsants other than lamotrigine or benzodiazepines above lorazepam 2 mg/day
- History of Stevens-Johnson Syndrome
- Close family history of schizophrenia-spectrum or bipolar I disorder
- Certain heart, kidney, liver, or blood pressure conditions
- Prolonged QTc or related heart rhythm issues
- Allergy or intolerance to lamotrigine or psilocybin
- Unwilling or unable to take lamotrigine as prescribed
- Use of classic psychedelics within 6 months before consent
- Use of steroids or certain supplements within 1 week before psilocybin administration
- Any other serious physical illness that could affect study results or participant safety
AI-Screening
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Trial Site Locations
Total: 1 location
1
Toronto Western Hospital - University Health Network
Toronto, Ontario, Canada, M5T 2S8
Actively Recruiting
Research Team
E
Erica Kaczmarek, HBSc
CONTACT
Z
Zoe Doyle, BScN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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