Status:
COMPLETED
Microglial Activation in Inflammatory Bowel Disease
Lead Sponsor:
Centre for Addiction and Mental Health
Collaborating Sponsors:
McMaster University
Conditions:
Major Depressive Episode
Inflammatory Bowel Diseases
Eligibility:
All Genders
19-65 years
Brief Summary
The purpose of this study is to monitor microglial activation in participants with inflammatory bowel disease (IBD) and investigate the relationship that exists between these patients and their risk o...
Detailed Description
Detailed Description: Participants may undergo up to 3 PET Scans : \[18F\]FEPPA PET (for TSPO) before and 3 to 6 months later and \[11C\]SL25.1188 PET (for MAO-B) as well as 1 MRI scan. The primary ...
Eligibility Criteria
Inclusion
- Age 18 to 65
- aside from IBD groups and common comorbidities of IBD, otherwise good physical health with no current active medical conditions.
- a lifetime diagnosis of IBD verified by medical record, which can include prescription for IBD treatment
Exclusion
- no history of neurological illness, excluding migraine
- no use of glucocorticoid antagonists or lithium or medications that bind with affinity higher than 500nM to peripheral benzodiazepine receptors (or TSPO) in the previous two months
- no use of herbal remedies in the previous month that would be expected to influence neuroinflammation
- non-cigarette smoking
- no history of abuse of substances that affect mood and negative urine drug screens for substances of abuse including cotinine (urine drug screen is done at screening and on each PET scan day)
- no history of psychotic symptoms
- not pregnant based on a negative pregnancy test (for women)
- not breastfeeding (for women)
- no recent treatment with electroconvulsive therapy or magnetic seizure therapy in the previous 6 months
- no coagulation disorders, or anticoagulant medication use
- no presence of metal objects or implanted electrical devices in the body that would preclude MRI scanning
- no claustrophobia
- no self-reported history of fainting from blood withdrawals
- size and weight does not exceed capacity of scanner, for which size may vary and weight is 350 lbs
- no history of undergoing a number of PET scans that, including the number of PET scans under this protocol, will bring the total to more than 8 PET scans/lifetime, exceeding permissible limit for subjects participating in research set by our centre's guidelines
Key Trial Info
Start Date :
September 14 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 19 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03487926
Start Date
September 14 2022
End Date
November 19 2024
Last Update
April 22 2025
Active Locations (1)
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1
Centre for Addiction and Mental Health
Toronto, Ontario, Canada, M5T 1R8