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Major Depressive EpisodeNCT03487926

Microglial Activation in Inflammatory Bowel Disease

An observational study of Major Depressive Episode and Inflammatory Bowel Diseases, run by Centre for Addiction and Mental Health at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 of acquiring major depressive episodes (MDE). Read more about this study

Who is it for?
Ages 19 to 65 yearsHealthy volunteers can take part
What is being tested?
[18F]FEPPA
Type of treatment
Surgery or procedure
How many people
40 participants
Where
1 siteCanada
Study dates
14 Sep 2022to 19 Nov 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Community and tertiary care clinic

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 15Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Centre for Addiction and Mental Health

    Toronto, Ontario, M5T 1R8

Other trials in Canada

About this study

Official title: Naturalistic Monitoring of Microglial Activation in Inflammatory Bowel Disease

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 of acquiring major depressive episodes (MDE). Patients with both IBD and MDE will be subsequently approached to participate in the study.

Read the 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 hypothesis is that :

  1. The neuroinflammation (TSPO VT) will be increased in PFC, ACC, and insula regions in those with inflammatory bowel disease (IBD) patients compared to healthy people.
  2. The neuroinflammation (TSPO VT) in PFC, ACC, and insula regions will be reduced after treatment for IBD.

The Secondary Hypothesis:

  1. Elevations in neuroinflammation (TSPO VT) will be similar in those with ulcerative colitis and Crohn's disease.
  2. Neuroinflammation (TSPO VT) will be greater in IBD with depression than in depression without IBD.
  3. Biologics (TNFalpha antibody treatments), and fecal transplantation will be associated with greater reduction in neuroinflammation in brain than Sulfasalazine/5-Aminosalicylates.
  4. MAO-B VT will be elevated in in the PFC, ACC, and insula in IBD compared to healthy controls.

There will be no alterations to standard care of patients due to participation in the study.

Being tested
[18F]FEPPA
Medical subject headings
Inflammatory Bowel Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • [18F]FEPPARadiation

    up to 3 PET Scans ([18F]FEPPA PET scans done 3 to 6 months apart, and one [11C]SL2511.88 PET scan) and 1 MRI

Study groups in NCT03487926
Study groupRoleWhat they receive
Group 1 (IBD primary diagnosis)Participants have active IBD
Receives: Radiation: [18F]FEPPA
Group 2( IBD + comorbid MDE)1 [18F]FEPPA PET scan in those with IBD symptoms in the past 2 years as well present with MDE
Receives: Radiation: [18F]FEPPA
Group 3-ControlsMatched for Level of Depressive Symptoms and Otherwise Healthy -Subjects in an otherwise healthy state with major depressive episodes, obsessive compulsive disorder, or generalized anxiety disorder will provide psychiatric diagnosis matched controls to those with IBD. Data for group three will be largely obtained from previous recent studies (it is anticipated that 95% of this data is already available).
Receives: Radiation: [18F]FEPPA

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. TSPO VT in prefrontal cortex, anterior cingulate cortex, and insula

    Between group comparison for 3 regions in IBD compared to controls (analysis done concurrently for group effect across 3 regions)

    Measured: within 3 to 4 weeks after initiation of screening

  2. change in TSPO VT in prefrontal cortex, anterior cingulate cortex, and insula before and after 3 to 6 months

    Change in TSPO VT for three regions (same units for each region)

    Measured: 3 to 6 months

  3. MAO-B VT in prefrontal cortex, anterior cingulate cortex, insula in IBD compared to controls

    Between group comparison for 3 regions in IBD compared to controls

    Measured: within 3 to 4 weeks after initiation of screening

Secondary outcomes (3)

  1. TSPO VT in prefrontal cortex, anterior cingulate cortex, insula compared between Crohns disease and ulcerative colitis

    comparison of TSPO VT in 3 regions between two types of inflammatory bowel disease

    Measured: within 3 to 4 weeks of initiating screening of subjects

  2. TSPO VT in prefrontal cortex, anterior cingulate cortex, insula compared between IBD with MDE compared to MDE controls

    Between group comparison for 3 regions in IBD compared to controls

    Measured: within 3 to 4 weeks after initiation of screening

  3. change in TSPO VT in prefrontal cortex, anterior cingulate cortex, insula compared between naturalistic treatment with sulfasalazine/5-aminosalicylates versus other interventions like biologics or fecal transplantation

    differential change in TSPO VT across 3 regions before and after 6 months in those receiving naturalistic treatment with sulfasalazine/5-aminosalicylates versus other naturalistic treatments of fecal transplantation or biologics

    Measured: 3 to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2018
  2. Study start14 Sep 2022
  3. Primary completion19 Nov 2024
  4. Study completion19 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03487926
Sponsor's protocol ID
102-2016
Status last verified
Apr 2025
First submitted
18 Jan 2018
Last updated
22 Apr 2025
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Setiawan E, Wilson AA, Mizrahi R, Rusjan PM, Miler L, Rajkowska G, Suridjan I, Kennedy JL, Rekkas PV, Houle S, Meyer JH. Role of translocator protein density, a marker of neuroinflammation, in the brain during major depressive episodes. JAMA Psychiatry. 2015 Mar;72(3):268-75. doi: 10.1001/jamapsychiatry.2014.2427.

    PubMed 25629589

  • Attwells S, Setiawan E, Wilson AA, Rusjan PM, Mizrahi R, Miler L, Xu C, Richter MA, Kahn A, Kish SJ, Houle S, Ravindran L, Meyer JH. Inflammation in the Neurocircuitry of Obsessive-Compulsive Disorder. JAMA Psychiatry. 2017 Aug 1;74(8):833-840. doi: 10.1001/jamapsychiatry.2017.1567.

    PubMed 28636705

  • Holmes SE, Hinz R, Conen S, Gregory CJ, Matthews JC, Anton-Rodriguez JM, Gerhard A, Talbot PS. Elevated Translocator Protein in Anterior Cingulate in Major Depression and a Role for Inflammation in Suicidal Thinking: A Positron Emission Tomography Study. Biol Psychiatry. 2018 Jan 1;83(1):61-69. doi: 10.1016/j.biopsych.2017.08.005. Epub 2017 Aug 12.

    PubMed 28939116

  • Li H, Sagar AP, Keri S. Translocator protein (18kDa TSPO) binding, a marker of microglia, is reduced in major depression during cognitive-behavioral therapy. Prog Neuropsychopharmacol Biol Psychiatry. 2018 Apr 20;83:1-7. doi: 10.1016/j.pnpbp.2017.12.011. Epub 2017 Dec 19.

    PubMed 29269262

Questions about this trial

What is this clinical trial studying?

An observational study of Major Depressive Episode and Inflammatory Bowel Diseases, run by Centre for Addiction and Mental Health at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

TSPO VT in prefrontal cortex, anterior cingulate cortex, and insula (time frame: within 3 to 4 weeks after initiation of screening). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03487926, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2025.

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