NCT02362529

Biomarkers of Neuroinflammation and Anti-Inflammatory Treatments in Major Depressive Disorder

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 115 (estimated)
• Sponsor: Centre for Addiction and Mental Health · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine if translocator protein total distribution volume (TSPO VT) is elevated in major depressive disorder that is not responding to medication and if adding minocycline can affect TSPO VT. Many remain treatment resistant with common antidepressant treatments and the investigators think it may be due to poor targeting of brain pathologies.

Detailed description

There will be three Phases in the study. Only MDE subjects will be invited to continue to Phase 2 and 3. Subjects will be invited to continue to the subsequent Phase given they meet entry criteria described below: Phase 1: The investigators will evaluate whether TSPO is elevated in individuals during a current MDE compared to healthy controls. Eligible participants will receive one \[18F\]FEPPA PET scan and one MRI scan. Other measures will include urine sample, blood samples for genetic and peripheral biomarker analysis, a neurocognitive battery, mood scales and questionnaires. Phase 2: Participants who have elevated TSPO VT in Phase 1 and are agreeable to receiving minocycline will be invited to participate in Phase 2. Based on our previous results participants will be considered candidates for Phase 2 if TSPO VT ≥ 10.5 (HAB) or ≥8.5 (MAB) in any of the primary regions of interest (prefrontal cortex, anterior cingulate cortex or insula). Eligible participants will be invited to participate in a randomized, double blind, placebo controlled trial, to receive either minocycline or placebo. After the eight weeks of treatment, participants will receive one \[18F\]FEPPA PET scan. Other measures will include urine samples, blood samples, mood scales and questionnaires. Phase 3: If, after the initial eight week treatment period with either minocycline or placebo, any participant continues to have depressive symptoms (17-item Hamilton Depression Rating Scale score ≥ 8) they will be invited to participate in an eight week open label trial of celecoxib. Participants not eligible for Phase 2 may also be invited to participate in Phase 3 directly from Phase 1.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	Minocycline	50 mg and 100 mg capsule, oral administration
DRUG	Placebo	Lactose monohydrate in identical gel capsules to minocycline, oral administration.
DRUG	Celecoxib	100 mg and 200 mg capsules, oral administration.

Timeline

• Start date: 2015-02-01
• Primary completion: 2019-04-01
• Completion: 2019-04-01
• First posted: 2015-02-13
• Last updated: 2019-05-23

Locations

1 site across 1 country: Canada