Major Depressive Disorder Clinical Trial
Official title:
Biomarkers of Neuroinflammation and Anti-Inflammatory Treatments in Major Depressive Disorder
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.
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.
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