Major Depressive Disorder, Bipolar I and Bipolar II Clinical Trial
Official title:
Microbiome of Depression &Amp; Treatment Response to Citalopram: A Feasibility Study
The purpose of this study is to evaluate the feasibility of developing a microbiome probe of depression and to evaluate the microbiome change in a preliminary analysis of treatment response (n=20) vs. non response (n=20) to the antidepressant citalopram. This study is a 12 week open trial that will enroll approximately 80 participants (anticipated 40 study completers with paired biomarker data) with an episode of major depression, Bipolar I or Bipolar II and 40 age- and sex-matched healthy controls.
The study will be conducted at Mayo Clinic Jacksonville Department of Psychiatry (recruit up
to 10 patients and 10 controls with paired data) and Mayo Clinic Depression Center in
Rochester (recruit up to 30 patients and 30 controls with paired data). Patients with major
depression, Bipolar Disorder I or Bipolar Disorder II confirmed by structured diagnostic
interview (SCID) and moderate symptom severity (Quick Inventory of Depressive Symptomatology
or S-C16) will be enrolled in the 12 week study. We will explore the gut microbiome (and its
genetic material) and gut-brain markers of inflammation (cortisol, cytokines) from stool
specimens and serum samples, respectively. Collections will be at baseline, week 2, and week
12 of the study. Healthy controls matched for age, sex (including menopausal status of female
subjects), and body-mass index (BMI) will have only baseline stool and serum collections.
Statistical t-tests will be used to assess baseline differences between patient and controls
in microbiome and inflammatory markers. Treatment response (50% reduction in QIDS), treatment
remission (QIDS-C16 < 6) will be analyzed with change in microbiome and inflammation markers.
Correlational analysis with multiple testing corrections will be conducted between depression
symptom severity and measures of cortisol, cytokines, and gut microbiome composition.
This study will focus on early translation of Dr. Fryer and Dr. Chia's research and will
bring the gut-brain interface to the field of individualizing treatment to patients who
struggle with depression. This project will provide insight into how gut microbiota may be
implicated in depression, how antidepressant treatments alter microbiota composition, and how
these factors impact key physiologic mediators of depression (i.e. cortisol and cytokine
levels). The public health implications of more focused drug development and treatment for
depression are substantial.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02746367 -
Bipolar Proteomic Assay Validation Study
|