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.
Study Type
OBSERVATIONAL
Enrollment
34
Cases
Mayo Clinic in Florida
Jacksonville, Florida, United States
Mayo Clinic in Rochester
Rochester, Minnesota, United States
The potential differences in the microbiome between depressed patients and healthy controls
The gut microbiome of depressed patients is different from that of age-, sex-, menopause-, and BMI-matched healthy controls
Time frame: Over 12 weeks
Microbiome change in treatment response vs. non-response to citalopram
The gut microbiome change of patients that respond to citalopram is different
Time frame: Over 12 weeks
Inflammatory markers of depression and their relationship to the microbiome
Changes in inflammatory markers of depression correspond to changes in depression symptom severity.
Time frame: Over 12 weeks
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