Microbiome of Depression & Treatment Response to Citalopram
Condition: Major Depressive Disorder, Bipolar I and Bipolar II
MeSH terms: Depressive Disorder; Depressive Disorder, Major; Bipolar Disorder
Study type: Observational

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): citalopram
Intervention type(s): Drug
Intervention description(s): Cases
Other intervention name(s): Celexa
Intervention MeSH terms: Citalopram
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The investigators will enroll 80 participants, both male and female with the goal of having
        20 paired data of responders and 20 non-responders each. Forty age-matched healthy controls
        will also be recruited. The investigators will recruit 100 subjects anticipating drop outs
        or inability to participate fully with microbiome sample collection and /or at least paired
        biological specimens before and after treatment. The Mayo Clinic Jacksonville patients
        (n=10) will be matched with Mayo Clinic Jacksonville controls (n=10) and the Mayo Clinic
        Rochester patients (n=30) will be matched with the Mayo Clinic Rochester controls (n=30).
      
Biospecimen description: 
      Blood, saliva and stool samples will be collected at three time points.