Microbiome of Depression & Treatment Response to Citalopram
|ClinicalTrials.gov Identifier: NCT02330068|
Recruitment Status : Completed
First Posted : January 1, 2015
Last Update Posted : March 21, 2018
|Condition or disease||Intervention/treatment|
|Major Depressive Disorder, Bipolar I and Bipolar II||Drug: citalopram|
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|
|Actual Enrollment :||34 participants|
|Official Title:||Microbiome of Depression &Amp; Treatment Response to Citalopram: A Feasibility Study|
|Actual Study Start Date :||December 2014|
|Actual Primary Completion Date :||December 2017|
|Actual Study Completion Date :||December 2017|
Males and females ages 18-55 without Major Depressive Disorder, Bipolar I or Bipolar II who are not on an antidepressant and do not have a first degree relative with a diagnosis of Major Depressive Disorder and not currently taking citalopram.
Male or female participants ages 18-55 with Major Depressive Disorder, Bipolar I or Bipolar II whom antidepressant treatment is deemed necessary will be given citalopram.
Other Name: Celexa
- The potential differences in the microbiome between depressed patients and healthy controls [ Time Frame: Over 12 weeks ]The gut microbiome of depressed patients is different from that of age-, sex-, menopause-, and BMI-matched healthy controls
- Microbiome change in treatment response vs. non-response to citalopram [ Time Frame: Over 12 weeks ]The gut microbiome change of patients that respond to citalopram is different
- Inflammatory markers of depression and their relationship to the microbiome [ Time Frame: Over 12 weeks ]Changes in inflammatory markers of depression correspond to changes in depression symptom severity.
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02330068
|United States, Florida|
|Mayo Clinic in Florida|
|Jacksonville, Florida, United States, 32224|
|United States, Minnesota|
|Mayo Clinic in Rochester|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||William Bobo, MD||Mayo Clinic|