Microbiome of Depression & Treatment Response to Citalopram
Information source: Mayo Clinic
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Major Depressive Disorder
Intervention: citalopram (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Mayo Clinic Official(s) and/or principal investigator(s): Mark Frye, MD, Principal Investigator, Affiliation: Mayo Clinic
Overall contact: Deanna Hofschulte, Phone: 507-255-2972, Email: hofschulte.deanna@mayo.edu
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 and 40 age- and
sex-matched healthy controls.
Clinical Details
Official title: Microbiome of Depression &Amp; Treatment Response to Citalopram: A Feasibility Study
Study design: Observational Model: Case Control, Time Perspective: Prospective
Primary outcome: The potential differences in the microbiome between depressed patients and healthy controls
Secondary outcome: Microbiome change in treatment response vs. non-response to citalopramInflammatory markers of depression and their relationship to the microbiome
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 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Outpatients or inpatients with nonpsychotic major depressive disorder (MDD).
- A score of >16 on the QIDS
- Outpatients or inpatients for whom antidepressant treatment is deemed appropriate by
the treating clinician
- Subjects who are between 18-55 years of age
Exclusion Criteria:
- Contraindications to citalopram treatment
- Axis I or II disorder other than depression that is the primary reason for seeking
treatment intervention and/or psychiatric care
- For healthy controls, a first degree relative who has been diagnosed with an Axis I
disorder
- Patients with schizophrenia, schizoaffective disorder, or bipolar I disorder
- Antidepressant treatment within 4 days of study (1 week if fluoxetine). Subjects
currently on antidepressant medication with subtherapeutic results in terms of
depression management after providing informed consent, will undergo a medication
taper and discontinuation prior to initiation of citalopram treatment. The subject
must be off of previous antidepressants for at least 4 days week prior to starting
citalopram (1 week if fluoxetine). The subject will be closely monitored by the
research study psychiatrist (with or without additional monitoring from primary
clinical psychiatric providers). The medication taper is left up to the research
study psychiatrist in consultation with patient's primary care or psychiatric
provider. Study subjects who cannot be safely tapered from their medication or
experience adverse effects during the taper will be excluded from the study
- Study subjects using their antidepressant medication for management of nicotine
dependence, chronic pain, migraine prophylaxis, or other diagnoses will not be
eligible for the study
- Subjects currently on antipsychotic medications (i. e., typical or atypical
antipsychotic drugs) and mood stabilizing(e. g., lithium, carbamazepine, valproate,
lamotrigine, gabapentin, or other anticonvulsants) are not eligible for the study.
Trazodone, melatonin, and diphenhydramine may be used as rescue medications for
insomnia. Benzodiazepines may be used for treatment of anxiety, not to exceed 4 mg/24
hour of lorazepam
- Subjects who are currently on an antibiotic or an antibiotic within 2 weeks. (Topical
antibiotics are OK)
- Daily use of aspirin, NSAID's or Warfarin (low dose of baby aspirin OK)
- Subjects unable to give informed consent are excluded
- Pregnant subjects will be excluded
- Subjects who are currently breastfeeding and who plan to continue breastfeeding will
be excluded
- Postmenopausal women are not eligible for this study
Locations and Contacts
Deanna Hofschulte, Phone: 507-255-2972, Email: hofschulte.deanna@mayo.edu
Mayo Clinic in Florida, Jacksonville, Florida 32224, United States; Recruiting
Mayo Clinic in Rochester, Rochester, Minnesota 55905, United States; Recruiting
Additional Information
Starting date: December 2014
Last updated: May 14, 2015
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