Microbiome of Depression & Treatment Response to Citalopram

NCT02330068 | Completed

• 1 other identifier: 14-002154
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Major Depressive Disorder, Bipolar I and Bipolar II

Outcome Measures

Primary Outcomes (1)

• 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

  Over 12 weeks

Secondary Outcomes (2)

• Microbiome change in treatment response vs. non-response to citalopram

  Over 12 weeks

• Inflammatory markers of depression and their relationship to the microbiome

  Over 12 weeks

Study Arms (2)

Controls

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.

Cases

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.

Drug: citalopram

Interventions

citalopram DRUG

Cases

Also known as: Celexa

Cases

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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).

You may qualify if:

• Outpatients or inpatients with nonpsychotic major depressive disorder (MDD) or Bipolar I or II Disorder.
• 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

You may not qualify if:

• 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
• Subjects diagnosed with Borderline Personality Disorder (BPD) as their primary diagnosis.
• 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 unless they remain on a stable dose of the medication for the 12 weeks of 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (2)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood, saliva and stool samples will be collected at three time points.

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Citalopram

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• William Bobo, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: December 9, 2014
• First Posted: January 1, 2015
• Study Start: December 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: March 21, 2018

Record last verified: 2017-12

Locations

US (2)