Major Depressive Disorder, Bipolar I and Bipolar IINCT02330068
Microbiome of Depression & Treatment Response to Citalopram
An observational study of Major Depressive Disorder, Bipolar I and Bipolar II, run by Mayo Clinic at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder, Bipolar I and Bipolar II
- What is being tested?
- citalopram
- How many people
- 34 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2014to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
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).
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mayo Clinic in Florida
Jacksonville, Florida, 32224
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Microbiome of Depression &Amp; Treatment Response to Citalopram: A Feasibility Study
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.
Read the 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.
- Being tested
- citalopram
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
citalopramDrug
Also called Celexa
Cases
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: citalopram |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Over 12 weeks
Secondary outcomes (2)
Microbiome change in treatment response vs. non-response to citalopram
The gut microbiome change of patients that respond to citalopram is different
Measured: 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.
Measured: Over 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2015 (estimated)
- Study startDec 2014
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive Disorder, Bipolar I and Bipolar IIStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William V. Bobo, M.D., Mayo Clinic
- Investigators
- William Bobo, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02330068
- Sponsor's protocol ID
- 14-002154
- Status last verified
- Dec 2017
- First submitted
- 9 Dec 2014
- Last updated
- 21 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbiome of Depression &Amp; Treatment Response to Citalopram: A Feasibility Study
- ClinicalTrials.gov ID
- NCT02330068
- Acronym / sponsor ID
- 14-002154
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Dec 2014 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 1 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Drug: citalopramMale 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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).
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| citalopramAlso: CelexaCases | Drug | Cases |
Primary outcome
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
2 secondary outcomes
Microbiome change in treatment response vs. non-response to citalopram
Time frame: Over 12 weeks
Inflammatory markers of depression and their relationship to the microbiome
Time frame: Over 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Bobo, MD principal investigator
Mayo Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depressive Disorder, Bipolar I and Bipolar II, run by Mayo Clinic at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The potential differences in the microbiome between depressed patients and healthy controls (time frame: Over 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2018.