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Effects of Probiotics on Symptoms of Depression (EPSD)

This study is not yet open for participant recruitment.
Verified September 2017 by Dr. Roumen Milev, Queen's University
Sponsor:
ClinicalTrials.gov Identifier:
NCT03277586
First Posted: September 11, 2017
Last Update Posted: September 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr. Roumen Milev, Queen's University
  Purpose
Preclinical and clinical studies have shown that consuming probiotics can improve mood, anxiety, and cognition, as well as alter brain activity in both rodents and healthy humans. Data from our recent open-label, 8-week pilot study provided the first evidence of these effects in depressed patients, with significant improvements observed in overall mood, anhedonia, and sleep quality. To further support this evidence and expand upon the search for biomarkers in depression, data from this pilot study is being used to plan a 16-week, double-blind randomized placebo-controlled trial to assess the effects of probiotics on depression. Participants diagnosed with depression recruited from the greater Kingston area will orally consume a probiotic supplement containing Lactobacillus helveticus and Bifidobacterium longum (Probio'Stick, Lallemand Health Solutions) or placebo once daily. Participants will undergo clinical assessments measuring mood, anxiety, cognition, and sleep using a battery of validated clinical scales to assess efficacy of the probiotic alleviating depressive symptoms; sleep will also be assessed objectively with an ambulatory polysomnogram. Neuroimaging data will be collected using magnetic resonance imaging and electroencephalography to look at functional, structural, and electrical changes in the brain associated with consumption of the probiotic. Molecular data will be collected from blood, stool, and urine samples to look at levels of cytokines and serotonin, and explore potential genes and proteins that may predict outcomes in depression. An informatics-based approach will be used to integrate clinical, neuroimaging, and molecular data to look for biomarkers that indicate disease state and predict antidepressant-like response to the probiotic. Results: We expect results to replicate and expand on our pilot data, demonstrating that probiotics are effective in alleviating symptoms of depression, and to find biomarkers that will predict these outcomes. The findings from this study will contribute robust scientific data that is currently lacking in this emerging field.

Condition Intervention Phase
Depression Anxiety Drug: Probio'Stick Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
16-week Double-blind randomized placebo-controlled dual-phase trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Probiotics on Symptoms of Depression

Resource links provided by NLM:


Further study details as provided by Dr. Roumen Milev, Queen's University:

Primary Outcome Measures:
  • Mood [ Time Frame: 16 weeks ]
    Montgomery-Asberg Depression Rating Scale


Secondary Outcome Measures:
  • Anxiety [ Time Frame: 16 weeks ]
    Generalized Anxiety Disorder 7-item Scale

  • Anhedonia [ Time Frame: 16 weeks ]
    Snaith Hamilton Pleasure Scale

  • Cognition [ Time Frame: 16 weeks ]
    CNS Vital Signs

  • Cytokines [ Time Frame: 16 weeks ]
    Blood plasma

  • Serotonin [ Time Frame: 16 weeks ]
    Blood Plasma

  • Microbiome [ Time Frame: 16 weeks ]
    Stool

  • Brain structure/function [ Time Frame: 8 weeks ]
    fMRI


Estimated Enrollment: 108
Anticipated Study Start Date: October 1, 2017
Estimated Study Completion Date: August 30, 2019
Estimated Primary Completion Date: August 30, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Probio'Stick Drug: Probio'Stick
Probiotic supplement containing Lactobacillus helveticus and Bifidobacterium longum
Placebo Comparator: Placebo Drug: Placebo
Identically formulated and packaged inactive substance

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosis of Major Depressive Disorder (MDD) according to DSM-5 as determined by MINI
  2. Current depressive episode with a MADRS score of 20
  3. Males and females between ages 18 and 65
  4. Able to understand and comply with the requirements of the study
  5. Provision of written informed consent

Exclusion Criteria:

  1. Current use of any antidepressant drug
  2. Three or more previous episodes of depression
  3. Failure to respond to another treatment in the current episode
  4. Use of any antibiotic drug in the past 4 weeks (may be eligible to participate after a 1-month washout period). Should a participant require an antibiotic drug during the 16 week study period, they may continue with the study but must take the probiotic 4-6 hours before or after they take the antibiotic.
  5. Use of any sleep medication in the past 4 weeks (may be eligible to participate after a 1-month washout period)
  6. Milk, yeast, or soy allergy
  7. History of alcohol or substance dependence in the past 6 months
  8. Use of probiotic product in the past 2 weeks (may be eligible to participate after a 2-week washout period) and during the trial
  9. Use of any type of laxative
  10. Consumption of products fortified in probiotics 2 weeks before and during the trial
  11. High risk of suicide (score 4 or more on item 10 of MADRS)
  12. Psychotic symptoms determined by the MINI
  13. Bipolar Disorder determined by the MINI
  14. Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial (determined by a pregnancy test performed at the screening visit and confirmation of the use of appropriate contraception)
  15. Immunodeficiency (immuno-compromised and immuno-suppressed participants; e.g. AIDS, lymphoma, participants undergoing long-term corticosteroid treatment, chemotherapy and allograft participants)
  16. Unstable or severe medical conditions (e.g. cancer, cardiovascular, renal, lung, diabetes, psychiatric illness, bleeding disorders, etc.)
  17. The use of natural health products (NHPs; e.g. St. John's Wort, melatonin, passion flower, etc.) that affect depression or sleep is not allowed in the trial
  18. Electroconvulsive therapy (ECT) in the year prior to participation in the study
  19. Taking medication or other not-permitted treatment that cannot be safely discontinued
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03277586


Contacts
Contact: Caroline JK Wallace, BSc 613-544-4900 ext 53325 caroline.wallace@queensu.ca
Contact: Roumen Milev, MD 613-544-4900 ext 51201 roumen.milev@queensu.ca

Sponsors and Collaborators
Queen's University
  More Information

Responsible Party: Dr. Roumen Milev, Head, Department of Psychiatry, Queen's University
ClinicalTrials.gov Identifier: NCT03277586     History of Changes
Other Study ID Numbers: 6020656
First Submitted: September 1, 2017
First Posted: September 11, 2017
Last Update Posted: September 11, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders