The Efficacy, Safety, and Tolerability of Probiotics on the Mood and Cognition of Depressed Patients

Last updated: June 13, 2019
Sponsor: Queen's University
Overall Status: Completed

Phase

3

Condition

Depression

Depression (Major/severe)

Affective Disorders

Treatment

N/A

Clinical Study ID

NCT02838043
6016312
  • Ages 18-65
  • All Genders

Study Summary

This study will be an 8-week open-label pilot study examining subjective and objective changes in mood, anxiety, cognition, and sleep before and after the introduction of a probiotic supplement containing Lactobacillus helveticus and Bifidobacterium longum in 10 treatment-naïve participants diagnosed with major depressive disorder (MDD). In order to examine the full composition of the micro biome, the investigators will also be collecting and analyzing fecal samples as well as blood samples to examine changes in plasma levels of inflammatory markers, 5-HT, and tryptophan in order to look at possible underlying mechanisms of any changes seen.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Diagnosis of Major Depressive Disorder (MDD) by Mini International NeuropsychiatricInterview (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

Exclusion Criteria:

  1. Use of any antidepressant drug

  2. Use of any antibiotic drug in the past 4 weeks (may be eligible to participate after a 1-month washout period)

  3. Use of any sleep medication in the past 4 weeks (may be eligible to participate aftera 1-month washout period)

  4. Milk, yeast, or soy allergy

  5. History of alcohol or substance abuse in the past 6 months

  6. Daily use of probiotic product in the past 2 weeks (may be eligible to participateafter a 2-week washout period)

  7. Use of any type of laxative

  8. Consumption of products fortified in probiotics

  9. Severely suicidal

  10. Experiencing psychosis or bipolar episode

  11. History of epilepsy or uncontrolled seizures

Study Design

Total Participants: 10
Study Start date:
August 01, 2016
Estimated Completion Date:
May 31, 2018

Connect with a study center

  • Providence Care - Mental Health Services

    Kingston, Ontario K7L 4X3
    Canada

    Site Not Available

  • Queen's University

    Kingston, Ontario K7L 3N6
    Canada

    Site Not Available

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