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

Primary Purpose

Major Depressive Disorder, Depression, Depressive Symptoms

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Probio'Stick
Sponsored by
Queen's University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Diagnosis of Major Depressive Disorder (MDD) by Mini International Neuropsychiatric Interview (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. 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 after a 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 participate after 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

Sites / Locations

  • Queen's University
  • Providence Care - Mental Health Services

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Participant

Arm Description

All participants will be experimental and receive Probio'Stick.

Outcomes

Primary Outcome Measures

Mood
Mood will be assessed with the Montgomery-Asberg Depression Rating Scale (MADRS) with a cut-off score of 12 indicating remission.

Secondary Outcome Measures

Anxiety
Anxiety will be assessed with the Generalized Anxiety Disorder Scale (GAD-7).
Cognition
Cognition will be assess with the Digit Symbol Substitution Test (DSST).
Sleep
Sleep will be assessed objectively using a polysomnogram to look at changes electrophysiological sleep architecture after 8 weeks of treatment.
Plasma
Plasma will be analyzed to look at levels of inflammatory markers to see whether there is a decrease after 8 weeks of treatment.

Full Information

First Posted
June 2, 2016
Last Updated
June 13, 2019
Sponsor
Queen's University
Collaborators
Lallemand Health Solutions, McMaster University
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1. Study Identification

Unique Protocol Identification Number
NCT02838043
Brief Title
The Efficacy, Safety, and Tolerability of Probiotics on the Mood and Cognition of Depressed Patients
Official Title
The Efficacy, Safety, and Tolerability of Probiotics on the Mood and Cognition of Depressed Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
August 2016 (undefined)
Primary Completion Date
May 2018 (Actual)
Study Completion Date
May 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen's University
Collaborators
Lallemand Health Solutions, McMaster University

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder, Depression, Depressive Symptoms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Participant
Arm Type
Experimental
Arm Description
All participants will be experimental and receive Probio'Stick.
Intervention Type
Dietary Supplement
Intervention Name(s)
Probio'Stick
Intervention Description
A combination of the probiotic strains Lactobacillus helveticus and Bifidobacterium longum
Primary Outcome Measure Information:
Title
Mood
Description
Mood will be assessed with the Montgomery-Asberg Depression Rating Scale (MADRS) with a cut-off score of 12 indicating remission.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Anxiety
Description
Anxiety will be assessed with the Generalized Anxiety Disorder Scale (GAD-7).
Time Frame
8 weeks
Title
Cognition
Description
Cognition will be assess with the Digit Symbol Substitution Test (DSST).
Time Frame
8 weeks
Title
Sleep
Description
Sleep will be assessed objectively using a polysomnogram to look at changes electrophysiological sleep architecture after 8 weeks of treatment.
Time Frame
8 weeks
Title
Plasma
Description
Plasma will be analyzed to look at levels of inflammatory markers to see whether there is a decrease after 8 weeks of treatment.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of Major Depressive Disorder (MDD) by Mini International Neuropsychiatric Interview (MINI) Current depressive episode with a MADRS score of ≥ 20 Males and females between ages 18 and 65 Able to understand and comply with the requirements of the study Provision of written informed consent Exclusion Criteria: Use of any antidepressant drug Use of any antibiotic drug in the past 4 weeks (may be eligible to participate after a 1-month washout period) Use of any sleep medication in the past 4 weeks (may be eligible to participate after a 1-month washout period) Milk, yeast, or soy allergy History of alcohol or substance abuse in the past 6 months Daily use of probiotic product in the past 2 weeks (may be eligible to participate after a 2-week washout period) Use of any type of laxative Consumption of products fortified in probiotics Severely suicidal Experiencing psychosis or bipolar episode History of epilepsy or uncontrolled seizures
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roumen Milev, PhD, MD
Organizational Affiliation
Queen's University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen's University
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 3N6
Country
Canada
Facility Name
Providence Care - Mental Health Services
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 4X3
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data will not be shared.

Learn more about this trial

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

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