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Effects of Probiotics on Symptoms of Depression (EPSD)

Primary Purpose

Depression, Anxiety

Status

Terminated

Phase

Phase 3

Locations

Canada

Study Type

Interventional

Intervention

Probio'Stick

Placebo

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

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

Inclusion Criteria:

Diagnosis of Major Depressive Disorder (MDD) according to DSM-5 as determined by 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:

Current use of any antidepressant drug
Three or more previous episodes of depression
Failure to respond to another treatment in the current episode
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.
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 dependence in the past 6 months
Use of probiotic product in the past 2 weeks (may be eligible to participate after a 2-week washout period) and during the trial
Use of any type of laxative
Consumption of products fortified in probiotics 2 weeks before and during the trial
High risk of suicide (score 4 or more on item 10 of MADRS)
Psychotic symptoms determined by the MINI
Bipolar Disorder determined by the MINI
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)
Immunodeficiency (immuno-compromised and immuno-suppressed participants; e.g. AIDS, lymphoma, participants undergoing long-term corticosteroid treatment, chemotherapy and allograft participants)
Unstable or severe medical conditions (e.g. cancer, cardiovascular, renal, lung, diabetes, psychiatric illness, bleeding disorders, etc.)
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
Electroconvulsive therapy (ECT) in the year prior to participation in the study
Taking medication or other not-permitted treatment that cannot be safely discontinued

Sites / Locations

Providence Care Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Probio'Stick

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Mood

Montgomery-Asberg Depression Rating Scale

Secondary Outcome Measures

Anxiety

Generalized Anxiety Disorder 7-item Scale

Anhedonia

Snaith Hamilton Pleasure Scale

Cognition

CNS Vital Signs

Cytokines

Blood plasma

Serotonin

Blood Plasma

Microbiome

Stool

Brain structure/function

fMRI

Full Information

NCT ID

NCT03277586

First Posted

September 1, 2017

Last Updated

January 13, 2021

Sponsor

Queen's University

1. Study Identification

Unique Protocol Identification Number

NCT03277586

Brief Title

Effects of Probiotics on Symptoms of Depression

Acronym

EPSD

Official Title

Effects of Probiotics on Symptoms of Depression

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Terminated

Why Stopped

COVID-19

Study Start Date

May 29, 2018 (Actual)

Primary Completion Date

November 30, 2020 (Actual)

Study Completion Date

November 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Queen's University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depression, Anxiety

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

16-week Double-blind randomized placebo-controlled dual-phase trial

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

28 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Probio'Stick

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Probio'Stick

Intervention Description

Probiotic supplement containing Lactobacillus helveticus and Bifidobacterium longum

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Identically formulated and packaged inactive substance

Primary Outcome Measure Information:

Title

Mood

Description

Montgomery-Asberg Depression Rating Scale

Time Frame

16 weeks

Secondary Outcome Measure Information:

Title

Anxiety

Description

Generalized Anxiety Disorder 7-item Scale

Time Frame

16 weeks

Title

Anhedonia

Description

Snaith Hamilton Pleasure Scale

Time Frame

16 weeks

Title

Cognition

Description

CNS Vital Signs

Time Frame

16 weeks

Title

Cytokines

Description

Blood plasma

Time Frame

16 weeks

Title

Serotonin

Description

Blood Plasma

Time Frame

16 weeks

Title

Microbiome

Description

Stool

Time Frame

16 weeks

Title

Brain structure/function

Description

fMRI

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

Eligibility Criteria

Inclusion Criteria: Diagnosis of Major Depressive Disorder (MDD) according to DSM-5 as determined by 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: Current use of any antidepressant drug Three or more previous episodes of depression Failure to respond to another treatment in the current episode 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. 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 dependence in the past 6 months Use of probiotic product in the past 2 weeks (may be eligible to participate after a 2-week washout period) and during the trial Use of any type of laxative Consumption of products fortified in probiotics 2 weeks before and during the trial High risk of suicide (score 4 or more on item 10 of MADRS) Psychotic symptoms determined by the MINI Bipolar Disorder determined by the MINI 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) Immunodeficiency (immuno-compromised and immuno-suppressed participants; e.g. AIDS, lymphoma, participants undergoing long-term corticosteroid treatment, chemotherapy and allograft participants) Unstable or severe medical conditions (e.g. cancer, cardiovascular, renal, lung, diabetes, psychiatric illness, bleeding disorders, etc.) 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 Electroconvulsive therapy (ECT) in the year prior to participation in the study Taking medication or other not-permitted treatment that cannot be safely discontinued

Facility Information:

Facility Name

Providence Care Hospital

City

Kingston

State/Province

Ontario

ZIP/Postal Code

K7L 4X3

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Effects of Probiotics on Symptoms of Depression

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