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

NCT02838043 | Completed Phase 3

• 1 other identifier: 6016312
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

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.

Conditions

Major Depressive Disorder; Depression; Depressive Symptoms

Outcome Measures

Primary Outcomes (1)

• Mood

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

  8 weeks

Secondary Outcomes (4)

• Anxiety

  8 weeks

• Cognition

  8 weeks

• Sleep

  8 weeks

• Plasma

  8 weeks

Study Arms (1)

Participant

EXPERIMENTAL

All participants will be experimental and receive Probio'Stick.

Dietary Supplement: Probio'Stick

Interventions

Probio'Stick DIETARY_SUPPLEMENT

A combination of the probiotic strains Lactobacillus helveticus and Bifidobacterium longum

Participant

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Queen's University: lead
• Lallemand Health Solutions: collaborator
• McMaster University: collaborator

Study Sites (2)

Queen's University

Kingston, Ontario, K7L 3N6, Canada

Location

Providence Care - Mental Health Services

Kingston, Ontario, K7L 4X3, Canada

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Roumen Milev, PhD, MD

  Queen's University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Psychiatrist

Study Record Dates

• First Submitted: June 2, 2016
• First Posted: July 20, 2016
• Study Start: August 1, 2016
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: June 14, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)