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

Queen's University10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Major Depressive Disorder Depression Depressive Symptoms

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (2)

Queen's University

Kingston, Ontario, Canada

Providence Care - Mental Health Services

Kingston, Ontario, Canada

Outcomes

Primary Outcomes

Mood

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 Outcomes

Anxiety

Anxiety will be assessed with the Generalized Anxiety Disorder Scale (GAD-7).

Time frame: 8 weeks

Cognition

Cognition will be assess with the Digit Symbol Substitution Test (DSST).

Time frame: 8 weeks

Sleep

Sleep will be assessed objectively using a polysomnogram to look at changes electrophysiological sleep architecture after 8 weeks of treatment.

Time frame: 8 weeks

Plasma

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