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

Phase 3

Completed

• Conditions: Major Depressive Disorder; Depressive Symptoms; Depression
• Interventions: Dietary Supplement: Probio'Stick

• Registration Number: NCT02838043
• Lead Sponsor: Queen's University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-06-02
• Study First Submitted QC: 2016-07-15
• Study First Posted: 2016-07-20
• Study Start: 2016-08
• Primary Completion: 2018-05
• Study Completion: 2018-05
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-13
• Last Update Posted: 2019-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Participant	Probio'Stick	All participants will be experimental and receive Probio'Stick.

Primary Outcome Measures

Name	Time	Method
Mood	8 weeks	Mood will be assessed with the Montgomery-Asberg Depression Rating Scale (MADRS) with a cut-off score of 12 indicating remission.

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Queen's University; 🇨🇦 Kingston, Ontario, Canada

Providence Care - Mental Health Services; 🇨🇦 Kingston, Ontario, Canada