Effect of Lactobacillus Plantarum 299v Supplementation on Major Depression Treatment

The aim of the study is to determine the influence of supplementation of probiotic Lactobacillus Plantarum 299V vs. placebo of probiotic during antidepressant monotherapy with SSRI (Selective Serotonin Reuptake Inhibitor) in patients with major depression.

Study Overview

• Status: Completed
• Conditions: Depression; Anxiety Disorder
• Intervention / Treatment: Drug: Lactobacillus Plantarum 299v; Drug: Escitalopram; Drug: Sertraline; Drug: Crystalline cellulose powder

Detailed Description

For period of 8 weeks patient will receive probiotic Lactobacillus Plantarum 299V or its placebo as a supplementation of regular depression treatment with SSRI (Escitalopram or Sertraline). Psychometric and biochemical parameters will be monitored and evaluated. At day one, after 3 weeks (day 21) and after 8 weeks (day 56) of the study psychometric parameters will be measured such as Hamilton Depression Rating Scale, PSS-10 Scale, SCL-90 scale. At day one and after 8 weeks (day 56) of the study cognitive functions will be measured using: CVLT- California Verbal Learning Test, RFFT Ruff Figural Fluency Test, Stroop Test, Connecting Points Test (A and B), Attention and Perceptivity Test. At day one and after 8 weeks (day 56) of the study biochemical parameters will be measured such as: morning cortisol, pro and anti-inflammatory cytokines, tryptophan and its kynurenic pathway metabolites concentrations.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• Poland
  • Bialystok, Poland
    • Department of Psychiatry, Medical University of Bialystok

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Unipolar depression, with at least one depressive episode, present episode since at least 2 weeks, with Hamilton Depression Scale scoring 18 and higher with BMI =18,9 - 29,9 kg/m2

Exclusion Criteria:

• Inflammatory diseases eg. rheumatoid diseases, inflammatory bowel diseases, autoimmunological diseases
• Metabolic diseases e.g. diabetes type I,II, obesity (Body Mass Index)>30 kg/m2
• Previously diagnosed other psychiatric diseases other than depression, psychoactive substances abuse, organic brain dysfunctions
• Smokers
• Patients after surgeries in last 3 months
• Oncological patients
• Patients during pregnancy or lactation
• Drugs which might influence measured parameters (e.g. lithium, antibiotics, glucocorticosteroids, antipsychotic drugs)
• Changes in routine blood biochemical parameters: morphology, electrolytes, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), creatinine, urea, C-reactive protein (CRP), thyroid-stimulating hormone (TSH).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: SSRI and probiotic; Administering antidepressant drug (SSRI - selective serotonin reuptake inhibitor: Escitalopram or Sertraline) and probiotic (Lactobacillus Plantarum 299v) to a group of patients diagnosed with depression (n=30).	Drug: Lactobacillus Plantarum 299v; Administering antidepressant drug (SSRI - selective serotonin reuptake inhibitor) and probiotic - 2x1 caps. per day of Lactobacillus Plantarum 299V (10mld colony forming units in 1 caps.) for 8 weeks.; Drug: Escitalopram; 5-20mg daily; Drug: Sertraline; 50-100mg daily
Placebo Comparator: SSRI and placebo of probiotic; Administering antidepressant drug (SSRI - selective serotonin reuptake inhibitor: Escitalopram or Sertraline) and placebo of probiotic (crystalline cellulose powder) to a group of patients diagnosed with depression (n=30).	Drug: Escitalopram; 5-20mg daily; Drug: Sertraline; 50-100mg daily; Drug: Crystalline cellulose powder; Administering antidepressant drug (SSRI - selective serotonin reuptake inhibitor) and placebo of probiotic - 2x1 placebo caps. filled with micro-crystalline cellulose powder for 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evaluation of psychometric parameters - Change in Hamilton Depression Rating Scale from baseline at 3 weeks and 8 weeks of the study.	At day one, after 3 weeks (day 21), after 8 weeks (day 56) of the study
Evaluation of psychometric parameters - Change in Perceived Stress Scale (PSS-10) from baseline at 3 weeks and 8 weeks of the study.	At day one, after 3 weeks (day 21), after 8 weeks (day 56) of the study
Evaluation of psychometric parameters - Change in Symptom Checklist 90 Scale (SCL-90) from baseline at 3 weeks and 8 weeks of the study.	At day one, after 3 weeks (day 21), after 8 weeks (day 56) of the study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive functions evaluation - California Verbal Learning Test (CVLT)		At day one, after 8 weeks (day 56) of the study
Cognitive functions evaluation - Ruff Figural Fluency Test (RFFT)		At day one, after 8 weeks (day 56) of the study
Cognitive functions evaluation - Stroop Test (A and B)		At day one, after 8 weeks (day 56) of the study
Cognitive functions evaluation - Connecting Points Test (A and B)		At day one, after 8 weeks (day 56) of the study
Cognitive functions evaluation - Attention and Perceptivity Test		At day one, after 8 weeks (day 56) of the study
Biochemical analysis - morning cortisol level	Biochemical analysis will be based on pro-inflammatory and anti-inflammatory cytokines measurements, morning cortisol concentration, tryptophan and its kynurenic pathway metabolites measurements.	At day one, after 8 weeks (day 56) of the study
Biochemical analysis - cytokines measurements profile		At day one, after 8 weeks (day 56) of the study
Biochemical analysis - kynurenic pathway metabolites measurements profile		At day one, after 8 weeks (day 56) of the study

Collaborators and Investigators

• Sponsor: Medical University of Bialystok
• Investigators: Principal Investigator: Leszek Z Rudzki, MD Psychiatry Specialist, Department of Psychiatry, Medical University of Bialystok; Study Director: Napoleon Waszkiewicz, MD PhD, Psychiatry Department of Bialystok Medical University

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: May 29, 2015
• First Submitted That Met QC Criteria: June 8, 2015
• First Posted (Estimate): June 11, 2015

Study Record Updates

• Last Update Posted (Actual): September 7, 2018
• Last Update Submitted That Met QC Criteria: September 6, 2018
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: depression; probiotic; microbiota-gut-brain axis; Lactobacillus Plantarum 299v
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Anxiety Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Antidepressive Agents, Second-Generation; Sertraline; Citalopram
• Other Study ID Numbers: 133-47818

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided