Effect of Lactobacillus Plantarum 299v Supplementation on Major Depression Treatment

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effect of Lactobacillus Plantarum 299v Supplementation on Major Depression Treatment

Conditions
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Depression, Anxiety Disorder

Intervention / Treatment
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* Drug: Lactobacillus Plantarum 299v
* Drug: Crystalline cellulose powder
* Drug: Escitalopram
* Drug: Sertraline


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: SSRI and probiotic<br>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<br>* 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.<br>Drug: Escitalopram<br>* 5-20mg daily<br>Drug: Sertraline<br>* 50-100mg daily<br>|
| Placebo Comparator: SSRI and placebo of probiotic<br>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: Crystalline cellulose powder<br>* Administering antidepressant drug (SSRI - selective serotonin reuptake inhibitor) and placebo of probiotic - 2x1 placebo caps. filled with micro-crystalline cellulose powder for 8 weeks.<br>Drug: Escitalopram<br>* 5-20mg daily<br>Drug: Sertraline<br>* 50-100mg daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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depression, microbiota-gut-brain axis, Lactobacillus Plantarum 299v, probiotic