Effect of Lactobacillus Plantarum 299v Supplementation on Major Depression Treatment

Medical University of Bialystok60 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Depression Anxiety Disorder

Interventions

Lactobacillus Plantarum 299vDRUG

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.

Crystalline cellulose powderDRUG

Administering antidepressant drug (SSRI - selective serotonin reuptake inhibitor) and placebo of probiotic - 2x1 placebo caps. filled with micro-crystalline cellulose powder for 8 weeks.

EscitalopramDRUG

5-20mg daily

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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).

Locations (1)

Department of Psychiatry, Medical University of Bialystok

Bialystok, Poland

Outcomes

Primary Outcomes

Evaluation of psychometric parameters - Change in Hamilton Depression Rating Scale from baseline at 3 weeks and 8 weeks of the study.

Time frame: 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.

Time frame: 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.

Time frame: At day one, after 3 weeks (day 21), after 8 weeks (day 56) of the study