Effect of Lactobacillus Plantarum 299v Supplementation on Major Depression Treatment

Depression Clinical Trial

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

Status Completed

Clinical Trial Summary

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Anxiety Disorder
• Anxiety Disorders
• Depression
• Depressive Disorder
• Depressive Disorder, Major

• NCT number: NCT02469545
• Study type: Interventional
• Source: Medical University of Bialystok
• Status: Completed
• Phase: Phase 2
• Start date: June 2014
• Completion date: March 2016