Effect of Lactobacillus Plantarum 299v Supplementation on Major Depression Treatment

• Status: Completed
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Medical University of Bialystok
• Treatments: Antidepressive Agents; Citalopram; Dexetimide; Serotonin; Serotonin Uptake Inhibitors; Sertraline

Criteria

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).