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Effect of Lactobacillus Plantarum 299v Supplementation on Major Depression Treatment

NCT02469545 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2018-09-07

No results posted yet for this study

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.

Conditions

Interventions

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

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.

DRUG

Escitalopram

5-20mg daily

DRUG

Sertraline

50-100mg daily

Sponsors & Collaborators

  • Medical University of Bialystok

    lead OTHER

Principal Investigators

  • Leszek Z Rudzki, MD Psychiatry Specialist · Department of Psychiatry, Medical University of Bialystok

  • Napoleon Waszkiewicz, MD PhD · Psychiatry Department of Bialystok Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2016-03-31
Completion
2016-03-31

Countries

  • Poland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02469545 on ClinicalTrials.gov