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Completed

NCT Number: NCT02469545

Effect of Lactobacillus Plantarum 299v Supplementation on Major Depression Treatment

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Psychiatry, Medical University of Bialystok

Bialystok, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Lactobacillus plantarum 299v

Drug

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 powder

Drug

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

Escitalopram

Drug

5-20mg daily

Sertraline

Drug

50-100mg daily

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. Cognitive functions evaluation - California Verbal Learning Test (CVLT)

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

  2. Cognitive functions evaluation - Ruff Figural Fluency Test (RFFT)

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

  3. Cognitive functions evaluation - Stroop Test (A and B)

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

  4. Cognitive functions evaluation - Connecting Points Test (A and B)

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

  5. Cognitive functions evaluation - Attention and Perceptivity Test

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

  6. Biochemical analysis - morning cortisol level

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

    Biochemical analysis will be based on pro-inflammatory and anti-inflammatory cytokines measurements, morning cortisol concentration, tryptophan and its kynurenic pathway metabolites measurements.

  7. Biochemical analysis - cytokines measurements profile

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

  8. Biochemical analysis - kynurenic pathway metabolites measurements profile

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

Sponsors and collaborators

Lead sponsor

Medical University of Bialystok

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jun 11, 2015
Registry last updated
Sep 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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