Effect of Lactobacillus Plantarum 299v Supplementation on Major Depression Treatment

Phase 2

Completed

• Conditions: Depression; Anxiety Disorder
• Interventions: Drug: Crystalline cellulose powder; Drug: Lactobacillus Plantarum 299v; Drug: Escitalopram; Drug: Sertraline

• Registration Number: NCT02469545
• Lead Sponsor: Medical University of Bialystok

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2015-05-29
• Study First Submitted QC: 2015-06-08
• Study First Posted: 2015-06-11
• Status Verified: 2015-08
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Last Update Submitted: 2018-09-06
• Last Update Posted: 2018-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SSRI and placebo of probiotic	Crystalline cellulose powder	Administering antidepressant drug (SSRI - selective serotonin reuptake inhibitor: Escitalopram or Sertraline) and placebo of probiotic (crystalline cellulose powder) to a group of patients diagnosed with depression (n=30).
SSRI and placebo of probiotic	Escitalopram	Administering antidepressant drug (SSRI - selective serotonin reuptake inhibitor: Escitalopram or Sertraline) and placebo of probiotic (crystalline cellulose powder) to a group of patients diagnosed with depression (n=30).
SSRI and probiotic	Lactobacillus Plantarum 299v	Administering antidepressant drug (SSRI - selective serotonin reuptake inhibitor: Escitalopram or Sertraline) and probiotic (Lactobacillus Plantarum 299v) to a group of patients diagnosed with depression (n=30).
SSRI and probiotic	Escitalopram	Administering antidepressant drug (SSRI - selective serotonin reuptake inhibitor: Escitalopram or Sertraline) and probiotic (Lactobacillus Plantarum 299v) to a group of patients diagnosed with depression (n=30).
SSRI and probiotic	Sertraline	Administering antidepressant drug (SSRI - selective serotonin reuptake inhibitor: Escitalopram or Sertraline) and probiotic (Lactobacillus Plantarum 299v) to a group of patients diagnosed with depression (n=30).
SSRI and placebo of probiotic	Sertraline	Administering antidepressant drug (SSRI - selective serotonin reuptake inhibitor: Escitalopram or Sertraline) and placebo of probiotic (crystalline cellulose powder) to a group of patients diagnosed with depression (n=30).

Primary Outcome Measures

Name	Time	Method
Evaluation of psychometric parameters - Change in Hamilton Depression Rating Scale from baseline at 3 weeks and 8 weeks of the study.	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.	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.	At day one, after 3 weeks (day 21), after 8 weeks (day 56) of the study

Secondary Outcome Measures

Name	Time	Method
Cognitive functions evaluation - California Verbal Learning Test (CVLT)	At day one, after 8 weeks (day 56) of the study
Cognitive functions evaluation - Ruff Figural Fluency Test (RFFT)	At day one, after 8 weeks (day 56) of the study
Cognitive functions evaluation - Stroop Test (A and B)	At day one, after 8 weeks (day 56) of the study
Cognitive functions evaluation - Connecting Points Test (A and B)	At day one, after 8 weeks (day 56) of the study
Cognitive functions evaluation - Attention and Perceptivity Test	At day one, after 8 weeks (day 56) of the study
Biochemical analysis - morning cortisol level	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.
Biochemical analysis - kynurenic pathway metabolites measurements profile	At day one, after 8 weeks (day 56) of the study
Biochemical analysis - cytokines measurements profile	At day one, after 8 weeks (day 56) of the study

Trial Locations

Locations (1)

Department of Psychiatry, Medical University of Bialystok; 🇵🇱 Bialystok, Poland