Back to results

Effect of Lactobacillus Plantarum 299v Supplementation on Major Depression Treatment

Primary Purpose

Depression, Anxiety Disorder

Status

Completed

Phase

Phase 2

Locations

Poland

Study Type

Interventional

Intervention

Lactobacillus Plantarum 299v

Crystalline cellulose powder

Escitalopram

Sertraline

About this trial

This is an interventional treatment trial for Depression focused on measuring depression, microbiota-gut-brain axis, Lactobacillus Plantarum 299v, probiotic

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

Department of Psychiatry, Medical University of Bialystok

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

SSRI and probiotic

SSRI and placebo of probiotic

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

Evaluation of psychometric parameters - Change in Hamilton Depression Rating Scale from baseline at 3 weeks and 8 weeks 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.

Evaluation of psychometric parameters - Change in Symptom Checklist 90 Scale (SCL-90) from baseline at 3 weeks and 8 weeks of the study.

Secondary Outcome Measures

Cognitive functions evaluation - California Verbal Learning Test (CVLT)

Cognitive functions evaluation - Ruff Figural Fluency Test (RFFT)

Cognitive functions evaluation - Stroop Test (A and B)

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

Cognitive functions evaluation - Attention and Perceptivity Test

Biochemical analysis - morning cortisol level

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 - cytokines measurements profile

Biochemical analysis - kynurenic pathway metabolites measurements profile

Full Information

NCT ID

NCT02469545

First Posted

May 29, 2015

Last Updated

September 6, 2018

Sponsor

Medical University of Bialystok

1. Study Identification

Unique Protocol Identification Number

NCT02469545

Brief Title

Effect of Lactobacillus Plantarum 299v Supplementation on Major Depression Treatment

Official Title

Effect of Lactobacillus Plantarum 299v Supplementation on Major Depression Treatment

Study Type

Interventional

2. Study Status

Record Verification Date

August 2015

Overall Recruitment Status

Completed

Study Start Date

June 2014 (undefined)

Primary Completion Date

March 2016 (Actual)

Study Completion Date

March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Medical University of Bialystok

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depression, Anxiety Disorder

Keywords

depression, microbiota-gut-brain axis, Lactobacillus Plantarum 299v, probiotic

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SSRI and probiotic

Arm Type

Active Comparator

Arm Description

Arm Title

SSRI and placebo of probiotic

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Lactobacillus Plantarum 299v

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Crystalline cellulose powder

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Escitalopram

Intervention Description

5-20mg daily

Intervention Type

Drug

Intervention Name(s)

Sertraline

Intervention Description

50-100mg daily

Primary Outcome Measure Information:

Title

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

Title

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

Title

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 Outcome Measure Information:

Title

Cognitive functions evaluation - California Verbal Learning Test (CVLT)

Time Frame