Effect of Lactobacillus Plantarum 299v Supplementation on Major Depression Treatment

Depression Clinical Trial

Official title:

Effect of Lactobacillus Plantarum 299v Supplementation on Major Depression Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02469545
• Other study ID #: 133-47818
• Status: Completed
• Phase: Phase 2
• Start date: June 2014
• Est. completion date: March 2016

Study information

• Verified date: August 2015
• Source: Medical University of Bialystok
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Anxiety Disorder
• Anxiety Disorders
• Depression
• Depressive Disorder
• Depressive Disorder, Major

Intervention

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.
• 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.
• Escitalopram
5-20mg daily
• Sertraline
50-100mg daily

Locations

Country	Name	City	State
Poland	Department of Psychiatry, Medical University of Bialystok	Bialystok

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Bialystok

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Cognitive functions evaluation - California Verbal Learning Test (CVLT)		At day one, after 8 weeks (day 56) of the study
Secondary	Cognitive functions evaluation - Ruff Figural Fluency Test (RFFT)		At day one, after 8 weeks (day 56) of the study
Secondary	Cognitive functions evaluation - Stroop Test (A and B)		At day one, after 8 weeks (day 56) of the study
Secondary	Cognitive functions evaluation - Connecting Points Test (A and B)		At day one, after 8 weeks (day 56) of the study
Secondary	Cognitive functions evaluation - Attention and Perceptivity Test		At day one, after 8 weeks (day 56) of the study
Secondary	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.	At day one, after 8 weeks (day 56) of the study
Secondary	Biochemical analysis - cytokines measurements profile		At day one, after 8 weeks (day 56) of the study
Secondary	Biochemical analysis - kynurenic pathway metabolites measurements profile		At day one, after 8 weeks (day 56) of the study