Clinical trial NCT02469545: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Depression
Anxiety Disorder
Keywords: depression
microbiota-gut-brain axis
Lactobacillus Plantarum 299v
probiotic
Lead sponsor: Medical University of Bialystok
Sponsor class: OTHER
First posted: 2015-06-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Evaluation of psychometric parameters - Change in Hamilton Depression Rating Scale from baseline at 3 weeks and 8 weeks of the study.
timeFrame: At day one, after 3 weeks (day 21), after 8 weeks (day 56) of the study
measure: Evaluation of psychometric parameters - Change in Perceived Stress Scale (PSS-10) from baseline at 3 weeks and 8 weeks of the study.
timeFrame: At day one, after 3 weeks (day 21), after 8 weeks (day 56) of the study
measure: Evaluation of psychometric parameters - Change in Symptom Checklist 90 Scale (SCL-90) from baseline at 3 weeks and 8 weeks of the study.
timeFrame: At day one, after 3 weeks (day 21), after 8 weeks (day 56) of the study
Secondary outcomes:
measure: Cognitive functions evaluation - California Verbal Learning Test (CVLT)
timeFrame: At day one, after 8 weeks (day 56) of the study
measure: Cognitive functions evaluation - Ruff Figural Fluency Test (RFFT)
timeFrame: At day one, after 8 weeks (day 56) of the study
measure: Cognitive functions evaluation - Stroop Test (A and B)
timeFrame: At day one, after 8 weeks (day 56) of the study
measure: Cognitive functions evaluation - Connecting Points Test (A and B)
timeFrame: At day one, after 8 weeks (day 56) of the study
measure: Cognitive functions evaluation - Attention and Perceptivity Test
timeFrame: At day one, after 8 weeks (day 56) of the study
measure: Biochemical analysis - morning cortisol level
timeFrame: At day one, after 8 weeks (day 56) of the study
measure: Biochemical analysis - cytokines measurements profile
timeFrame: At day one, after 8 weeks (day 56) of the study
measure: Biochemical analysis - kynurenic pathway metabolites measurements profile
timeFrame: At day one, after 8 weeks (day 56) of the study
Other outcomes:
Locations:
city: Bialystok
country: Poland
facility: Department of Psychiatry, Medical University of Bialystok
Study officials:
affiliation: Department of Psychiatry, Medical University of Bialystok
name: Leszek Z Rudzki, MD Psychiatry Specialist
role: PRINCIPAL_INVESTIGATOR
affiliation: Psychiatry Department of Bialystok Medical University
name: Napoleon Waszkiewicz, MD PhD
role: STUDY_DIRECTOR
References: