Effect of Lactobacillus Plantarum 299v Supplementation on Major Depression Treatment

Medical University of Bialystok

Status and phase: Completed; Phase 2

Conditions: Anxiety Disorder; Depression

Treatments: Drug: Escitalopram; Drug: Crystalline cellulose powder; Drug: Sertraline; Drug: Lactobacillus Plantarum 299v

Study type: Interventional

Funder types: Other

Identifiers

NCT02469545

133-47818

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

SSRI and probiotic

Active Comparator group

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).

Treatment:

Drug: Lactobacillus Plantarum 299v

Drug: Sertraline

Drug: Escitalopram

SSRI and placebo of probiotic

Placebo Comparator group

Description:

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).

Treatment:

Drug: Sertraline

Drug: Escitalopram

Drug: Crystalline cellulose powder