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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SSRI and probiotic | Active Comparator | 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 | Placebo Comparator | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactobacillus Plantarum 299v | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leszek Z Rudzki, MD Psychiatry Specialist | Department of Psychiatry, Medical University of Bialystok | Principal Investigator |
| Napoleon Waszkiewicz, MD PhD | Psychiatry Department of Bialystok Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Psychiatry, Medical University of Bialystok | Bialystok | Poland |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000089983 | Escitalopram |
| D020280 | Sertraline |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009570 | Nitriles |
| D001572 |
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| Crystalline cellulose powder | Drug | 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 | Drug | 5-20mg daily |
|
| Sertraline | Drug | 50-100mg daily |
|
| 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 | 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 |
| Biochemical analysis - cytokines measurements profile | At day one, after 8 weeks (day 56) of the study |
| Biochemical analysis - kynurenic pathway metabolites measurements profile | At day one, after 8 weeks (day 56) of the study |
| Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D015057 | 1-Naphthylamine |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |