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Effect of Lactobacillus Plantarum 299v Supplementation on Major Depression Treatment

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ClinicalTrials.gov Identifier: NCT02469545
Recruitment Status : Completed
First Posted : June 11, 2015
Last Update Posted : September 7, 2018
Sponsor:
Information provided by (Responsible Party):
Medical University of Bialystok

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.

Condition or disease Intervention/treatment Phase
Depression Anxiety Disorder Drug: Lactobacillus Plantarum 299v Drug: Crystalline cellulose powder Drug: Escitalopram Drug: Sertraline Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Lactobacillus Plantarum 299v Supplementation on Major Depression Treatment
Study Start Date : June 2014
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Active Comparator: SSRI and probiotic
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).
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.

Drug: Escitalopram
5-20mg daily

Drug: Sertraline
50-100mg daily

Placebo Comparator: SSRI and placebo of probiotic
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).
Drug: 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.

Drug: Escitalopram
5-20mg daily

Drug: Sertraline
50-100mg daily




Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 Measures :
  1. Cognitive functions evaluation - California Verbal Learning Test (CVLT) [ Time Frame: At day one, after 8 weeks (day 56) of the study ]
  2. Cognitive functions evaluation - Ruff Figural Fluency Test (RFFT) [ Time Frame: At day one, after 8 weeks (day 56) of the study ]
  3. Cognitive functions evaluation - Stroop Test (A and B) [ Time Frame: At day one, after 8 weeks (day 56) of the study ]
  4. Cognitive functions evaluation - Connecting Points Test (A and B) [ Time Frame: At day one, after 8 weeks (day 56) of the study ]
  5. Cognitive functions evaluation - Attention and Perceptivity Test [ Time Frame: At day one, after 8 weeks (day 56) of the study ]
  6. Biochemical analysis - morning cortisol level [ Time Frame: At day one, after 8 weeks (day 56) of the study ]
    Biochemical analysis will be based on pro-inflammatory and anti-inflammatory cytokines measurements, morning cortisol concentration, tryptophan and its kynurenic pathway metabolites measurements.

  7. Biochemical analysis - cytokines measurements profile [ Time Frame: At day one, after 8 weeks (day 56) of the study ]
  8. Biochemical analysis - kynurenic pathway metabolites measurements profile [ Time Frame: At day one, after 8 weeks (day 56) of the study ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02469545


Locations
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Poland
Department of Psychiatry, Medical University of Bialystok
Bialystok, Poland
Sponsors and Collaborators
Medical University of Bialystok
Investigators
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Principal Investigator: Leszek Z Rudzki, MD Psychiatry Specialist Department of Psychiatry, Medical University of Bialystok
Study Director: Napoleon Waszkiewicz, MD PhD Psychiatry Department of Bialystok Medical University

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Responsible Party: Medical University of Bialystok
ClinicalTrials.gov Identifier: NCT02469545     History of Changes
Other Study ID Numbers: 133-47818
First Posted: June 11, 2015    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: August 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Medical University of Bialystok:
depression
microbiota-gut-brain axis
Lactobacillus Plantarum 299v
probiotic

Additional relevant MeSH terms:
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Depression
Depressive Disorder
Depressive Disorder, Major
Anxiety Disorders
Behavioral Symptoms
Mood Disorders
Mental Disorders
Antidepressive Agents
Citalopram
Sertraline
Serotonin Uptake Inhibitors
Dexetimide
Serotonin
Psychotropic Drugs
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Serotonin Receptor Agonists