Effect of Lactobacillus Plantarum 299v Supplementation on Major Depression Treatment

NCT02469545 | Completed Phase 2 DMC

• 1 other identifier: 133-47818
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Anxiety Disorder

Keywords

depression; microbiota-gut-brain axis; Lactobacillus Plantarum 299v; probiotic

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (8)

• 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

• 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

Study Arms (2)

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).

Drug: Lactobacillus Plantarum 299v; Drug: Escitalopram; Drug: Sertraline

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).

Drug: Crystalline cellulose powder; Drug: Escitalopram; Drug: Sertraline

Interventions

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.

SSRI and probiotic

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.

SSRI and placebo of probiotic

Escitalopram DRUG

5-20mg daily

SSRI and placebo of probiotic; SSRI and probiotic

Sertraline DRUG

50-100mg daily

SSRI and placebo of probiotic; SSRI and probiotic

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Medical University of Bialystok: lead

Study Sites (1)

Department of Psychiatry, Medical University of Bialystok

Bialystok, Poland

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders

Interventions

Escitalopram; Sertraline

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; 1-Naphthylamine; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2015
• First Posted: June 11, 2015
• Study Start: June 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: September 7, 2018

Record last verified: 2015-08

Locations

PL (1)