Department of Psychiatry, Medical University of Bialystok
Bialystok, Poland
NCT Number: NCT02469545
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.
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Notify Me18 year–65 year
All sexes
Interventional
Phase 2
Bialystok, Poland
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Administering antidepressant drug (SSRI - selective serotonin reuptake inhibitor) and placebo of probiotic - 2x1 placebo caps. filled with micro-crystalline cellulose powder for 8 weeks.
5-20mg daily
50-100mg daily
Time frame: At day one, after 3 weeks (day 21), after 8 weeks (day 56) of the study
Time frame: At day one, after 3 weeks (day 21), after 8 weeks (day 56) of the study
Time frame: At day one, after 3 weeks (day 21), after 8 weeks (day 56) of the study
Time frame: At day one, after 8 weeks (day 56) of the study
Time frame: At day one, after 8 weeks (day 56) of the study
Time frame: At day one, after 8 weeks (day 56) of the study
Time frame: At day one, after 8 weeks (day 56) of the study
Time frame: At day one, after 8 weeks (day 56) of the study
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.
Time frame: At day one, after 8 weeks (day 56) of the study
Time frame: At day one, after 8 weeks (day 56) of the study
Medical University of Bialystok
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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