Effect of Lactobacillus Plantarum 299v Supplementation on Major Depression Treatment
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Evaluation of psychometric parameters - Change in Hamilton Depression Rating Scale from baseline at 3 weeks and 8 weeks of the study.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
- •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).
研究组 & 干预措施
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).
干预措施: Lactobacillus Plantarum 299v (Drug)
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).
干预措施: Escitalopram (Drug)
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).
干预措施: Sertraline (Drug)
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).
干预措施: Crystalline cellulose powder (Drug)
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).
干预措施: Escitalopram (Drug)
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).
干预措施: Sertraline (Drug)
结局指标
主要结局
Evaluation of psychometric parameters - Change in Hamilton Depression Rating Scale from baseline at 3 weeks and 8 weeks of the study.
时间窗: 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.
时间窗: 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.
时间窗: At day one, after 3 weeks (day 21), after 8 weeks (day 56) of the study
次要结局
- 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)
- Biochemical analysis - morning cortisol level(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)
- Biochemical analysis - cytokines measurements profile(At day one, after 8 weeks (day 56) of the study)