Probiotics to Treat "Inflammatory Depression" - a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Region Skane
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- "Inflammatory depressive symptoms"
研究概览
简要总结
The main aims of this project are to test if: i) Specific probiotic lactobacilli (added to stabilized ongoing treatment) are efficacious in treating depressive symptoms in individuals with low-grade inflammation, defined using high sensitivity C-reactive protein (hs-CRP) and BMI. ii) This effect is mediated through decrease of inflammation, estimated by treatment-associated changes in blood and faeces biomarkers. Secondary aims are to investigate the relationship between specific depressive symptoms and inflammation and if there is a correlation between certain pro-inflammatory or metabolic markers and depression.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Depressive episode according to the DSM-V
- •MADRS-M score >18
- •All subjects will be stable on an antidepressant medication or in Cognitive Behavioural Therapy (CBT) for >4 weeks
- •Subjects will be willing not to significantly alter their diet during the period of the study
- •A hs-CRP value ≥1mg/L and BMI >25
排除标准
- •Serious or unstable medical illness that in the investigator's opinion could compromise response to treatment or interpretation of study results.
- •Known or suspected allergy to the study compounds.
- •Ongoing infection.
- •A diagnosis of psychotic disorder, bipolar disorder, personality disorder mental retardation, dementia, or individual whom, due to other causes, lack the ability to make an informed decision.
- •Ongoing ECT.
- •Patients who, in the investigator's judgment, pose a current, serious suicidal.
- •A diagnosis for any Substance Use Disorder (except nicotine or caffeine) in the 3 months prior to the screening visit.
- •Any medications (within 1 week of baseline or during the trial) that might confound the biomarker findings, including: Regular ingestion of NSAIDs or COX-2 inhibitors, or any use of oral steroids, immunosuppressants, interferon, chemotherapy (Patients will be instructed not to take an NSAID, COX-2 inhibitor or Aspirin in the 24 hours prior to a biomarker assessment visit).
- •Antibiotic treatment/consumption within four (4) weeks before baseline visit.
- •Patients who have taken foods or supplements with Probiotics later than two (2) weeks before baseline visit.
- •Active participation in other clinical studies with ongoing study visits.
结局指标
主要结局
"Inflammatory depressive symptoms"
时间窗: 8 weeks
Total composite score of the following items from the Patient Health Questionnaire (PHQ-9): item 3 (sleep problems), item 4 (lack of energy), and item 5 (appetite disturbance)
Montgomery-Åsberg Depression Rating Scale (interview version)
时间窗: 8 weeks
Decrease in depressive symtoms indicated by lower total score on mentioned scale, with 10 items, ranging from 0-60, a higher score indicating increased severity
次要结局
- Insomnia Severity Index (ISI)(8 weeks)
- Gastrointestinal Symptom Rating Scale for Irritable Bowel Syndrome (GSRS-IBS)(8 weeks)
- Dimensional Anhedonia Rating Scale (DARS)(8 weeks)
- WHO Disability Assessment Schedule (WHODAS)(8 weeks)
- Generalized Anxiety Disorder-7 (GAD-7)(8 weeks)
- Fatigue Severity Scale (FSS)(8 weeks)
- Wechsler Adult Intelligence Scale (WAIS-IV)(8 weeks)
研究者
Daniel Lindqvist
MD, PhD, Ass Prof
Region Skane