The Safety, Efficacy, and Tolerability of Microbial Ecosystem Therapeutic-2 in People With Major Depression and/or Generalized Anxiety Disorder
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Montgomery-Asberg Depression Rating Scale (MADRS)
研究概览
简要总结
This study will measure the effects of MET-2 on symptoms of depression and anxiety using pre- and post-treatment scores for overall depression and anxiety and other symptoms of depression, such as sleep and anhedonia.
详细描述
This study will measure the effects of MET-2 on symptoms of depression and anxiety using pre- and post-treatment scores for overall depression and anxiety and other symptoms of depression, such as sleep and anhedonia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- 否
入选标准
- •Able to provide informed consent.
- •Not pregnant
- •Willing to participate in follow up as part of the study
- •Diagnosis of MDD and/or GAD by MINI
- •Current depressive episode with a MADRS score of ≥15 or Current GAD episode with GAD-7 score of ≥
- •Able to understand and comply with the requirements of the study
- •Able to provide stool and blood samples.
排除标准
- •History of chronic diarrhea
- •Need for regular use of agents that affect GI motility (narcotics such as codeine or morphine, agents such as loperamide or metoclopramide)
- •Elective surgery that will require preoperative antibiotics planned within 6 months of enrolment
- •Pregnant, breastfeeding, or planning to get pregnant in the next 6 months
- •Any condition for which, in the opinion of the investigator, the participant should be excluded from the study.
- •Current use of any antidepressant/antianxiety drug (eligible to participate after a 4-week washout period)
- •Use of any antibiotic drug in the past 4 weeks (may be eligible to participate after a 1-month washout period)
- •History of alcohol or substance dependence in the past 6 months
- •Daily use of probiotic product in the past 2 weeks (may be eligible to participate after a 2-week washout period)
- •Use of any type of laxative in the last 2 weeks.
- •Consumption of products fortified in probiotics
- •High suicidal risk, as measured by MADRS item 10 score more than 3 (or 4)
- •Current psychotic symptoms
- •Bipolar Depression
- •History of epilepsy or uncontrolled seizures
- •Immunodeficiency (immuno-compromised and immuno-suppressed participants; e.g. acquired immune deficiency syndrome [AIDS], lymphoma, participants undergoing long-term corticosteroid treatment, chemotherapy and allograft participants)
- •Unstable medical conditions or serious diseases/conditions (e.g. cancer, cardiovascular, renal, lung, diabetes, psychiatric illness, bleeding disorders, etc.)
- •The use of natural health products (Natural health products [NHPs]; e.g. St. John's Wort, passion flower, etc.) that affect depression
- •History of Electroconvulsive therapy (ECT)
研究组 & 干预措施
Generalized Anxiety Disorder
MET-2 will be given to subjects with generalized anxiety disorder and its effect on mood will be measured
干预措施: MET-2 (Biological)
Major Depression Disorder
MET-2 will be given to subjects with major depression disorder and its effect on mood will be measured
干预措施: MET-2 (Biological)
结局指标
主要结局
Montgomery-Asberg Depression Rating Scale (MADRS)
时间窗: Week 10
The MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders
Generalized Anxiety Disorder - 7 (GAD-7)
时间窗: Week 10
The GAD-7 is a seven domain, self-reported questionnaire for screening and assessing severity of generalized anxiety disorder.
次要结局
未报告次要终点