A Clinical Trial to Evaluate the Safety and Efficacy of Fecal Microbiota Transplantation in a Population With Major Depressive Disorder
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Change in the MADRS total score
研究概览
简要总结
The primary goals of this proof of concept clinical trial are to determine the effectiveness, safety and tolerability of oral FMT in adults with Treatment Resistant Depression (TRD).
详细描述
This study is a phase 2/3, double-blinded, randomized controlled trial (RCT) in which 80 adults with TRD being treated with an approved antidepressant medication will be assigned to either FMT capsules or identically appearing placebo capsules. Participant will be followed for f for 14 weeks post FMT. This extended observation period will allow us to see, whether FMT leads to sustainable improvements in depression and changes in intestinal microbiome
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
- Triple (Participant, Care Provider, Investigator)
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
- •Between 18-65 years of age:
- •Participants should be at least 18 years old and not older than 65 years at the day of screening
- •Have a primary diagnosis of MDD according to the M.I.N.I. International Neuropsychiatric Interview (MINI)47
- •Medical history suggestive of Treatment Resistant Depression (TRD). (inadequate response to at least 2 approved antidepressants. at least one of which is in the current episode of depression)48
- •Have been on a current treatment with a approved antidepressant at an adequate dose for at least 8 weeks
- •A MADRS score of ≥ 19 at screening and visit 2
- •Additional Inclusion Criteria:
- •Participants who will be included in the IBS-D cohort should have a confirmed diagnosis of IBS-D as indicated by the referring gastroenterologist.
排除标准
- •Participant meets Diagnostic and Statistical Manual of Mental Disorders (DSM-5)1 Criteria for the following conditions according to the M.I.N.I: f) Substance Use Disorder within the last 3 months. *(Criteria should include Alcohol and non-alcohol substances except Cannabis) g) Moderate or severe Substance use disorder for Cannabis use the last 3 months h) Active Anorexia Nervosa or Bulimia nervosa i) Schizophrenia or schizoaffective disorder j) Active suicidality
- •Regular intake of non-steroidal anti-inflammatory drugs, antibiotics, or iron supplements for medical purposes in the 3 months prior to study entry
- •Use of prebiotics or probiotics for medical purposes for more than 2 weeks within the last 3 months
- •Clinically diagnosed chronic gastrointestinal diseases (IBD, Crohn's disease, Ulcerative colitis, Celiac disease)
- •Conditions causing immune suppression
- •Not breastfeeding, pregnant or seeking to get pregnant during the course of this study. Be using an acceptable method of birth control (implants, injectable, combined oral contraceptives, IUDs, sexual abstinence or a vasectomized partner)
- •Reported allergy to Vancomycin or Nitazoxanide
结局指标
主要结局
Change in the MADRS total score
时间窗: from baseline (pre-intervention) to the final visit (week 13)
To evaluate the effectiveness of adjunct oral FMT as compared to placebo with currently accepted approved therapy for depression
次要结局
- GI tolerability of patients with Irritable Bowel Syndrome (IBS)(from baseline (pre-intervention) to the final visit (week 13))
- Side effects as reported on the Toronto Side Effect Scale (TSES)(from baseline (pre-intervention) to the final visit (week 13))
研究者
Valerie Taylor
Head of Psychiatry
University of Calgary