Status:
UNKNOWN
The Safety and Efficacy of Fecal Microbiota Transplantation in a Population With Major Depressive Disorder
Lead Sponsor:
University of Calgary
Collaborating Sponsors:
Cumming school of medicine
The W. Garfield Westin Foundation
Conditions:
Depression
Treatment Resistant Depression
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
Brief Summary
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).
Detailed Description
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 capsule...
Eligibility Criteria
Inclusion
- 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
- \- Participants who will be included in the IBS-D cohort should have a confirmed diagnosis of IBS-D as indicated by the referring gastroenterologist.
Exclusion
- 1\. 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 2. Regular intake of non-steroidal anti-inflammatory drugs, antibiotics, or iron supplements for medical purposes in the 3 months prior to study entry 3. Use of prebiotics or probiotics for medical purposes for more than 2 weeks within the last 3 months 4. Clinically diagnosed chronic gastrointestinal diseases (IBD, Crohn's disease, Ulcerative colitis, Celiac disease) 5. Conditions causing immune suppression 6. 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) 7. Reported allergy to Vancomycin or Nitazoxanide
Key Trial Info
Start Date :
March 4 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 4 2024
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04805879
Start Date
March 4 2021
End Date
December 4 2024
Last Update
November 28 2023
Active Locations (1)
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1
Cumming School of Medicine, University of Calgary
Calgary, Alberta, Canada, T2N 4 Z6