The Safety and Efficacy of Fecal Microbiota Transplantation in a Population With Major Depressive Disorder

Launched by UNIVERSITY OF CALGARY · Mar 16, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called fecal microbiota transplantation (FMT) in adults who have major depressive disorder (MDD) that has not responded to standard antidepressant medications. The goal is to see if this treatment can help improve symptoms of depression in those who have tried at least two different antidepressants without success. The trial is currently recruiting participants aged 18 to 65 who have been diagnosed with depression and have been on a stable antidepressant treatment for at least eight weeks.

Participants in this study can expect to undergo a procedure where beneficial bacteria from a healthy donor's stool are transferred to their gut to see if it improves their mood. To be eligible, individuals must have a specific score on a depression scale and should not have certain other mental health conditions or be taking specific medications that could interfere with the study. This trial is an important step in exploring new treatment options for those struggling with treatment-resistant depression, and it offers a chance to contribute to research that might help others in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• 1. 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
• • 2. Have a primary diagnosis of MDD according to the M.I.N.I. International Neuropsychiatric Interview (MINI)47
• • 3. 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
• • 4. Have been on a current treatment with a approved antidepressant at an adequate dose for at least 8 weeks
• • 5. 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.
• Exclusion Criteria:
• • 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