A Clinical Trial to Evaluate the Safety and Efficacy of Fecal Microbiota Transplantation in a Population With Major Depressive Disorder
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).
• 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.