Assessment of the Effectiveness and Safety of Fecal Microbiota Transplantation (FMT) in Patients With Major Depressive Disorder Who Do Not Show Early Improvement Following Antidepressant Treatment: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study

What this Trial Is About

Researchers are evaluating the use of fecal microbiota transplantation (FMT) as an additional treatment for patients with major depressive disorder (MDD) who show a limited early response to antidepressant medication. This randomized, double-blind, placebo-controlled study includes participants who have started treatment with the antidepressant escitalopram but have not improved sufficiently within the first two weeks. The study also investigates how FMT affects biological markers, including gut microbiota and related metabolites, in individuals with MDD. Participants first receive escitalopram for two weeks, after which those with less than 20% improvement are randomly assigned to one of two groups. One group continues escitalopram and takes daily oral FMT capsules derived from healthy human fecal microbiota for four weeks. The other group continues escitalopram and takes placebo capsules containing corn starch for the same period. Following the treatment phase, participants are monitored through a 20-week follow-up to assess outcomes. During the study, participants undergo regular evaluations including depression rating scales such as the Hamilton Depression Rating Scale (HAMD-17), as well as assessments of anxiety, sleep quality, cognitive function, and brain imaging including EEG. Safety and side effects are monitored throughout all study visits, which occur at baseline, week 4, week 8, week 12, and week 24. The primary measure of success is the rate of significant symptom improvement at various time points, with ongoing observation of remission rates and biological changes.

Assessment of the Efficacy and Safety of Fecal Microbiota Transplantation (FMT) in Patients With Major Depressive Disorder