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
This study aimed to evaluate the efficacy and safety of fecal microbiota transplantation (FMT) in patients with major depressive disorder (MDD) who exhibit suboptimal early response to antidepressant treatment. Additionally, it sought to investigate the impact of FMT on biological indicators, including intestinal microbiota and metabolites, in individuals with MDD
• Outpatient or inpatient, aged 18 to 65 years (inclusive), regardless of gender;
• At the start of the screening phase, participants must meet the Diagnostic and Statistical Manual of Mental Disorders-fifth edition (DSM-5) diagnostic criteria for recurrent major depressive disorder (MDD) or single-episode MDD;
• At the start of the screening phase, participants' score on the 17-item Hamilton Depression Rating Scale (HAMD-17) must be ≥ 17;
• At the start of the screening phase, participants have not been treated with medication for their current depressive episode;
• At the start of the screening phase, participants are intended to be treated with a single antidepressant medication, Escitalopram;
• The HAMD-17 score after two weeks of treatment with the maximum tolerated dose of escitalopram was reduced by less than 20% compared with the HAMD-17 score at screening;
• Participants must have an education level above primary school and be able to understand the content of the scale;
• Participants sign the informed consent form.