Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 12:46 PM
Ignite Modification Date:
2025-12-24 @ 12:46 PM
NCT ID:
NCT06692361
Brief Summary:
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
Detailed Description:
This multicenter, randomized, double-blind, placebo-controlled study aims to compare the efficacy and safety of adjunctive FMT in patients with major depressive disorder (MDD) who show limited response to initial drug therapy.
A total of 600 patients experiencing depressive episodes will be screened, with all receiving escitalopram oxalate for an initial 2-week period. Of these, 214 participants who exhibit suboptimal therapeutic response to early antidepressant treatment will be enrolled and randomized in a 1:1 ratio to either the experimental group or control group.
During the intervention, participants will continue their existing antidepressant regimen and receive a 4-week treatment with either microbiota capsules or placebo. An additional 20-week follow-up assessment will then be conducted to evaluate outcomes.
Study:
NCT06692361
Study Brief:
Protocol Section:
NCT06692361