Major depressive disorder
Conditions
Interventions
Experiment group:Escitalopram+ FMT (0-2W)
Escitalopram (3W-8W)
Control group:Escitalopram+ placebo (0-2W)
Sponsors
Beijing Anding Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria (all of the following must be met): 1. Meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnostic criteria for Major Depressive Disorder (MDD); 2. Outpatients or inpatients aged 18 to 65 years (including 18 and 65 years), with no gender restrictions; 3. BMI:18-24 kg/m^2; 4. Patients who have not taken antidepressant medication for at least 14 days prior to enrollment (fluoxetine at least 28 days); 5. Total scores of the 17-Item Hamilton Rating Scale for Depression (HAMD-17) >= 17; 6. Patients who are able to understand and comply with the research requirements, and sign an informed consent form.
Exclusion criteria
Exclusion criteria: Exclusion criteria (meeting any one criterion is sufficient for exclusion): 1. Current or past diagnosis of mental disorders other than MDD diagnosed according to the MINI diagnostic criteria; 2. History of current or past substance abuse; 3. Item 3 of HAMD-17 (the suicide risk item) >= 3, indicating patients with serious suicide tendencies; 4. This depressive episode is accompanied by psychotic symptoms; 5. Current severe or unstable conditions requiring medication or surgical treatment; 6. Current medical conditions such as acute infectious disease; 7. Patients with gastrointestinal organic diseases due to infection, neoplasm, or other structural abnormalities, including but not limited to Irritable Bowel Syndrome, Crohn’s disease, Ulcerative Colitis, and Celiac disease; 8. Patients with a history of gastrointestinal surgery; 9. Current or recent use of antibiotics, probiotics, or prebiotics for medical (within 3 months before inclusion); 10. Individuals who have been allergic or ineffective to taking escitalopram in the past; 11. Those allergic to the components of the capsule and its contents; 12. Patients who are using antipsychotics, antidepressants, and mood stabilizers with a pre baseline cleaning period of less than 5 half-lives; 13. Pregnancy, breast-feeding; 14. Inability (e.g. dysphagia) to or unwilling to swallow capsules; 15. Patients receiving MECT treatment in the past six months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of subjects in remission (HAMD-17<=7) at week 8; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportions of responders (>=50% reduction from baseline in HAMD-17 total score) at week 8;Proportions of responders(>=50% reduction from baseline in HAMD-17 total score) through the end of FMT treatment at week 2;Change from baseline in subjective-reported depressive symptoms using the QIDS-SR16 at each visit;Change from baseline in subjective-reported anxiety symptoms using the GAD-7 at each visit;Change from baseline in gastrointestinal symptoms using GSRS at each visit;Change from baseline in subscale of HAMD-17;Change from baseline in gut microbiota and metabolism at week 2 and week 8 ; | — |
Countries
China
Contacts
Public ContactYang Jian
Beijing Anding Hospital, Capital Medical University
Outcome results
None listed