Major depressive disorder
Conditions
Interventions
rTMS combined with FMT group:Repetitive Transcranial Magnetic Stimulation combined with Fecal Microbiota Transplantation
Sponsors
Beijing An Ding Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. After evaluation by MINI 7.0.2, it meets the DSM-V criteria for major depressive disorder and does not have psychotic symptoms; 2. Age range: 18 - 55 years old, gender not limited; 3. No MECT/ECT, TMS, tDCS treatment within 1 month before enrollment; 4. No use of any psychiatric medication within 14 days before enrollment; The score of the 17-item Hamilton Depression Rating Scale (HAMD-17) at the time of enrollment was >= 17, and the score of item 1 (depressive mood) of HAMD-17 was >= 2; 5. Has understood all the research contents and signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Consistent with other mental disorder diagnoses in DSM-V; 2. Suffering from severe or unstable organic diseases; 3. Pregnant or lactating women, and patients who cannot take appropriate contraceptive measures during the trial; 4. Having a history of epileptic seizures, epilepsy, hydrocephalus or central nervous system tumors. Acute brain injury and infection; 5. With implanted electronic stimulators; 6. Those with a HAMD-17 item 3 (suicide) score of >= 3 points; 7. Patients with previous suicidal behavior or current strong suicidal tendencies; 8. Those who participated in any other clinical trial within 1 month before the baseline; 9. Having inflammatory-related diseases; 10. Having gastrointestinal infections, tumors and other structural abnormal digestive organ diseases, including but not limited to irritable bowel syndrome, Crohn's disease, ulcerative colitis, celiac disease, etc.; 11. Having a history of gastrointestinal surgery; 12. Using antibiotics, probiotics, prebiotics products or traditional Chinese medicine continuously for more than 2 weeks for medical purposes within 3 months before entering the study; 13. Allergic to the capsule components and contents; 14. Researchers consider that there are situations where participation in this study is inappropriate; 15. Researchers directly involved in this study or their immediate family members.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Differences in HAMD-17 score reductions: rTMS+FMT vs rTMS (2-weekend) & rTMS+FMT vs FMT; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in biological indicators such as microbiota and metabolites at each follow-up point compared;The change value of the total score of the GAD-7 scale at each follow-up point relative to the baseline total score;Differences in decrement, efficacy, and remission rate among three groups at the end of 4th and 8th week;Changes in cognitive function at each follow-up point;The change value of the total score of the GSRS scale at each follow-up point relative to the baseline total score of the scale;Safety indicators: Adverse event records;The change value of the total score of the QIDS-SR-16 scale at each follow-up point relative to the baseline total score of the scale;At the end of the 2nd week, there was a difference in the effective rate (HAMD subtraction rate =50%;Change from baseline in each subscale of PSQI at each follow-up point;Changes in fMRI, EEG and MEG at each follow-up point;The change value of the total score of the SDS scale at each follow-up point relative to the baseline total score of the scale; | — |
Countries
China
Contacts
Public ContactJingjing Zhou
Beijing An Ding Hospital, Capital Medical University
Outcome results
None listed