Major Depressive Disorder
Conditions
Interventions
Treatment group:IBNI617
placebo group:placebo
Sponsors
Shanghai Mental Health Center
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Meet the DSM-5 diagnostic criteria for depression (MDD); A single or repeated episode without psychotic symptoms; 2. Outpatient/inpatient patients; 3. Age 18-65 years old (including the threshold value), gender is not limited; 4. The HAMD-17 score of Hamilton Depression scale in screening and baseline was greater than or equal to 17 points; 5. The patient understands and voluntarily participates in the experiment, and inform Consent Form. 6. Have not consumed any probiotic-related food or medicine in the past 2 weeks; 7. No antibiotics, amiodarone, dopamine, bromocryptotine, phenytoin, lithium and other drugs have been taken in the past 2 weeks.
Exclusion criteria
Exclusion criteria: 1.A history of serious suicide attempts, or a current high risk of suicide, or HAMD (3) suicide score =3; 2. Currently have a DSM-5 diagnosis of other mental disorders other than depression [schizophrenia spectrum and other psychiatric disorders or bipolar and related disorders, anxiety disorders, compulsive and related disorders, somatic symptoms and related disorders, substance related and addiction disorders (except caffeine and nicotine), etc.], or a positive urine drug screening indicator at the time of screening; 3. Refractory depression as judged by the investigator or previously diagnosed (not effective after adequate treatment with 2 or more antidepressants); 4. The score reduction rate of HAMD17 scale in the baseline period was =25% compared with the screening period; 5. Depressive episodes secondary to other mental or physical illnesses; Bipolar disorder; Or depression with psychotic symptoms; 6. Serious or unstable heart, liver, kidney, endocrine (thyroid dysfunction), blood and other medical diseases; Patients with epilepsy or other organic brain disorders; 7. Presence of alcohol and substance dependence in the year prior to baseline; 8. Milk protein allergy, lactose intolerance; 9. Women who are breastfeeding, pregnant or at risk of becoming pregnant during the trial; Men with fertility requirements within half a year; 10. Abnormal ECG results or abnormal laboratory test results with clinical significance (e.g. Liver function exceeding 1.5 times the clinical upper limit, renal function exceeding the upper limit, blood sugar exceeding the upper limit, abnormal cardiac troponin cTn, and obvious abnormal thyroid test indicators); 11. Antidepressants were prescribed within 2 weeks before screening, and psychotropic drugs were stopped for less than 7 half-lives before randomization (monoamine oxidase inhibitors for at least 2 weeks, fluoxetine for at least 1 month); 12. Electrical convulsions or transcranial magnetic stimulation physical therapy in the past 3 months; 13. Have been undergoing systematic psychotherapy for the past 3 months; 14. Poor compliance and inability to take medicine as prescribed by the doctor; 15. Patients who have participated in clinical trials of other drugs within 30 days; 16. Participants considered inappropriate to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in the total score of HAMD-17 on the Hamilton Depression Scale before and after treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate of treatment Effectiveness = =50% reduction in HMAD score or =50% reduction in MADRS score Reduction rate =[(baseline score minus end point score)/baseline score]×100%;Clinical RESPONSE RATE Clinical remission = HAMD-17=7 or MADRS total score =12 at the end of treatment;Reduction rates of MADRS and HAMD17 scores;Changes in HAMD-17 in each group of subjects after 8 weeks of treatment;Changes or scores of the Clinical Global Impression Scale (CGI-S, CGI-I) scores in each group of subjects after 8 weeks of treatment;The fecal microbiome; Changes in gut microbial composition, abundance, and substance T at baseline at 2 and 4 to 8 weeks after intervention;Serum substance T; LC/MS mass spectrometry was used to detect the changes in serum substance T levels from baseline at 2 weeks, 4 weeks to 8 weeks after intervention; | — |
Countries
China
Contacts
Public ContactZhao Xue
Shanghai Mental Health Center
Outcome results
None listed