Major Depressive Disorder
Conditions
Interventions
Experimental group:Morinda officinalis oligosaccharide
Sponsors
Beijing Anding Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Outpatient patients, aged between 18 and 65 (including 18 and 65), gender is not limited; 2. Meet the Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5) diagnostic criteria for depression, either first episode or recurrence, without psychotic symptoms; 3. Screening and 17-item Hamilton Depression Scale (HAMD) scoring criteria at baseline: 14 <=HAMD-17 <=24; 4. For non-obese patients with BMI< 28, BMI= (weight kg) /(height m)2; 5. Primary school education or above, able to understand the content of the scale; 6. Understand and voluntarily participate in the study, and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. current or previous DSM-5 diagnosis other than depression; 2. Use of antibiotics or anti-inflammatory drugs, or probiotics and prebiotics in the past month; 3. Women in lactation or pregnancy or those who have fertility requirements (including men) during the trial, as well as men and women who are unable to take safe and effective contraceptive measures; 4. At present, patients have serious suicide risk, HAMD-17 suicide risk item >= 3 points; 5. Complicating with serious or unstable physical diseases, including any cardiovascular, tumor, renal, respiratory, endocrine (including thyroid dysfunction), digestive (inflammatory bowel disease, Crohn's disease, pancreatitis, partial or complete intestinal obstruction, etc.), hematologic (such as bleeding tendency) or nervous system diseases; 6. Patients who are taking antipsychotics, antidepressants, and mood stabilizers and have less than 5 half-lives before baseline; 7. Taking other Chinese patent medicines or decoction that have therapeutic effect on depressive symptoms; 8. Those who cannot take medicine as prescribed by the doctor; 9. Those who had previously failed to take Morinda officinalis oligosaccharide capsules and escitalopram tablets or were allergic to Morinda officinalis oligosaccharide and escitalopram tablets; 10. Alcohol or drug abuse within 6 months before screening; 11. Unable to swallow oral medicine; 12. Patients with other conditions deemed unsuitable for enrolment by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of score of Hamilton Depression Scale-17 compared with baseline assessment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Intestinal flora;Blood and fecal metabolites;Change of score of Depression Symptoms Rapid Self-Assessment Scale16 compared with baseline assessment;Change of score of Generalized Anxiety Disorder Scale-7 compared with baseline assessment; | — |
Countries
China
Contacts
Public ContactWang Gang
Beijing Anding Hospital, Capital Medical University
Outcome results
None listed