Major depressive disorder with anhedonia
Conditions
Interventions
Placebo group:Escitalopram plus matching placebo powder
Probiotic group:Escitalopram plus Bifidobacterium longum subsp. longum probiotic powder
Sponsors
Beijing An Ding Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1.Diagnosed with major depressive disorder according to DSM-5 criteria by the investigator and confirmed using the Mini-International Neuropsychiatric Interview (MINI), either first episode or recurrent episode, without psychotic symptoms; 2.Aged 18–55 years, male or female; 3.If antidepressants were used before enrollment, a washout period of at least five half-lives is required before enrollment; 4.HAMD-17 score =17 at both screening and baseline; clinically significant anhedonia defined as a SHAPS score =3 at screening according to the original binary scoring method; 5.Able to understand and comply with study requirements and willing to sign written informed consent.
Exclusion criteria
Exclusion criteria: 1.Current or previous diagnosis of major psychiatric disorders other than depressive disorder according to MINI; 2.Current or previous substance abuse; 3.Current severe suicide risk, defined as HAMD-17 suicide item score =3; 4.Unstable physical disease requiring medication or surgical treatment; 5.Gastrointestinal infection, tumor, or other organic gastrointestinal disease with structural abnormalities; 6.Inflammation-related diseases; 7.History of gastrointestinal surgery; 8.Use of any probiotics, prebiotics, or laxatives within 1 month before enrollment, or antibiotics within 12 weeks before enrollment; 9.Previous allergy or nonresponse to escitalopram; 10.Allergy to the study powder ingredients or contents; 11.Current use of antipsychotics, antidepressants, or mood stabilizers without a washout period of at least five half-lives before baseline; 12.Pregnancy or lactation. 13. Used any antibiotic drugs within the 12 weeks before entering the study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HAMD-17 total score from baseline to week 8; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in TEPS total score from baseline;Clinical response rate at week 2;Clinical response rate at week 8;Clinical response rate at week 4;Change in related metabolite levels from baseline;Change in gut microbiota composition from baseline;Change in QIDS-SR16 total score from baseline;Change in GSRS total score from baseline;Change in SHAPS total score from baseline;Change in GAD-7 total score from baseline;Clinical remission rate at week 8; | — |
Countries
China
Contacts
Public ContactYang Jian
Beijing An Ding Hospital, Capital Medical University
Outcome results
None listed