Depression with fatigue symptoms
Conditions
Interventions
Treatment Group:Warming Yang and Resolving Depression decoction granules (twice daily, one bag per dose) combined with escitalopram
Control Group:TCM simulation placebo (dextrin + bitter principle) combined with the same dose of escitalopram
Sponsors
Beijing Anding Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Meet the diagnostic criteria for a depressive episode; present with fatigue symptoms (FS-14 score =6); have mild to moderate depression (HAMD-17 score: 7-24 points); be diagnosed with the TCM pattern of Kidney Deficiency and Liver Depression according to the "TCM Syndrome Scale for Kidney Deficiency and Liver Depression Pattern"; aged 18-60 years, gender; provide signed informed consent (legal guardians must provide proof of relationship if signing on behalf of the participant).
Exclusion criteria
Exclusion criteria: Pregnant or lactating women; organic brain disorders, psychoactive substance abuse, or comorbid other psychiatric disorders; high suicide risk (Item 3 of HAMD =3 points); known allergy or intolerance to the study drugs (TCM granules or escitalopram); severe hepatic or renal insufficiency (ALT/AST >2 times the upper limit of normal, Cr >1.5 times the upper limit of normal); participation in other clinical trials within the past month.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fatigue Scale-14 (FS-14) Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Hamilton Depression Rating Scale-17 (HAMD-17) Score;TCM Syndrome Scale Score for Kidney Deficiency and Liver Depression Pattern;Hamilton Anxiety Rating Scale (HAMA) Score;Clinical Global Impression - Severity (CGI-S) Score;Personal and Social Performance scale - Chinese Version (PSP-CHN) Score; | — |
Countries
China
Contacts
Public ContactYin Dongqing
Beijing Anding Hospital, Capital Medical University
Outcome results
None listed