Adolescent Depression
Conditions
Interventions
Study group:Standardized psychological counseling (same as control group) plus Sini Powder combined with Xiaoxianxiong Decoction, once daily for 8 weeks
Control group:Standardized psychological counseling including cognitive behavioral intervention (45 min/session) and family support guidance (30 min/session), once a week for 8 weeks.
Sponsors
The Third Hospital of Mianyang, Mianyang, Sichuan Province, China
Eligibility
Sex/Gender
All
Age
12 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1) Meet the diagnostic criteria for depression in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5)(Guha M et al, 2014); 2) TCM syndrome differentiation conforms to the syndrome of liver qi stagnation transforming into heat and phlegm-heat stagnation in the chest, with main symptoms including low mood, irritability and easy anger, chest tightness and stuffiness; secondary symptoms including bitter mouth and dry throat, poor appetite, insomnia and dreaminess, red tongue with yellow and greasy coating, stringy and rapid pulse(Ye W et al, 2025); Clinical Application Guidelines for Chinese Patent Medicines in the Treatment of Depressive Disorder (Standardization Project Team of *Guidelines for Clinical Application of Chinese Patent Medicines in the Treatment of Dominant Diseases*, 2023)3) Aged 12-18 years; 4) CDRS-R score =20 points at baseline (indicating moderate depressive severity); 5) No use of antidepressant drugs, TCM decoctions, or other mental intervention measures in the past 1 month; 6) Voluntarily participate in the study and cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1) Complicated with other mental diseases such as schizophrenia, bipolar affective disorder, and autism spectrum disorder; 2) Complicated with severe liver, kidney, heart, or other organ dysfunction; 3) Complicated with immune system diseases, endocrine diseases, or malignant tumors; 4) Allergic to the Chinese medicinal materials used in the study; 5) Poor compliance, unable to complete the intervention course or follow-up; 6) With a history of drug abuse or alcoholism.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Children's Depression Rating Scale-Revised (CDRS-R) score;TCM syndrome score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pediatric Quality of Life Inventory (PedsQL) score;Clinical effective rate ;Adverse events; | — |
Countries
China
Contacts
Public ContactRuiyu Lin
The Third Hospital of Mianyang, Mianyang, Sichuan Province, China
Outcome results
None listed