Psychological Dysfunction (Depression)
Conditions
Interventions
Intervention Group:Modified Sini Powder Granules
Sponsors
Sichuan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) No restriction on gender; age between 18 and 80 years; 2) Diagnosis of depression based on the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-5) confirmed by a licensed psychiatrist at each center; 3) Moderate to severe depression defined as a HAMD-17 score =17; 4) Pathologically confirmed non-small cell lung cancer (NSCLC) clinical stage I–III according to the 8th edition of the American Joint Committee on Cancer (AJCC) staging system; 5) Underwent radical resection for lung cancer with the time since surgery not exceeding 6 months; 6) Estimated survival time =6 months; 7) Karnofsky Performance Status (KPS) score =70; 8) No prior use of antidepressant medications.
Exclusion criteria
Exclusion criteria: 1) Pregnant or lactating women; 2) Meeting diagnostic criteria for other psychiatric disorders according to DSM-5 including but not limited to generalized anxiety disorder schizophrenia bipolar disorder etc.; 3) Current presence of severe suicidal ideation or history of suicide attempt; 4) History of existing or past organic brain disorders; 5) Presence of serious physical illnesses requiring treatment; 6) Abnormal results in routine blood tests or liver/kidney function tests that fall outside the laboratory reference range; 7) Use of antibiotics or probiotics within the past 12 weeks (which may interfere with gut microbiota analysis); 8) Currently receiving or expected to receive postoperative oncologic treatments during the study period including but not limited to radiotherapy chemotherapy immunotherapy or targeted therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 17 items of the Hamilton Depression Scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival and Overall Survival;7-tiem Generalized Anxiety Disorder Scale;Serum Untargeted Metabolomics;Pittsburgh Sleep Quality Index;Fear of Cancer Recurrence Inventory;Serum Brain-Derived Neurotrophic Factor;Serum Neurotransmitters;Serum Hypothalamic-Pituitary-Adrenal (HPA) Axis–Related Hormones;Serum Inflammatory Cytokines;Functional Assessment of Cancer Therapy-Lung;Patient Health Questionnaire-9;Gut Microbiota; | — |
Countries
China
Contacts
Public ContactZuyi Yang
Department of Traditional Chinese Medicine Sichuan Cancer Hospital
Outcome results
None listed