Effect of XingpiJieyu Formula on Mitochondrial Energy Metabolism in Severe Liver-Stagnation and Spleen-Deficiency Depression.

Study Title: Research on the therapeutic effect and clinical indicators of XingpiJieyu formula in the treatment of severe liver depression and spleen deficiency type depression based on abnormal mitochondrial energy metabolism pathway Purpose of the Study: (1) Application of XPJYF in the treatment of severe MDD patients for 8 weeks, detection of abnormal mitochondrial energy metabolism and biosynthesis, and exploration of biological markers for the therapeutic effect of XPJYF in the treatment of severe MDD with liver depression and spleen deficiency type. (2) Explore the biological indicators for predicting the antidepressant efficacy of XPJYF in the treatment of severe MDD patients and explore new pharmacological pathways for the combination of traditional Chinese and Western medicine in the treatment of MDD. To evaluate whether adding Xingpi Jieyu Formula (a traditional Chinese herbal granule) to the standard antidepressant escitalopram improves symptoms in people with severe major depressive disorder (MDD) who also have a specific traditional Chinese medicine pattern called "Liver-Stagnation and Spleen-Deficiency." Study Design: 100 patients with severe MDD (Liver-Stagnation and Spleen-Deficiency pattern) will be randomly assigned to one of two groups: Test group: Escitalopram + Xingpi Jieyu Formula, Control group: Escitalopram + placebo (identical granules with no active ingredient). An additional 50 healthy volunteers will serve as a comparison group. Treatment duration: 8 weeks. Double-blind design: neither participants nor study doctors know who receives the real herbal formula or the placebo. Data Collection Timepoints: Baseline (before treatment), Week 2, and Week 8 (end of treatment). At each timepoint, blood samples and clinical information (e.g., mood ratings, symptom scores) will be collected. Main Measurements: Blood samples will be tested for markers of mitochondrial energy metabolism (using ELISA). Whole genome testing will be performed in 60