Depression
Conditions
Interventions
Low-Dose Group:Xingpi Jieyu Granules (Low-Dose)
High-Dose Group:Xingpi Jieyu Granules (High-Dose)
Placebo Group:Xingpi Jieyu Granules Placebo
Sponsors
Dongfang Hospital, Beijing University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Meeting the diagnostic criteria for depressive disorder in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5);(2) Meeting the diagnostic criteria for Chinese medicine depressive syndrome and the syndrome criteria for Liver-Spleen Disharmony;(3) Aged 18 to 65 years old (18 = age = 65);(4) At enrollment, the score of the 17-item Hamilton Depression Rating Scale (HAMD-17) is 14 to 23 (14 = HAMD-17 score = 23), with a score of = 2 for Item 1 (Depressed Mood) of the HAMD-17;(5) No antidepressant-related treatment administered 2 weeks prior to enrollment (for Fluoxetine, no administration within 6 weeks);(6) Patients provide informed consent for study participation and sign the informed consent form. Only patients who meet all the above 6 criteria are eligible for enrollment.
Exclusion criteria
Exclusion criteria: (1) Other psychiatric disorders excluded using the Mini International Neuropsychiatric Interview (MINI) for psychiatry, including patients with schizophrenia spectrum and other psychotic disorders, bipolar and related disorders, obsessive-compulsive and related disorders, and other psychiatric disorders;(2) Patients with treatment-resistant depression (TRD) as judged by the investigator or diagnosed previously (those with no response after treatment with two or more antidepressants at an adequate dose for a full course);(3) Patients with a significant suicidal risk as judged by the investigator (a score of = 3 for Item 3 (Suicide) of the HAMD-17), or a history of suicide attempt within the past year; patients with comorbid significant anxiety disorder excluded as judged by the investigator, with a score of = 29 on the Hamilton Anxiety Rating Scale (HAMA);(4) Patients who received non-pharmacological treatments within the past 6 months, including electroconvulsive therapy (ECT), repetitive transcranial magnetic stimulation (rTMS), or more than 10 sessions of structured psychological therapy;(5) Patients with drug dependence or alcohol dependence;(6) Patients with severe heart disease, renal disease, neurological disease, cerebrovascular disease, hepatic disease, hemorrhagic disorders, metabolic diseases, or pulmonary dysfunction;(7) Patients with congenital or acquired mental retardation;(8) Clinically significant abnormalities indicated by a 12-lead electrocardiogram (ECG) that may affect the subject's safety, including but not limited to acute myocardial ischemia, myocardial infarction, severe arrhythmia, or marked QTc prolongation (QTc > 450 ms in males, QTc > 470 ms in females);(9) Patients with abnormal liver or renal function (i.e., aspartate aminotransferase (AST) = 1.5 times the upper limit of normal (ULN), or alanine aminotransferase (ALT) = 1.5 times the ULN, or serum creatinine (Scr) = 1.5 times the ULN);(10) Patients with learning and memory impairment caused by a definite disease;(11) Lactating women, women of childbearing potential, or patients planning to become pregnant;(12) Patients allergic to the components of the study drug;(13) Patients who participated in or are currently participating in other clinical trials within 1 month prior to enrollment;(14) Patients with potential risks or other factors that make them inappropriate for participation in this trial, as judged by the investigator. Any patient who meets any of the above criteria shall be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hamilton Depression Rating Scale Score-17; | — |
Secondary
| Measure | Time frame |
|---|---|
| Hamilton Anxiety Scale Score;Fatigue Self-Rating Scale;Traditional Chinese Medicine syndrome score;Quantitative Grading Scale for Main Symptoms of Liver-Spleen Disharmony Syndrome;Pittsburgh Sleep Quality Index;Patient Health Questionnaire;Clinical Global Impression Scale;Gastrointestinal Symptom Rating Scale;The change values evaluated by comparing the score of the first item (depressed mood) and other main subitems of the 17-item Hamilton Depression Rating Scale with the baseline;Comparison between groups in the 50% reduction score of the 17-item Hamilton Depression Rating Scale;The proportion of participants with a score of 7 or lower on the 17-item Hamilton Depression Rating Scale; | — |
Countries
China
Contacts
Public ContactGuo Rongjuan
Dongfang Hospital of Beijing University of Chinese Medicine
Outcome results
None listed