Depression Disorder
Conditions
Interventions
Intervention Group:Shugan Jieyu Capsule (Sichuan Jishengtang Pharmaceutical Co., Ltd.), Specification: 0.36g/capsule, 2 capsules each time, served both morning and evening
St. John's Wort Extract 0.56g/tablet (Neurostan) Simulator, 1 tablet at a time, 2 times a day.
Control Group:St. John's Wort Extract 0.56g/tablet (Neurostan), 1 tablet at a time, bid po. Shugan Jieyu Capsule Simulator 0.36g/capsule (Sichuan Jishengtang Pharmaceutical Co., Ltd.),2 capsules each
Sponsors
Xuanwu Hospital,Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Diagnosed as depression based on the criteria of Diagnostic Criteria for Mental Disorder(5th Edition)(DSM-5); 2. Hamilton Depression Scale (HAMD-17) score =17 points; 3. Presence with one or more of the following somatization symptoms: including but not limited to: (1) Sleep disorders: chronic insomnia, difficulty falling asleep, early awakening, and more dreams; (2) Tension-type headache; (3) Migraine; (4) Repeated tinnitus; (5) Chronic dizziness; (6) Chronic organic pain without explicit organic damage; (7) Repeated visit to doctors in related departments of general hospitals because of headaches, and pain of neck, back, waist and limbs. Clinical examinations and laboratory examinations suggest no organic damage; (8) nervous, sweating, chest tightness, without organic damage; (9) Eat less, loss of appetite, constipation; (10) Unable to be happy; (11) Have no interest to anything or lose interest in past interests; (12) Hysteresis: slow response (other people say a few sentence while the patient response one), rigidity of thinking, memory decline, forgetful; (13) Chronic pain, dizziness, and fatigue caused by mental factors such as anxiety, terror, suspiciousness, and depression; 4. The patient health questionnaire PHQ-15 = 5 points; 5. Ages 18 to 60 (including 18 and 60 years old), male or female; 6. Signed informed consent.
Exclusion criteria
Exclusion criteria: 1. depression caused by psychoactive drugs; 2. Treatment-refractory depression (have poor clinical efficacy after taking full course of treatment of two or more type of antidepressant with different mechanisms); 3. Presence with depression induced by brain organic diseases (such as intracranial tumors, Parkinson's disease, Alzheimers disease, cerebrovascular accidents, epilepsy, etc.) or brain trauma; 4. Presence with secondary depression induced by hypothyroidism, hypothyroidism and other endocrine disorders caused by; 5. Presence with Schizophrenia, bipolar disorder, somatoform disorder, mania, anorexia, bulimia and other types of mental illness; 6. Presence with strong suicides tendency (HAMD-17 suicide score = 4 points), and teh tendency of hurting others. 7. Have history of substance, alcohol, or drug abuse; 8. Receive mental surgery or electroconvulsive therapy in the past 3 months; 9. Intake of drugs that disturb the therapeutic evaluation of the test drug, drugs that are contraindicated with the test drug, antidepressants within 4 weeks; 10. In patients with severe primary diseases and dysfunctions such as heart, brain, respiratory, digestive, endocrine, hematopoietic, hepatorenal, etc., ALT, AST is more than 2 times the upper limit of normal, or Cr> 130umol/L; 11. Allergic to the known ingredients of the test drug or have serious side effects after taking the test drug, allergic constitution and photosensitivity skin diseases; 12. Pregnancy and breastfeeding women or plan for pregnancy during pregnancy and within 6 months; 13. participated in clinical trials of other drugs in the past three months; 14. Any condition suggested by research that is not suitable to participate in this clinical trial.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| CGI-I;HAMA;CGI-S;PHQ-15;PSQI;Q-LES-Q-SF;TESS;The effective rate of HAMD-17; | — |
Primary
| Measure | Time frame |
|---|---|
| HAMD-17; | — |
Countries
China
Contacts
Public ContactHongxing Wang
Xuanwu Hospital Capital Medical University
Outcome results
None listed