Patients with moderate and severe depression.
Conditions
Interventions
Experimental group: Jieyu Zhufen capsule:Take Jieyu Jieyu capsules
Trial group: Jieyu Jiefeng capsule placebo:Take Jieyu Jiefeng capsule placebo
Sponsors
Second Xiangya Hospital of CSU
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Age: 18-65 years old (including values at both ends); 2.Depression, first attack or recurrence that meets DSM-5 diagnostic criteria; 3.When joining the group, Hamilton Depression Scale (HAMD-17) >= 18 points; 4.Two weeks before joining the group, no antidepressants were used (of which fluoxetine was not used for 6 weeks); 5.Voluntary signing of informed consent;
Exclusion criteria
Exclusion criteria: 1.Meet the diagnostic criteria for DSM-5 other mental disorders other than depression (such as patients with schizophrenia spectrum and other psychotic disorders, biplexic and related disorders, obsessive-compulsive and related disorders); 2.Researchers judge or have been diagnosed with refractory depression in the past (ineffective after sufficient foot treatment of 2 or more antidepressants); 3.The researchers judged that there was a clear risk of suicide (HAMD-17 item 3 (suicide) score >= 3), or those who had a history of suicide attempt in the past year. 4.Those who have received non-pharmacological treatment in the past 6 months, such as electroconvulsive treatment (ECT), repeated transcranial magnetic stimulation treatment (rTMS), and more than 10 system psychotherapy. 5.There are other serious chronic diseases such as severe thyroid disease, Parkinson's disease, tumors, epilepsy, severe rheumatism, etc. 6.12 Lead ECG indicates clinically significant abnormalities that may affect the safety of subjects, including but not limited to acute myocardial ischemia, myocardial infarction, severe arrhythmia or significant QTc prolongation (male QTc>450ms, female QTc>470ms); 7.People with abnormal liver and kidney function (i.e. the upper limit of the normal value of glutanine transaminase (AST) >= 1.5 times or the upper limit of the normal value of alanine transaminase (ALT) >= 1.5 times the normal value, and the upper limit of blood creatinine (Scr) >= 1.5 times the normal value); 8.People who are allergic to experimental drugs or ingredients; 9.Those who are lactating or have pregnancy and those who plan to have a pregnancy; 10.Alcohol and drug addicts; 11.Patients who participated or were participating in other clinical trials within 1 month before joining the group; 12.The researchers believed that the subjects had potential risks or other factors that were not suitable to participate in this experiment;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in the Hamilton Depression Scale (HAMD-17) from baseline at week 8; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical cure rates from baseline on the Hamilton Depression Scale (HAMD-17) at week 8;Response rate of the Hamilton Depression Scale (HAMD-17) compared to baseline at week 8;Changes in the Hamilton Anxiety Scale (HAMA) from baseline at week 8;Changes in the Rapid Self-Rating Scale of Depression Symptoms (QIDS-SR16) from baseline at week 8;Changes in the Anxiety Disorder Screening Scale (GAD-7) from baseline at week 8;Change from baseline in Snath-Hamilton Pleasure Scale (SHAPS) scores at week 8;Changes in the Sheehan Disability Scale (SDS) from baseline at week 8; | — |
Countries
China
Contacts
Public ContactLingjiangLi
Second Xiangya Hospital of CSU
Outcome results
None listed