Depressed
Conditions
Interventions
Control group:SSRI-type antidepressants alone
Trial group:SSRI antidepressants + Xuhanting Granules
Sponsors
The Third Affiliated Hospital of Sun Yat-Sen University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. A male or female outpatient or inpatient aged 18-65; 2. Meet the diagnostic criteria for single episode or recurrent monophasic depressive disorder without psychotic symptoms as assessed by DSM-IV-TR clinical evaluation. This diagnostic conclusion needs to be confirmed through structural diagnostic interviews using the Concise International Neuropsychiatric Interview (MINI) depression module and mental and emotional disorders (with psychiatric characteristics module); 3.Women who are fertile must agree to use medically approved contraceptive methods or avoid sexual activity during the study period and within one month after the last study drug administration; 4. The investigator's judgment is reliable and has sufficient understanding ability to conduct all tests or inspections required by the trial protocol, understand the nature of the study, and sign an informed consent form; 5. The total score of the 17 Hamilton Depression Scale (HAMD-17) is >= 22; 6. No unstable serious physical diseases.
Exclusion criteria
Exclusion criteria: 1. Diagnosis of Parkinson's disease or related diseases; 2.According to the DSM-IV-TR standard, any of the following diseases have been diagnosed currently or in one's lifetime: schizophrenia, schizophrenic like mental disorder, affective schizophrenic mental disorder, delusional mental disorder, unspecified mental disorder, type I or II bipolar disorder, any type of delirium, any type of dementia Any mental disorder caused by systemic physical illness (unless there is clear evidence that the patient has been misdiagnosed); 3.According to the DSM-IV-T standard, the current diagnosis is postpartum depression or seasonal depressive disorder; 4.According to DSM-IV-TR criteria, there are paranoid, schizophrenic, schizophrenic, antisocial, or borderline personality disorders (second axis) as a comorbidity or primary diagnosis; 5. According to clinical judgment, the MINI results completed at visit 1 indicate that there are psychotic symptoms within one month of the visit; 6. Substance dependence/abuse (excluding nicotine or caffeine dependence); 7. The researcher judges that there is a strong or active concept of suicide; 8. Pregnant or lactating women; 9. Suffering from acute angle closure glaucoma; 10. Have a history of allergy to SSRI antidepressants or Xu Hanting in the past; 11. Has received electroconvulsive therapy (MECT) during this depressive episode, or has a history of failure in MECT therapy after a sufficient course of treatment; 12. If the patient receives psychotherapy or phototherapy, and requests a change in the frequency, intensity, or termination of the treatment plan during the course of the study. Note: Patients who did not receive any of these treatments when entering the study cannot begin any of these treatments during the study period; 13. Received monoamine oxidase inhibitor (MAIO) treatment within 1 month before participating in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Montgomery-AsbergDepressionRatingScale; | — |
Secondary
| Measure | Time frame |
|---|---|
| Health Survey Short Form;Sheehan Disability Scale; | — |
Countries
China
Contacts
Public ContactNianhong Guan
The Third Affiliated Hospital of Sun Yat-Sen University
Outcome results
None listed