Anxiety Depression
Conditions
Interventions
Experimental group:Trazodone+Jiuwei Zhenxin Granules
Control group:Trazodone+Jiuwei Zhenxin Granules Simulant
Sponsors
Henan Provincial Psychiatric Hospital
Eligibility
Sex/Gender
All
Age
13 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1.Meet the dual diagnostic criteria of TCM syndrome differentiation and Western medicine disease differentiation; (1)Patients who met criteria F41.2 for mixed anxiety and depression disorder in ICD-10 and were diagnosed with anxiety depression. This mixed category should be used when both anxiety and depression disorders are present, but neither group of symptoms is sufficient to qualify for a diagnosis when considered separately. Some autonomic symptoms (tremors, palpitations, dry mouth, stomach agitation) must be present, even intermittently. The DSM-5 defines anxiety depression as the presence of at least 2 of the following symptoms that persist for more than 2 weeks on most days of a depressive episode or persistent depressive disorder (dysthymia), including: ? feeling agitated or nervous; ? feeling unusually restless; ? difficulty concentrating due to worry; ? Fear that something terrible might happen; ? You may feel out of control. (2)Standards of syndrome differentiation in Traditional Chinese Medicine: The syndrome of deficiency of both heart and spleen must has the main symptom ? as well as one other symptom and three minor symptoms, and it can be diagnosed base on tongue and pulse. Syndrome of deficiency of both heart and spleen: main symptoms: ?thoughtfulness, worry and confusedness; ?Insomnia and dreamful sleep; ?Palpitation. Minor symptoms: ? Loss of appetite; ?physically and mentally fatigue; ? Dizziness; ?Sweat easily;? Frequent sigh; ?Sallow complexion. Tongue and pulse: ? Pale tongue with thin and white coating;?Thin pulse string or deep thready pulse. 2.The patient who is an 13-18 years old male and female; 3.Subject and legal guardian who sign the Informed Consent Form.
Exclusion criteria
Exclusion criteria: 1.The patient who suffers from serious cardiac, hepatic and renal diseases, hyperthyroidism or serious organic diseases; 2.The Patient with history of severe allergy or hypersensitivity reaction, allergic to Jiuwei Zhenxin granules or trazodone; 3.A patient with other mental disorders accompanied by anxiety disorders, such as depression disorders, phobic anxiety disorders, panic disorders, obsessive-compulsive disorders, schizophrenia, and bipolar affective disorders; 4.A patient with ALT and AST values were greater than normal values; 5.Leukopenia; (Clinically significant leukopenia); 6.Tne patient who have participated in other clinical trials within 30 days; 7.The Patient with a serious risk of suicide, defined as a HAMD-D3 score of 5; 8.A patient with liver-yang hyperactivity (red tongue with yellow coating) from the perspective of Chinese medicine; 9.Other conditions that the investigator deemed inappropriate for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HAMA total score;Factor scores of HAMA;Grading of efficacy of HAMA; | — |
Secondary
| Measure | Time frame |
|---|---|
| HAMD total score;Factor scores of HAMD;Grading of efficacy of HAMD;Beck Anxiety Inventory(BAI));Beck Depression Inventory(BDI);Clinical Global Impression(CGI); | — |
Countries
China
Contacts
Public ContactChanghong Wang
Henan Provincial Psychiatric Hospital
Outcome results
None listed