Major Depressive Disorder
Conditions
Interventions
Intervention Group 2:Sini SAN traditional decoction + formula particle simulator
Intervention Group 1C:Sini SAN formula granule high dose + traditional decoction simulator
Intervention Group 1B:Sini SAN formulation granule medium dose + traditional decoction simulator
Placebo group:Sini SAN formula granule simulator + traditional decoction simulator
Intervention Group 1A:Sini SAN formula granule low dose + traditional decoction simulator
Sponsors
Guangdong Provincial Hospital of Chinese Medicine
Eligibility
Sex/Gender
All
Age
10 Years to 19 Years
Inclusion criteria
Inclusion criteria: 1. Meet the DSM-V major depressive disorder ICD-11 mild to moderate depressive episode diagnostic criteria; The diagnosis of depression subtypes (including anxiety with pain mixed features depressive features atypical features and catatonic disorder) was consistent with the annotated entries in DSM-V major depressive disorder; 2. TCM syndrome type diagnosis in line with the "Classification and code of TCM diseases" and "TCM Clinical Diagnosis and treatment Terms" (revised by the State Administration of Traditional Chinese Medicine) "liver stagnation and spleen deficiency" syndrome. 3. Adolescents with first episode of depression who did not take any antidepressant drugs; 4. Aged between 10 and 19.
Exclusion criteria
Exclusion criteria: 1. Meet the ICD-11 diagnostic criteria for a major depressive episode with a current suicide plan or history of suicidal behavior. Alternatively score =20 on the Patient Health Questionnaire (PHQ-9) >18 on the Hamilton Depression Rating Scale (HAMD) =9 on the Suicide Risk Assessment Scale (NGASR) or =15 on the Generalized Anxiety Disorder scale (GAD-7); 2. Have a previous or concurrent history of psychiatric symptoms mental disorders or other mood disorders; 3. Have a history of or concurrent brain trauma or brain diseases; 4. Have primary diseases affecting the cardiovascular pulmonary hepatic renal or hematopoietic systems or other significant physical illnesses; 5. Exhibit abnormal results in routine laboratory tests (urinalysis liver function tests complete blood count); 6. Pregnant or lactating; 7. Have had an infection with fever within one week prior to enrollment; 8. Have participated in other clinical trials within the past three months; 9. Weigh less than 30 kg.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient Health Questionnaire-9(PHQ-9);Hamilton depression rating scale(HAMD); | — |
Secondary
| Measure | Time frame |
|---|---|
| Conell Medical Index(CMI);Hamilton anxiety rating scale(HAMA);fucntional magnetic resonance imaging(fMRI);Generalized anxiety disorder-7(GAD-7);Pittsburgh sleep quality index(PSQI); | — |
Countries
China
Contacts
Public ContactYang Lingling
Guangdong Provincial Hospital of Chinese Medicine
Outcome results
None listed