Subthreshold Depression
Conditions
Interventions
ZHS 02:Dosage and Administration:
Subjects will take oral Zhisuixin Granules No. 2 (each packet contains: FA 100 mg, Angelica Dahurica Extract 30 mg, and PS 15 mg).
Dosage: 2 packets per dose, twice
ZHS 03:Dosage and Administration:
Subjects will take oral Zhisuixin Granules No. 3 (each packet contains: FA 100 mg, Angelica Dahurica Extract 30 mg, and PQQ 2 mg).
Dosage: 2 packets per dose, twice
Sponsors
The Affiliated Brain Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
12 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1 Age: 12 years < Age < 18 years. 2 Diagnosis: Meets the established DSM-5 criteria for subthreshold depression. This is defined as having one core symptom of a depressive episode (loss of interest or depressed mood) and at least one associated symptom (significant unintentional weight loss/gain or decrease/increase in appetite; insomnia or hypersomnia; psychomotor agitation or retardation; fatigue or loss of energy; feelings of worthlessness or excessive/inappropriate guilt; diminished ability to think or concentrate, or indecisiveness). Symptoms must have persisted for at least 2 weeks, but the presentation does not meet the full criteria for major depressive disorder. 3 Symptom Severity: Hamilton Depression Rating Scale 17-item (HAMD-17) score: 8 <= HAMD-17 score <= 16. 4 Treatment Naive: Have not received any antidepressant medication. 5 Consent: Able to comprehend the study procedures and provide written informed consent signed by both the subject and their legal guardian.
Exclusion criteria
Exclusion criteria: 1 Current self-harming behavior, or a history of suicide attempts, or current active suicidal ideation or suicidal behavior (score >2 on the suicide item of the HAMD-17). 2 Currently in a severe phase of illness requiring hospitalization (e.g., active suicidality with intent, severe psychotic features). 3 Diagnosed with neurodevelopmental disorders, depressive disorders (meeting full criteria), bipolar disorder, schizophrenia, severe cognitive impairment, other major psychiatric disorders, or eating disorders. 4 History of alcohol or substance dependence not abstinent for at least the past 6 months. 5 Suffering from severe physical illnesses (e.g., significant cardiac, renal, hepatic, or thyroid diseases). 6 Clinically significant abnormalities in auxiliary examinations or laboratory tests as judged by the investigator. 7 Patients who are lactating or pregnant, or planning to become pregnant during the study period. 8 Known allergy or hypersensitivity to any component of Zhisuixin (oral tablets). 9 Any other condition that, in the investigator's judgment, would make the subject unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HAMD-17;CDI; | — |
Secondary
| Measure | Time frame |
|---|---|
| Cognitive function;HAMA-14;MEI;FAS;PSQI;WHOQOL-BREF; | — |
Countries
China
Contacts
Public ContactYanling Zhou
The Affiliated Brain Hospital of Guangzhou Medical University
Outcome results
None listed