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Multimodal Identification of Dynamic Changes in Traditional Chinese Medicine Syndromes in Adolescent Depression

Multimodal Identification of Dynamic Changes in Traditional Chinese Medicine Syndromes in Adolescent Depression

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000707
Enrollment
Unknown
Registered
2026-03-24
Start date
2026-04-01
Completion date
Unknown
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adolescent Depression

Interventions

Liver Qi Stagnation Syndrome Group of aMDD:Traditional Chinese medicine preparation: Chaihu Shugan Wan
Heart-spleen deficiency syndrome Group of aMDD:Traditional Chinese Medicine preparation: Ginseng Gui Pi Pills

Sponsors

Institute of Basic Research in Clinical MedicineChina Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
12 Years to 18 Years

Inclusion criteria

Inclusion criteria: aMDD Group Inclusion Criteria: 1) Age 12–18 years; 2) Meets DSM-5-TR criteria for Major Depressive Disorder (MDD); 3) Episode severity rated as mild or moderate; 4) Hamilton Depression Rating Scale (HAM-D) score >17 (mild: 8–16 points; moderate depression: 17–23 points); 5) Meets TCM diagnostic criteria for Liver Qi Stagnation Pattern or Heart-Spleen Deficiency Pattern; 6) No antidepressant or other psychiatric medication use within 2 months prior to enrollment, or discontinuation for =2 months; 7) Voluntary participation by the subject with informed consent signed by a legal guardian. Healthy Control Group Inclusion Criteria: 1) Meets criteria for the "Harmonious Constitution" classification in the "Classification and Determination of Traditional Chinese Medicine Constitutions," with a conversion score =60 on the "Traditional Chinese Medicine Constitution Classification and Determination Table," and conversion scores for all other 8 constitutions <30; 2) Does not meet diagnostic criteria for any depressive disorder, bipolar disorder, psychotic disorder, or other mental disorders in DSM-5-TR; 3) No past or current history of mental disorders such as depression or anxiety; no first-degree relatives with a history of major mental disorders (e.g., schizophrenia, bipolar disorder); 4) HAM-A < 7, HAM-D < 7; 5) Matched with aMDD group subjects in terms of gender, age, and educational level; 6) No use of any antidepressants, antipsychotics, or centrally acting medications within the past 2 months; 7) Subjects voluntarily participate, with informed consent signed by legal guardians.

Exclusion criteria

Exclusion criteria: aMDD Group Exclusion Criteria: 1) Organic brain disease. 2) Depression associated with medically induced or substance-induced depressive symptoms. 3) Seasonal depressive pattern as defined by DSM-5-TR. 4) Bipolar disorder, psychotic disorders, personality disorders, pervasive developmental disorders, autism spectrum disorders, obsessive-compulsive disorder, post-traumatic stress disorder, attention-deficit/hyperactivity disorder, or eating disorders and other psychiatric disorders. 5) History of bipolar I/II disorder in first-degree relatives. 6) Suicide risk indicated by explicit intent and plans and/or prior suicide attempts. 7) History of neurological disorders, seizures, substance abuse, or alcohol dependence within the past year. 8) Severe cardiac, hepatic, renal, or hematologic diseases; uncontrolled hyperthyroidism or hypothyroidism. Healthy control group exclusion criteria: 1) Past or current clinical diagnosis of any psychiatric disorder, including depression, anxiety, bipolar disorder, schizophrenia, obsessive-compulsive disorder, or attention deficit hyperactivity disorder. 2) Organic brain disorders (e.g., traumatic brain injury, brain tumor, intracranial infection, cerebrovascular disease). 3) Severe cardiac, hepatic, renal, or hematologic diseases; uncontrolled hyperthyroidism or hypothyroidism. 4) History of neurological disorders, epileptic seizures, psychoactive substance abuse, or alcohol dependence within the past year.

Design outcomes

Primary

MeasureTime frame
Hamilton Depression Scale(HAMD);

Secondary

MeasureTime frame
Traditional Chinese medicine Syndrome Score;Electroencephalogram(EEG) behavioral data;Electroencephalogram(EEG) data;

Countries

China

Contacts

Public ContactRui Xu

Institute of Basic Research in Clinical MedicineChina Academy of Chinese Medical Sciences

anxietypsy@163.com15300275523

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Apr 4, 2026