Construction of multimodal prediction system and traditional Chinese medicine intervention for adolescent depression based on the original syndrome differentiation theory of traditional Chinese medicine

Early Phase 1

Conditions: depressive disorder
depression

Registration Number: ITMCTR2024000162

Lead Sponsor: Affiliated Hospital of Shandong University of Traditional Chinese Medicine

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

(1) meet the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5) Major Depressive disorder (MDD) Disorder), referring to depression and anxiety disorder in TCM Treatment of Mental and Behavioral DiseasesInterpretation of will and Mind Syndrome Differentiation (2008) and depression disease in TCM Diagnostic Efficacy Criteria of Diseases and Syndromes (2012), formulated the TCM diagnostic criteria of insufficient spirit, depression of mind and soul.
(2) The total score of the first 17 items of the 24 items of the Hamilton Depression Scale (HAMD) was =8 and =24;
(3) age 12-18 years old, both sexes;
(4) patients who were willing to be tested and signed informed consent;
(5) had not taken antidepressant or anti-anxiety drugs in the past, or had taken but stopped the drugs for more than 1 month, beyond the drug washout period;

Exclusion Criteria

(1) patients with severe heart, liver or kidney dysfunction or complicated with other serious underlying diseases;
(2) female patients during pregnancy or lactation;
(3) patients with bipolar disorder and other psychotic disorders;
(4) patients with previous allergies to the drugs used in the trial;
(5) patients with long-term use of other psychotropic drugs.

Study & Design

Study Type: Interventional study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hamilton Depression Scale, HAMD-24;

Secondary Outcome Measures

Name	Time	Method
blood routine examination;Nurses' Global Assessment of Suicide Risk scale;Non-Suicidal Self-Injury questionnaire;TCM syndrome quantitative table score;Somatic Selfrating Scale;liver function test;