Clinical study of acupuncture in the treatment of depressive disorders in adolescents

Early Phase 1

Conditions: depression

Registration Number: ITMCTR2024000186

Lead Sponsor: The Affiliated TCM Hospital of Guangzhou Medical University

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1) 12 years<=Age<18 years;
2) Meet DSM-5 diagnostic criteria for depressive disorders;
3) Meet mild (8 = 17-item Hamilton Depression Rating Scale score <14) and moderate (14 = 17-item Hamilton Depression Rating Scale score <20);
4) No suicide risk, a no response on all items of the Suicide Severity Rating Scale (C-SSRS), and a score of <3 on item 3 (suicide) of the HAMD-17;
5) Have not been treated with antidepressants (escitalopram, mirtazapine, etc.) and physical therapy (acupuncture, transcranial magnetic stimulation, transcranial electrical stimulation, electroconvulsive therapy, etc.) within the previous 1 month;
6) The study subjects and their guardians refused to take the medication;
7) Reads and writes properly and is able to communicate properly;
8) The study subjects and their guardians volunteered to participate in this study and signed an informed consent form.

Exclusion Criteria

1) Currently or previously suffered from a diagnosis consistent with other mental disorders in the DSM-5, such as bipolar disorder, schizophrenia, post-traumatic stress disorder, and personality disorders;
2) Patients with severe or unstable cardiovascular, respiratory, hepatic, renal, hematologic, or other systemic diseases, as well as patients with acute illnesses, infectious diseases, or malignant tumors, who, in the opinion of the investigator, are not suitable for enrollment in this stud;
3) Presence of a history of psychoactive substance (e.g., alcohol, drugs, etc.) abuse or dependence.

Study & Design

Study Type: Interventional study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference in Children's Depression Rating Scale - Revised (CDRS-R) scores;

Secondary Outcome Measures

Name	Time	Method
PSQI scale score difference;Difference in Children's Depression Rating Scale - Revised (CDRS-R) scores;Clinical remission rate(HAMD-17 score <7 after 8 weeks of treatment);C-SSRS scale score difference;HAMD-17 clinical reduction rate( = pre-treatment HAMD-17 score - post-treatment HAMD-17 score)/Pre-treatment HAMD-17 score;HAMA-14 scale score difference;HAMD-17 scale score difference;