Optimizing Treatment for Major Depressive Disorder in Adolescents: The Impact of Intradermal Acupuncture - A Randomized Controlled Trial Protocol

Abstract

Nisang Chen,1,* Xiaoting Wu,1,* Mingqi Tu,1 Sangsang Xiong,1 Junyan Jin,1 Siying Qu,1 Shuangyi Pei,1,2 Jianqiao Fang,1,2 Xiaomei Shao1,2 1Key Laboratory of Acupuncture and Neurology of Zhejiang Province, Department of Neurobiology and Acupuncture Research, The Third Clinical Medical College, Zhejiang Chinese Medical University, Hangzhou, People’s Republic of China; 2Key Laboratory for Research of Acupuncture Treatment and Transformation of Emotional Diseases, The Third Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, People’s Republic of China*These authors contributed equally to this workCorrespondence: Xiaomei Shao; Jianqiao Fang, Zhejiang Chinese Medical University, No. 548, Binwen Road, Binjiang District, Hangzhou City, Zhejiang Province, People’s Republic of China, Email [email protected]; [email protected]; [email protected]: Major depressive disorder (MDD) exhibits a pronounced occurrence among adolescents, aligning closely with the lifetime prevalence rate of 16.6% observed in adults. It is difficult to treat and prone to recurrence. Acupuncture has shown potential in enhancing treatment effectiveness. Nonetheless, there is a lack of research on the use of intradermal acupuncture (IA) in treating adolescent MDD.Methods: This study is a double-blind, randomized controlled trial. A cohort of 120 participants will be assigned randomly to three distinct groups, namely a Selective Serotonin Reuptake Inhibitors (SSRIs)-only group, a sham intradermal acupuncture combined with SSRIs (SIA) group, and an active intradermal acupuncture combined with SSRIs (AIA) group. Hamilton Depression Rating Scale will serve as the primary outcome, while Patient Health Questionnaire-9, Self-Rating Depression Scale, Pittsburgh Sleep Quality Index, and Short Form 36 Questionnaire will serve as secondary outcomes in assessing the amelioration of depressive symptoms in patients. These data will be analyzed using SPSS26.0 software.Results: We will assess the efficacy and safety of IA for MDD using commonly employed clinical psychiatric scales.Conclusion: The efficacy of IA in treating adolescent MDD may be demonstrated in this study, suggesting its potential for optimizing MDD treatment schemes.Trial Registration: ClinicalTrials.gov Identifier: NCT 05832619 (April 27, 2023).Keywords: major depressive disorder, intradermal acupuncture, selective serotonin reuptake inhibitors, adolescent, randomized controlled trial, protocol

Keywords

• major depressive disorder
• intradermal acupuncture
• selective serotonin reuptake inhibitors
• adolescent
• randomized controlled trial
• protocol