优化青少年重度抑郁症的治疗:皮内针刺的影响——一项随机对照试验方案
Optimizing Treatment for Major Depressive Disorder in Adolescents: The Impact of Intradermal Acupuncture - A Randomized Controlled Trial Protocol.
作者信息
Chen Nisang, Wu Xiaoting, Tu Mingqi, Xiong Sangsang, Jin Junyan, Qu Siying, Pei Shuangyi, Fang Jianqiao, Shao Xiaomei
机构信息
Key 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.
Key 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.
出版信息
Neuropsychiatr Dis Treat. 2023 Aug 23;19:1819-1832. doi: 10.2147/NDT.S420489. eCollection 2023.
BACKGROUND
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: NCT05832619 (April 27, 2023).
背景
重度抑郁症(MDD)在青少年中发病率显著,与成年人中观察到的16.6%的终生患病率相近。其治疗困难且易于复发。针灸已显示出提高治疗效果的潜力。然而,关于皮内针(IA)治疗青少年MDD的研究尚少。
方法
本研究为双盲随机对照试验。120名参与者将被随机分配到三个不同的组,即仅使用选择性5-羟色胺再摄取抑制剂(SSRIs)组、假皮内针联合SSRIs(SIA)组和真皮内针联合SSRIs(AIA)组。汉密尔顿抑郁量表将作为主要结局指标,而患者健康问卷-9、自评抑郁量表、匹兹堡睡眠质量指数和简明健康状况调查问卷将作为评估患者抑郁症状改善情况的次要结局指标。这些数据将使用SPSS26.0软件进行分析。
结果
我们将使用常用的临床精神科量表评估皮内针对MDD的疗效和安全性。
结论
本研究可能会证明皮内针治疗青少年MDD的疗效,表明其在优化MDD治疗方案方面的潜力。
试验注册
ClinicalTrials.gov标识符:NCT05832619(2023年4月27日)。