Sequenced treatment alternatives to relieve adolescent depression (STAR-AD): a multicentre open-label randomized controlled trial protocol

作者全名："He, Yuqian; Gan, Xieyu; Li, Xuemei; Wang, Ting; Li, Jie; Lei, Tingting; Huang, Yajie; Liu, Ruibing; Chen, Fei; Teng, Teng; Xie, Yuxin; Ouyang, Xuan; Zhou, Xinyu"

作者地址："[He, Yuqian; Li, Xuemei; Li, Jie; Lei, Tingting; Huang, Yajie; Liu, Ruibing; Chen, Fei; Teng, Teng; Zhou, Xinyu] Chongqing Med Univ, Dept Psychiat, Affiliated Hosp 1, 1 Youyi Rd, Chongqing 400016, Peoples R China; [Gan, Xieyu] Chongqing Med Univ, Dept Neurol, Affiliated Hosp 2, Chongqing, Peoples R China; [Wang, Ting] Chongqing Med Univ, Dept Psychol, Affiliated Hosp 2, Chongqing, Peoples R China; [Xie, Yuxin; Ouyang, Xuan] Cent South Univ, Xiangya Hosp 2, Natl Clin Res Ctr Mental Disorders, Dept Psychiat, Changsha, Peoples R China; [Xie, Yuxin; Ouyang, Xuan] Cent South Univ, Natl Ctr Mental Disorders, Dept Psychiat, Xiangya Hosp 2, Changsha, Peoples R China"

通信作者："Zhou, XY (通讯作者)，Chongqing Med Univ, Dept Psychiat, Affiliated Hosp 1, 1 Youyi Rd, Chongqing 400016, Peoples R China.; Ouyang, X (通讯作者)，Cent South Univ, Xiangya Hosp 2, Natl Clin Res Ctr Mental Disorders, Dept Psychiat, Changsha, Peoples R China.; Ouyang, X (通讯作者)，Cent South Univ, Natl Ctr Mental Disorders, Dept Psychiat, Xiangya Hosp 2, Changsha, Peoples R China."

来源：BMC PSYCHIATRY

ESI学科分类：PSYCHIATRY/PSYCHOLOGY

WOS号：WOS:001091899200003

JCR分区：Q2

影响因子：3.4

年份：2023

卷号：23

期号：1

开始页：　

结束页：　

文献类型：Article

关键词：　

摘要："BackgroundAdolescent major depressive disorder (MDD) is a prevalent mental health problem with low treatment success rates. Whether fluoxetine or fluoxetine combined with cognitive-behavioural therapy (CBT) is the more effective initial treatment for adolescent MDD remains controversial, and few studies have investigated whether treatment switching or augmentation is preferred when the initial treatment is not working well.MethodsWe developed a multicentre open-label Sequential Multiple Assignment Randomized Trial (SMART) design, consisting of two phases lasting 8 weeks each. In phase 1 (at baseline), patients will be recruited and grouped in fluoxetine group or fluoxetine combined with CBT group by patient self-selection. In phase 2 (after 8 weeks of treatment), the nonresponders will be randomly assigned to six groups, in which participants will switch to sertraline, vortioxetine, or duloxetine or added aripiprazole, olanzapine, or lithium carbonate to fluoxetine. After the full 16 weeks of treatment, we will assess the long-term sustainability of the treatment effects by evaluating participants during their subsequent naturalistic treatment. The primary outcome will be the response rate, determined by the Children's Depression Rating Scale-Revised (CDRS-R). Secondary outcomes include the change in scores on the Beck Depression Inventory (BDI), the Screen for Child Anxiety-Related Emotional Disorders (SCARED) and the Safe Assessment.DiscussionThe results from this study will aid clinicians in making informed treatment selection decisions for adolescents with MDD.Trial registrationThis protocol was registered at ClinicalTrials.gov with Identifier: NCT05814640."

基金机构：None.

基金资助正文：None.