A Study of Individualized Diagnosis and Treatment for Depression with Atypical Features (iDoT-AFD): study protocol for a randomized clinical trial and prognosis study
2023-05-04
发表期刊TRIALS (IF:2.0[JCR-2023],2.1[5-Year])
ISSN1745-6215
EISSN1745-6215
卷号24期号:1
发表状态已发表
DOI10.1186/s13063-023-07317-w
摘要

BackgroundMajor depressive disorder (MDD) with atypical features, namely depression with atypical features (AFD), is one of the most common clinical specifiers of MDD, closely associated with bipolar disorder (BD). However, there is still a lack of clinical guidelines for the diagnosis, treatment, and prognosis of AFD. Our study mainly focuses on three issues about how to identify AFD, what is the appropriate individualized treatment for AFD, and what are the predictive biomarkers of conversion to BD.MethodsThe Study of Individualized Diagnosis and Treatment for Depression with Atypical Features (iDoT-AFD) is a multicenter, prospective, open-label study consisting of a 12-week randomized controlled trial (RCT) and a continued follow-up until 4 years or reaching the study endpoint. It is enrolling 480 patients with AFD (120 per treatment arm), 100 patients with BD, and 100 healthy controls (HC). Multivariate dimension information is collected including clinical features, cognitive function, kynurenine pathway metabolomics, and multimodal magnetic resonance imaging (MRI) data. Firstly, multivariate informatics analyses are performed to recognize patients with AFD from participants including the first-episode and recurrent atypical depression, patients with BD, and patients with HC. Secondly, patients with atypical depression are randomly allocated to one of the four treatment groups including "single application of selective serotonin reuptake inhibitor (SSRI) or serotonin-noradrenaline reuptake inhibitor (SNRI)", "SSRI/SNRI combined with mood stabilizer," "SSRI/SNRI combined with quetiapine (>= 150 mg/day)," or "treatment as usual (TAU)" and then followed up 12 weeks to find out the optimized treatment strategies. Thirdly, patients with atypical depression are followed up until 4 years or switching to BD, to explore the risk factors of conversion from atypical depression to BD and eventually build the risk warning model of conversion to BD.DiscussionThe first enrolment was in August 2019. The iDoT-AFD study explores the clinical and biological markers for the diagnosis, treatment, and prognosis of AFD and further provides evidence for clinical guidelines of AFD.

关键词Major depressive disorder Atypical features Individualized diagnosis and treatment Predictive biomarkers of conversion to bipolar disorder
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收录类别SCI
语种英语
资助项目Key Clinical Research Program of Shanghai Mental Health Center[CRC2018ZD05] ; Cross-Disciplinary and Translational Medical Research of Shanghai Jiao Tong University[ZH2018ZDA29]
WOS研究方向Research & Experimental Medicine
WOS类目Medicine, Research & Experimental
WOS记录号WOS:000981586200002
出版者BMC
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文献类型期刊论文
条目标识符https://kms.shanghaitech.edu.cn/handle/2MSLDSTB/305015
专题生物医学工程学院
生物医学工程学院_PI研究组_王乾组
通讯作者Peng, Daihui
作者单位
1.Shanghai Jiao Tong Univ, Shanghai Mental Hlth Ctr, Sch Med, Div Mood Disorders, 600 South Wan Ping Rd, Shanghai 200030, Peoples R China
2.Wuhan Mental Hlth Ctr, Wuhan, Hubei, Peoples R China
3.Guangzhou Med Univ, Guangzhou Brain Hosp, Affiliated Hosp, Dept Affect Disorders, Guangzhou, Peoples R China
4.Dalian Seventh Peoples Hosp, Dalian, Liaoning, Peoples R China
5.Fourth Mil Med Univ, Xijing Hosp, Dept Psychiat, Xian, Shaanxi, Peoples R China
6.ShanghaiTech Univ, Sch Biomed Engn, Shanghai, Peoples R China
7.Jianghan Univ, Wuhan, Hubei, Peoples R China
8.Shanghai Jiao Tong Univ, Med X Res Inst, Sch Biomed Engn, Shanghai, Peoples R China
推荐引用方式
GB/T 7714
Zhou, Rubai,Zhang, Huifeng,He, Shen,et al. A Study of Individualized Diagnosis and Treatment for Depression with Atypical Features (iDoT-AFD): study protocol for a randomized clinical trial and prognosis study[J]. TRIALS,2023,24(1).
APA Zhou, Rubai.,Zhang, Huifeng.,He, Shen.,Li, Yi.,Xu, Guiyun.,...&Peng, Daihui.(2023).A Study of Individualized Diagnosis and Treatment for Depression with Atypical Features (iDoT-AFD): study protocol for a randomized clinical trial and prognosis study.TRIALS,24(1).
MLA Zhou, Rubai,et al."A Study of Individualized Diagnosis and Treatment for Depression with Atypical Features (iDoT-AFD): study protocol for a randomized clinical trial and prognosis study".TRIALS 24.1(2023).
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