The Developmental and Translational Study on Biomarkers and Clinical Characteristics-based Diagnostic and Therapeutic Identification of Major Depressive Disorder: Study Protocol for a Multicenter Randomized Controlled Trial in China

Xiaohua Liu; Yun Wang; Daihui Peng; Huifeng Zhang; Yanqun Zheng; Yan Wu; Yun-Ai Su; Ming Liu; Xiancang Ma; Yi Li; Jianfei Shi; Xiaojing Cheng; Han Rong; Yiru Fang

doi:10.2147/NDT.S271842

The Developmental and Translational Study on Biomarkers and Clinical Characteristics-based Diagnostic and Therapeutic Identification of Major Depressive Disorder: Study Protocol for a Multicenter Randomized Controlled Trial in China

Neuropsychiatr Dis Treat. 2020 Oct 9:16:2343-2351. doi: 10.2147/NDT.S271842. eCollection 2020.

Authors

Xiaohua Liu^#^{1

2}, Yun Wang^#³, Daihui Peng³, Huifeng Zhang^#³, Yanqun Zheng¹, Yan Wu³, Yun-Ai Su⁴, Ming Liu⁵, Xiancang Ma⁶, Yi Li⁷, Jianfei Shi⁸, Xiaojing Cheng⁹, Han Rong¹⁰, Yiru Fang^{2

3

11}

Affiliations

¹ Department of Psychiatry, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, People's Republic of China.
² Shanghai Key Laboratory of Psychotic Disorders, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, People's Republic of China.
³ Division of Mood Disorders, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, People's Republic of China.
⁴ Department of Psychiatry, Peking University Sixth Hospital, Peking, People's Republic of China.
⁵ Department of Psychiatry, Harbin First Specific Hospital, Harbin, People's Republic of China.
⁶ Department of Psychiatry, The First Affiliated Hospital of Xi'an Jiao Tong University, Xi'an, People's Republic of China.
⁷ Department of Psychiatry, Wuhan Mental Health Center, Wuhan, People's Republic of China.
⁸ Department of Psychiatry, Hangzhou Seventh People's Hospital, Hangzhou, People's Republic of China.
⁹ Department of Psychiatry, Shandong Mental Health Center, Shandong, People's Republic of China.
¹⁰ Department of Psychiatry, Shenzhen Kangning Hospital, Shenzhen, People's Republic of China.
¹¹ CAS Center for Excellence in Brain Science and Intelligence Technology, Shanghai, People's Republic of China.

^# Contributed equally.

Abstract

Background: Major depressive disorder (MDD) is a heterogeneous mental disease that encompasses different subtypes and specifiers. Clinically targeted treatments have not been identified yet, although standardized strategies are recommended by several clinical guidelines. The main aim of this study is to respectively identify the precise treatment for three different subtypes of MDD (ie, melancholic, atypical, and anxious).

Methods: An 8-to-12-week, multicenter randomized controlled trial (RCT) with a parallel group design will be conducted to determine the most effective and appropriate treatment. A total of 750 adults diagnosed with MDD will be recruited, categorized into melancholic, atypical or anxious type based on the assessment of the Inventory of Depressive Symptomatology (IDS30) and the Hamilton Anxiety Scale (HAMA), and 1:1 randomly assigned to different intervention groups. Blood draw, EEG test, and MRI scan will be performed at baseline and endpoint. Clinical symptom and side-effects will be evaluated at critical decision points (CDP) including weeks two, four, six, eight, and 12 after treatment. The primary outcome is total score and reduction rate of the 17-Hamilton Depression Rating Scale (17-HDRS). The secondary outcomes include the scores of the Quick Inventory of Depressive Symptomatology-self-report (QIDS-SR), IDS30, HAMA and the Treatment Emergent Symptom Scale (TESS). All the data will be analyzed by SAS software.

Discussion: The study commenced recruitment in August 2017 and is currently ongoing.

Trial registration: ClinicalTrials.gov Identifier: NCT03219008 (July 17, 2017).

Keywords: MDD; RCT; antidepressant; cCBT; computerized cognitive behavioral treatment; major depressive disorder; physical therapy; randomized controlled trial; subtype.

Associated data

ClinicalTrials.gov/NCT03219008

Grants and funding

The work was supported by the National Key Research and Development Program of China (2016YFC1307100, 2016YFC1307102); the National Natural Science Foundation of China (81771465, 81930033); the National Key Technologies R&D Program of China (2012BAI01B04); and the Sanming Project of Medicine in Shenzhen (grant number SZSM201612006). The study was also supported by the Innovative Research Team of High-level Local Universities in Shanghai. The sponsors were not involved in the study design, data collection management, analysis, interpretation of data, writing of the report, or decision to submit the report for publication.