The National Clinical Research Center for Mental Disorders & Beijing Key Laboratory of Mental Disorders & Beijing Anding Hospital, Capital Medical University, 5 Ankang Lane, Dewai Avenue, Xicheng District, Beijing, 100088, China.
Advanced Innovation Center for Human Brain Protection, Capital Medical University, Beijing, China.
Trials. 2022 May 3;23(1):367. doi: 10.1186/s13063-022-06295-9.
Despite the recent findings presenting the benefits of measurement-based care (MBC) compared to treatment as usual (TAU), MBC is still not the standard of care used in clinical settings. The aim of the present study was to achieve the optimization of MBC (OMBC) for major depressive disorder (MDD) by establishing a comprehensive MBC framework based on all-round, continuous assessment for depression.
The target recruitment size is 900 patients, and the study is conducted at 8 centers in China. The patients are randomly assigned to the MBC and TAU groups at a 2:1 ratio. The subjects are scheduled to remain for 12 weeks in the acute phase and for 12 months in the maintenance phase. The primary outcomes are the complete remission rate and the proportion of patients with a 16-item Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR 16) total score ≤ 5 of the MBC and TAU groups at the acute phase, and the recurrence rate/time between the two groups is measured at the maintenance phase. Secondary outcomes included the changes in the parameters QIDS-SR 16, Patient Health Questionnaire-9 (PHQ-9), and 17-item Hamilton Rating Scale for Depression (HAMD-17) from baseline and the response rate between the two groups at the acute phase as well as the comparison of recurrence rate between the two groups at the end of the study.
Chinese Clinical Trial Registry, ChiCTR-OOC-17012566 . The registration was performed retrospectively on 4 September 2017.
尽管最近的研究结果表明基于测量的治疗（MBC）优于常规治疗（TAU），但 MBC 仍未成为临床实践中的常规治疗标准。本研究旨在通过建立一个全面的、持续的抑郁评估 MBC 框架来实现 MBC 的优化（OMBC）。
目标招募人数为 900 名患者，在中国 8 个中心开展研究。患者按 2:1 的比例随机分配到 MBC 和 TAU 组。患者在急性阶段计划停留 12 周，在维持阶段停留 12 个月。主要结局是 MBC 和 TAU 组在急性阶段的完全缓解率和 QIDS-SR16 总分≤5的患者比例，以及两组在维持阶段的复发率/时间。次要结局包括从基线开始 QIDS-SR16、患者健康问卷-9（PHQ-9）和 17 项汉密尔顿抑郁量表（HAMD-17）参数的变化，以及两组在急性阶段的反应率，以及两组在研究结束时的复发率比较。
中国临床试验注册中心，ChiCTR-OOC-17012566。注册于 2017 年 9 月 4 日进行回溯性注册。
