Johnson Kristen M, Devine Jacob M, Ho Kai Fai, Howard Kellee A, Saretsky Todd L, Jamieson Carol A
Janssen Global Services, LLC, Raritan, New Jersey, USA.
Oxford Outcomes, San Francisco, California, USA.
J Clin Psychiatry. 2016 Dec;77(12):1681-1686. doi: 10.4088/JCP.15m10253.
This study investigated the suitability of the Montgomery-Asberg Depression Rating Scale (MADRS), with a 24-hour recall period (MADRS-24hr), to assess the rapid onset of the antidepressant effect of a treatment in patients with treatment-resistant depression (TRD). Psychometric properties of the MADRS-24hr were assessed together with qualitative assessment of content validity.
Content validity was assessed using semistructured interviews conducted from November 2013 to December 2013 in patients (18-64 years old) with TRD who met DSM-IV diagnostic criteria and health care professionals (HCPs) experienced in treating major depressive disorder and familiar with using the MADRS. The psychometric properties of MADRS-24hr were evaluated using data from 2 randomized clinical studies involving patients with TRD.
A total of 23 patients (15 [65%] women) with TRD (mean age = 45 years) and 11 HCPs were interviewed. With the exception of reduced sleep, the majority of patients and HCPs reported that the items captured in the MADRS can fluctuate in a 24-hour period. The majority of participants also reported that a meaningful change in depression symptoms could be assessed in a 24-hour recall period, except for reduced sleep and appetite. Assessment of the psychometric properties of the MADRS-24hr showed that this instrument had high internal consistency reliability (Cronbach α of 0.84 and 0.91) and test-retest reliability (intraclass correlation coefficients of 0.96 and 0.91), had construct validity, and was responsive to change following an intervention.
Overall, results suggest that MADRS-24hr can be used to assess the rapid onset of antidepressant efficacy of a treatment in patients with TRD.
ClinicalTrials.gov identifiers: NCT01627782 and NCT01640080.
本研究调查了蒙哥马利-阿斯伯格抑郁评定量表（MADRS），采用24小时回忆期（MADRS-24hr），用于评估难治性抑郁症（TRD）患者治疗中抗抑郁作用的快速起效情况。同时评估了MADRS-24hr的心理测量特性以及内容效度的定性评估。
2013年11月至2013年12月，对符合DSM-IV诊断标准的TRD患者（18 - 64岁）以及有治疗重度抑郁症经验且熟悉使用MADRS的医疗保健专业人员（HCPs）进行半结构化访谈，以评估内容效度。使用来自2项涉及TRD患者的随机临床研究的数据评估MADRS-24hr的心理测量特性。
共访谈了23例TRD患者（15例[65%]为女性）（平均年龄 = 45岁）和11名HCPs。除睡眠减少外，大多数患者和HCPs报告称MADRS中的项目在24小时内会有波动。大多数参与者还报告称，除睡眠和食欲减少外，在24小时回忆期内可评估抑郁症状的有意义变化。对MADRS-24hr心理测量特性的评估表明，该工具具有较高的内部一致性信度（Cronbach α分别为0.84和0.91）和重测信度（组内相关系数分别为0.96和0.91），具有结构效度，且对干预后的变化有反应。
总体而言，结果表明MADRS-24hr可用于评估TRD患者治疗中抗抑郁疗效的快速起效情况。
ClinicalTrials.gov标识符：NCT01627782和NCT01640080。
