Convenient, automated, objective measure of depression

描述(由申请人提供)：这项研究旨在证明使用交互式语音应答(IVR)技术获得抑郁症严重程度测量的可行性，该技术与临床医生管理的汉密尔顿抑郁评定量表(HAMD)访谈相当或更好。医生将把40名开始治疗新的抑郁症发作的患者转介给这项自然主义的开放标签研究。临床医生的HAMD将在基线以及第2、4和6周获得。从基线开始，受试者将每天致电IVR系统，提供经常与抑郁症相关的8种症状的严重程度评级，以及自上次通话以来的临床变化评级。从基线开始，之后每周，受试者将完成HAMD的有效IVR版本，这是抑郁症状快速清单(QID)的IVR实施，通过个性化记录他们在基线时的经历，提供自基线以来临床变化的评级，并将提供由标准化方案引发的语音样本，供Peter Snyder博士进行后续声学分析。主轴分解将被用来定义抑郁严重程度的统计约束的、理论上可解释的多变量因子。将分析与临床医生HAMD评估有关的受试者之间和受试者内部的差异，并将其与从日常抑郁问题(DQD)、记忆增强的治疗回顾评估(MERET)、IVR HAMD和QID以及从IVR收集的语音样本中提取的语音特征进行比较，并在Snyder博士的实验室分析。提高抑郁症治疗研究中使用的评估工具的质量可能会逆转目前随机临床试验中安慰剂反应率的上升趋势，减少失败试验的数量，提供更准确的治疗开始测量，并为化合物之间的疗效比较提供更公平的竞争环境。最终，这种努力可能会以更低的开发成本缩短药物开发周期。

DESCRIPTION (provided by applicant): This research is aimed at demonstrating the feasibility of obtaining measures of depression severity using interactive voice response (IVR) technology that are equivalent or superior to clinician-administered Hamilton Depression Rating Scale (HAMD) interviews. Physicians will refer forty patients beginning treatment for a new episode of depression to the naturalistic, open-label study. Clinician HAMDs will be obtained at baseline and Weeks 2, 4 and 6. Beginning at baseline, subjects will call an IVR system daily to provide severity ratings of eight symptoms frequently associated with depression and a rating of clinical change since their last call. Beginning at baseline, and weekly thereafter, subjects will complete a validated IVR version of the HAMD, an IVR implementation of the Quick Inventory of Depressive Symptomatology (QIDS), provide a rating of clinical change since baseline enhanced by personalized recording of their experiences at baseline, and will provide speech samples elicited by a standardized protocol for subsequent acoustical analysis by Dr. Peter Snyder. Principal axis factoring will be used to define a statistically constrained, theoretically interpretable multivariate factor of depressive severity. Derived factor scores will be analyzed for between- and within-subjects variance related to clinician HAMD assessments and compared to depression metrics derived from the Daily Questions on Depression (DQD), the Memory Enhanced Retrospective Evaluation of Treatment (MERET), the IVR HAMD and QIDS, and speech characteristics extracted from the speech samples collected by IVR and analyzed in Dr. Snyder's laboratory. Improving the quality of assessment instruments used in depression treatment research might reverse the currently increasing rates of placebo response in randomized clinical trials, reduce the number of failed trials, provide more accurate measurement of therapeutic onset, and provide a more level playing field for comparing efficacy between compounds. Ultimately such efforts may decrease the drug development cycle at lower developmental costs.