Development of a Convenient, Automated, Objective Measure of Depression

开发一种方便、自动化、客观的抑郁症测量方法

• 批准号: 7393504
• 负责人: JAMES C. MUNDT
• 金额: $ 52.84万
• 依托单位: HEALTHCARE TECHNOLOGY SYSTEMS, LLC
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-09-15 至 2011-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7393504
• 关键词: Achievement; Acoustics; Adult; Advanced Development; Adverse effects; Affect; Antidepressive Agents; Automation; Biological Markers; Characteristics; Child; Clinical; Clinical Research; Clinical Trials; Collaborations; Computers; Controlled Clinical Trials; Data; Data Collection; Depressed mood; Derivation procedure; Development; Disease; Dose; Double-Blind Method; Elderly; Endogenous depression; Evaluation; Foundations; Functional disorder; Future; General Hospitals; Goals; Healthcare; Individual; Industry; Interview; Investments; Judgment; Life; Major Depressive Disorder; Marketing; Massachusetts; Measurement; Measures; Mental Depression; Mental Health; Mental disorders; Methods; Modeling; NIH Program Announcements; National Institute of Mental Health; Numbers; Outcome; Outcome Measure; Patient Self-Report; Patients; Performance; Pharmaceutical Preparations; Pharmacologic Substance; Pharmacotherapy; Phase; Phase I Clinical Trials; Pilot Projects; Placebo Control; Placebos; Population; Prevalence; Procedures; Process; Protocols documentation; Psyche structure; Randomized; Randomized Clinical Trials; Range; Rate; Research; Research Methodology; Resistance; Sampling; Severities; Signal Transduction; Signs and Symptoms; Site; Small Business Funding Mechanisms; Small Business Innovation Research Grant; Speech; Structure; Suicide; System; Technology; Telephone; Time; Training; Treatment outcome; Validation; Voice; base; biobehavior; cost; design; disability-adjusted life years; double-blind placebo controlled trial; human old age (65+); innovation; instrument; placebo controlled study; programs; response; success; tool; young adult

DESCRIPTION (provided by applicant): Depression is a serious, debilitating disorder that affects millions of people, but treatment research is hampered by the limited reliability of current outcome measures that are often biased by a number of methodological and clinical factors. Such considerations resulted in the issuance of Program Announcement 06-016, "Development of Biomarkers for Mental Health Research and Clinical Utilities" aimed at spurring development of innovative biomarker technologies with clinical utility to assess mental function and dysfunction related to mental illness. The PA identified an "urgent need" for biomarkers as indicators of changes in disorder severity and/or predictors of treatment response that could be effectively applied on an individual basis. Phase I SBIR research successfully established computer-automated assessment of depression severity using fully-structured interactive voice response system interactions with patients and demonstrated feasibility of obtaining valid measures of depression severity and treatment response through vocal acoustic analysis of speech samples obtained over the telephone. As a result of the Phase I pilot study success, Healthcare Technology Systems was successful in persuading an industry sponsor to include vocal acoustic biomarkers as exploratory measures in a methodologically focused randomized clinical trial. This opening creates an opportunity to advance development of vocal acoustic biomarker research faster than would have been possible if Phase II efforts focused solely on technology evaluation in a randomized double-blind placebo controlled trial, as initially envisioned. The Phase II efforts proposed focus on efficient automation of the analytic processes to reduce delivery costs, replication of Phase I results for further validation, generalized extension of the technology for applicability to other patient populations (non-English speakers, children/young adult, and geriatric), and derivation/optimization of multivariate acoustic models to enhance the biomarker sensitivity to treatment response and prediction of the response likelihood for individual patients. The additional data collection, analysis, and presentation of results will be done in collaboration with the Depression Clinical and Research Program at the Massachusetts General Hospital. The product's commercial market is described and a plan for product launch is outlined. Major depression is involved in over 60% of suicides and is a leading cause of disability adjusted life years in the US and worldwide. Development and evaluation of depression treatments in clinical trials is hampered by use of unreliable outcome measures. Establishing a valid, noninvasive, easily obtained, and generalizable biomarker of depression severity and treatment response will contribute to better understanding of depression and development of effective treatments.

描述（由申请人提供）：抑郁症是一种严重的，使人衰弱的疾病，会影响数百万的人，但是治疗研究受到当前结果指标的有限可靠性的阻碍，这些测量通常会受到许多方法论和临床因素的偏见。此类考虑导致发布计划公告06-016：“精神健康研究和临床公用事业生物标志物的开发”旨在促进具有临床实用性创新生物标志物技术的开发，以评估与精神疾病相关的心理功能和功能障碍。 PA将生物标志物的“迫切需求”确定为疾病严重程度变化和/或治疗反应预测因素的指标，可以有效地在个人基础上应用。第一阶段的SBIR研究通过使用完全结构的互动语音响应系统与患者的互动成功建立了对抑郁严重程度的计算机自动化评估，并证明了通过对通过电话获得的语音样本进行声音声学分析获得有效的抑郁症严重程度和治疗反应的可行性。由于第一阶段的试点研究成功，医疗保健技术系统成功地说服了行业赞助商将声带声学生物标志物作为探索性措施包括在方法论上以方法为重点的随机临床试验中。这种开放创造了一个机会，可以比最初设想的随机双盲安慰剂对照试验中仅专注于技术评估的第二阶段努力的努力更快地发展声带的声音生物标志物研究。第二阶段的努力提议着重于分析过程的有效自动化，以降低交付成本，复制I阶段结果，以进一步验证，将技术的广泛扩展扩展到其他患者人群（非英语说话者，儿童/年轻人/年轻人和老年人）以及对模型响应的多个响应措施的范围和优化对生物的敏感性和更优化对生物的敏感性的范围。额外的数据收集，分析和结果将与马萨诸塞州综合医院的抑郁临床和研究计划合作完成。描述了产品的商业市场，并概述了产品发布计划。重大抑郁症涉及自杀的60％以上，是美国和全球范围内残疾调整生命年的主要原因。通过使用不可靠的结局指标，可以阻碍临床试验中抑郁症治疗的发展和评估。建立有效的，无创的，易于获得的抑郁严重程度和治疗反应的可推广生物标志物，将有助于更好地理解抑郁症和有效治疗的发展。