Does depression affect quality of decisions to participate in clinical trials?

描述（由申请人提供）：重度抑郁症（MDD）是世界上最普遍和最衰弱的精神障碍之一。招募抑郁症患者的临床试验有助于开发和评估抑郁症的有效治疗方法。临床试验参与者的安全性由机构审查委员会（irb）监督。对抑郁症患者是否有能力对参与研究做出明智决定的担忧一直是争论的源头。包括IRB审稿人在内的许多人都认为，精神障碍会损害决策。然而，在研究背景下，关于抑郁症患者决策能力的实证数据很少。因此，内部审查委员会必须根据公认的“智慧”而不是经验证据提出建议。这可能导致IRBs关于抑郁症个体适当保护水平的建议存在差异。虽然存在评估个人知情同意能力的工具，但它们只能确定一个人是否知道如何做出决定，而不能确定一个决定是否符合一个人的偏好，是否符合他或她的最大利益。因此，抑郁症是否影响决策质量的问题仍未得到解决。该项目旨在提供数据，最终帮助那些负责研究参与者健康的人选择适当程度的保护措施，以保护参与研究的抑郁症患者。这将通过使用卫生经济学和卫生决策的工具来了解重度抑郁症对假设临床试验的风险和收益评估的影响来实现。将检查抑郁症患者做出的决定是否符合他们对更好的健康状态的偏好，并将其与慢性疼痛（一种相对致残的非精神疾病）、重度抑郁症和疼痛共病患者做出的决定以及健康对照者的决定进行比较。这项研究是对NIMH战略目标3和4的回应。这项研究的结果有可能通过向主要利益相关者提供数据来简化涉及抑郁症患者的研究，这些数据要么支持需要额外的保护，要么决定不需要额外的保护。它可能会揭示抑郁症患者在决策过程中遇到的困难，从而为干预提供一个新的重点。该项目描述了在Laura Dunn博士的指导下发展心理学学术生涯的五年计划，Laura Dunn博士在生物伦理学和提供知情同意能力相关问题方面拥有丰富的经验。此外，共同导师里卡多·穆克兹（Ricardo Muqoz）博士将就该项目与抑郁症有关的各个方面提供指导，顾问乔纳森·巴伦（Jonathan Baron）博士将在决策方面提供协助和培训。最终，该项目将允许在相互信息的关系中建立一条结合精神病理学和决策的调查线；该奖项所提供的科学发展将为成为一名成功的独立研究者提供必要的技能。

DESCRIPTION (provided by applicant): Major depressive disorder (MDD) is one of the most prevalent and debilitating mental disorders in the world. Clinical trials recruiting depressed individuals are instrumental in the development and evaluation of effective treatments for depression. The safety of participants in clinical trials is overseen by the Institutional review boards (IRBs). Concerns about abilities of people with depression to make an informed decision about research participation have been an ongoing source of debate. Many, including IRB reviewers, presume that mental disorders compromise decision-making. However, empirical data regarding decision-making abilities of depressed persons in research context are scant. IRBs must therefore make recommendations based on accepted "wisdom" rather than empirical evidence. This likely results in the variability in recommendations of IRBs regarding the appropriate level of protection of depressed individuals. Whereas instruments assessing the individuals' capacity to give informed consent exist, they can only determine whether a person knows how to make a decision, but not whether a decision is consistent with a person's preferences and is in his or her best interest. Thus, the question of whether depression affects the quality of decisions remains unaddressed. The proposed project aims to provide data that will ultimately help those entrusted with the well-being of research participants to select appropriate degree of safeguards for depressed individuals enrolling in research. This will be accomplished by using tools from health economics and health decision-making to understand the influence of MDD on the evaluation of risks and benefits of hypothetical clinical trials. Decisions made by depressed individuals will be examined for consistency with their preferences for better health states, and compared to decisions made by individuals with chronic pain (a comparably disabling non-psychiatric condition), with comorbid MDD and pain, and to decisions of healthy controls. This research is responsive to NIMH Strategic Objectives 3 and 4. Results of this study have the potential to streamline research involving depressed persons by providing major stakeholders the data which either supports the need for additional protection, or determines that no additional safeguards are necessary. It may shed light on the difficulties depressed individuals experience with decision-making, thereby providing a new focus of interventions. This project describes a five-year program to develop an academic career in psychology under the mentorship of Dr. Laura Dunn, who has extensive experience in bioethics and issues related to capacity to provide informed consent. In addition, Dr. Ricardo Muqoz, a co-mentor, will provide guidance on aspects of the project related to depression, and Dr. Jonathan Baron, a consultant, will provide assistance and training in decision-making. Ultimately, this project will allow the establishment of a line of inquiry combining psychopathology and decision-making in a mutually informative relationship; the scientific development afforded by this award will provide the skills necessary to become a successful independent investigator.