权益分类	功能权益	普通用户	{{item.name}}会员
{{category.name}}	{{benefitItem.name}}

Improving Psychiatric Interventions at the End of Life

改善临终时的精神干预

基本信息

批准号：
8485678
负责人：
SCOTT A IRWIN
金额：
$ 17.93万
依托单位：
UNIVERSITY OF CALIFORNIA, SAN DIEGO
依托单位国家：
美国
项目类别：
财政年份：
2013
资助国家：
美国
起止时间：
2013-11-01 至 2015-12-04
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8485678
关键词：
Adverse effects Affect Antidepressive Agents Area Caregivers Caring Clinical Conduct Clinical Trials Data Development Disease remission Dose Double-Blind Method Escitalopram Evidence based intervention Family Funding Goals Hamilton Rating Scale for Depression Hospice Care Hour Intervention Length Life Major Depressive Disorder Measures Mediator of activation protein Mental Depression Mental Health Mentors Methods Methylphenidate National Institute of Mental Health Outcome Patients Pharmaceutical Preparations Population Psychiatric therapeutic procedure Psychiatrist Public Health Quality of life Randomized Randomized Controlled Trials Research Design Research Personnel Safety Science Scientist Severities Site Strategic Planning Testing Time Training Treatment Efficacy United States National Institutes of Health Work base career development community intervention comparative comparative efficacy control trial depressive symptoms design effective therapy end of life experience flexibility hospice environment improved knowledge base loved ones multi-site trial patient oriented programs psychopharmacologic public health relevance response single episode major depressive disorder

项目摘要

DESCRIPTION (provided by applicant): This is a proposal for a career development program preparing for study of psychiatric issues and interventions for people near the end-of-life, specifically major depressive disorders. The public health burden of issues such as depression at the end-of-life is enormous, not only for the patients, but also their loved ones. Improved psychiatric care and interventions in this population would improve the lives of over a million people a year, allowing patients and families to be engaged in their final hours together, rather than to spend them in misery. Current evidence-based interventions for depression do not work fast enough or frequently enough for patients with only weeks to live. Small studies and our pilot have provided initial evidence for the safety and efficacy of methylphenidate for rapidly treating depression in hospice settings. A mentoring team led by Drs. Dilip Jeste and Charles von Gunten will guide the development of the Candidate in the transformation from a successful basic scientist to a patient-oriented researcher and clinical trialist, with a special focus on conducting clinical trials in vulnerable and medically-ill populations. The overall goal is to develop the candidate into an independent scientist who would obtain R01 funding in a new and critically important area, psychiatric hospice care. This proposal is consistent with the NIMH strategic plan of strengthening the application of mental health interventions in diverse care settings by examining community and intervention delivery approaches, how they may affect intervention outcomes, and potentially providing a knowledge base to move evidence-based interventions into practice. SPECIFIC AIMS: In patients receiving hospice care with a current major depressive episode, a 28-day double-blind, comparator controlled, flexible dose trial of methylphenidate vs. escitalopram monotherapy will be conducted to assess both: 1) the comparative efficacy and onset of action, and 2) the comparative safety and tolerability of using these medications for treating major depressive episodes in this population. We hypothesize that treatment with methylphenidate will both: 1) Reduce the severity of depressive symptoms and 2) Induce a response of major depressive episodes significantly faster than escitalopram. Methods: A 28-day double-blind, comparator controlled, flexible dose trial of methylphenidate monotherapy vs. escitalopram monotherapy investigating the safety, tolerability, efficacy, and time to efficacy for the treatment of major depression in patients receiving hospice care will be conducted. Dose will be titrated to tolerable effects or side-effects in the first fifteen days. Patients will remain on the final stable dose for the remainder of the study. Conclusions: There are very few psychiatrists working in end-of-life care, and even fewer who are investigators. Funding this proposal will give me the experience necessary to improve the science of recognizing and treating psychiatric issues at the end-of-life. Effective treatments have significant relevance for patients, their loved ones, and caregivers. Should the results of this trial favor use of methylphenidate, the findings will be used to design larger, randomized, multi-site, and controlled trials. The results may also be used to design studies of patients receiving pre-hospice care and/or of caregivers of all three populations.

描述（由申请人提供）：这是一个职业发展计划的建议，为接近生命尽头的人，特别是重度抑郁症的精神问题和干预措施的研究做准备。诸如临终抑郁症等问题的公共卫生负担是巨大的，不仅对患者，而且对他们的亲人。改善这一人群的精神病护理和干预措施每年将改善100多万人的生活，使患者和家人能够在最后的几个小时里一起度过，而不是在痛苦中度过。目前针对抑郁症的循证干预措施对于只有几周生命的患者来说不够快或不够频繁。小型研究和我们的试点提供了初步的证据，哌醋甲酯快速治疗抑郁症在临终关怀设置的安全性和有效性。由Dilip Jeste和Charles von Gunten博士领导的指导团队将指导候选人从成功的基础科学家转变为以患者为导向的研究人员和临床试验者的发展，特别关注在脆弱和医疗疾病人群中进行临床试验。总体目标是将候选人发展成为一名独立的科学家，他们将在一个新的和至关重要的领域获得R 01资金，精神病临终关怀。这一建议是符合NIMH的战略计划，加强精神卫生干预措施在不同的护理环境中的应用，通过检查社区和干预措施的提供方法，他们如何可能影响干预结果，并可能提供一个知识基础，将循证干预措施付诸实践。具体目标：在接受临终关怀的当前重度抑郁发作患者中，将进行一项为期28天的双盲、对照药物对照、灵活剂量试验，比较哌甲酯与艾司西酞普兰单药治疗，以评估：1）比较疗效和起效时间，2）在该人群中使用这些药物治疗重度抑郁发作的比较安全性和耐受性。我们假设哌醋甲酯治疗将：1）降低抑郁症状的严重程度，2）比艾司西酞普兰更快地诱导重性抑郁发作的反应。研究方法：将进行一项为期28天的双盲、对照药物对照、灵活剂量试验，比较哌甲酯单药治疗与艾司西酞普兰单药治疗，研究接受临终关怀的患者治疗重度抑郁症的安全性、耐受性、疗效和至疗效时间。在前15天内，将剂量滴定至可耐受的作用或副作用。在研究的剩余时间内，患者将继续接受最终稳定剂量。结论：从事临终关怀的精神科医生很少，而从事调查的精神科医生就更少了。资助这项提案将使我获得必要的经验，以提高在生命结束时识别和治疗精神病问题的科学。有效的治疗对患者、他们的亲人和照顾者有着重要的意义。如果这项试验的结果有利于哌醋甲酯的使用，研究结果将用于设计更大的，随机的，多中心的，对照试验。研究结果也可用于设计对接受临终关怀前护理的患者和/或所有三个人群的护理人员的研究。