Improving Psychiatric Interventions at the End of Life

改善临终精神病干预

• 批准号: 8310037
• 负责人: SCOTT A IRWIN
• 金额: $ 2.74万
• 依托单位: SAN DIEGO HOSPICE AND PALLIATIVE CARE
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-09-02 至 2013-04-04
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8310037
• 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

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. PUBLIC HEALTH RELEVANCE: The goal of this proposal is to train me to become a clinical trialist and improve upon current psychopharmacological treatments for depression in patients receiving hospice care. Depression in patients receiving hospice care is highly prevalent, and the current evidence-based interventions for depression do not work fast enough or frequently enough for patients with only weeks to live. This study proposes a 28-day double-blind, comparator controlled, flexible dose trial of methylphenidate vs. escitalopram monotherapy to assess: 1) the comparative efficacy and onset of action of methylphenidate vs. escitalopram for treating major depressive episodes, and 2) the comparative safety and tolerability of using methylphenidate vs. escitalopram in patients receiving hospice care.

描述（由申请人提供）：这是一项职业发展计划的建议，为研究精神病问题和干预措施的研究准备，尤其是重大抑郁症。抑郁症在终止生命的问题的公共卫生负担不仅对患者，而且对亲人而言都是巨大的。改善精神病护理和对该人群的干预措施将改善每年超过100万人的生活，使患者和家庭能够共同参与最后的时间，而不是将他们花在痛苦中。当前的基于证据的抑郁症干预措施不能足够快，或者频繁地使只有数周的生活患者。小型研究和我们的飞行员提供了哌醋甲酯在临终关怀环境中快速治疗抑郁症的安全性和有效性的初步证据。由博士领导的指导团队。 Dilip Jeste和Charles von Gunten将指导候选人的发展，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，特别着重于在易受伤害和医疗的人群中进行临床试验。总体目标是将候选人发展成独立的科学家，他们将在新的重要领域的精神病临终关怀护理中获得R01的资金。该提案与NIMH战略计划一致，即通过检查社区和干预措施，如何影响干预成果以及可能提供知识库以将基于证据的干预措施转移到实践中，从而加强心理健康干预措施在各种护理环境中的应用。具体目的：在接受当前重大抑郁症的临终关怀护理的患者中，将进行28天的双盲，比较器受控的，灵活的甲苯甲酸酯与依他斯酸抗氧释酰丙者单一疗法的柔性剂量试验，以评估：1）比较疗效和动作的比较功效和2）用这些药物对这些药物进行比较安全性和抑郁症的比较安全性。我们假设用哌醋甲酯的治疗将同时进行：1）减少抑郁症状的严重程度，2）诱导主要抑郁发作的反应明显快得明显快得多。方法：一项为期28天的双盲，比较器控制的，柔性剂量试验对依他普兰单一疗法的调查，研究将进行安全性，耐受性，有效性以及对接受临终关怀护理患者的重大抑郁症治疗的功效的时间。剂量将在最初的15天内滴定为可耐受的效果或副作用。在研究的其余部分中，患者将保持最终稳定剂量。结论：从事临终护理的精神科医生很少，甚至更少的调查人员。为这项建议提供资金将为我提供改善在终止生命终止的精神病问题科学的必要经验。有效的治疗对患者，亲人和看护人具有很大的相关性。如果该试验的结果有利于使用哌醋甲酯，则发现将用于设计更大，随机，多站点和对照试验。该结果还可以用于设计接受曾接受培育前护理和/或所有三个人群护理人员的患者的研究。 公共卫生相关性：该提案的目的是训练我成为一名临床试验者，并改善接受临终关怀护理患者的抑郁症的当前心理药物治疗。接受临终关怀护理的患者的抑郁症非常普遍，目前的基于证据的抑郁症干预措施效果不够快，或者频繁地不足以使只有数周的寿命。这项研究提出了28天的双盲，比较器控制的，辅助甲酯与依他弗兰单一疗法的柔性剂量试验，以评估：1）比较性和伴抗肌肉甲抗抗氧蛋白甲抗甲甲化甲甲化甲酸抗性抗抑制作用的比较功效和作用发作，以治疗主要的抑郁症发作，以及2）使用甲基苯二酚VS.抗磷酸酯的比较安全性和耐受性。