Improving Psychiatric Interventions at the End of Life

改善临终精神病干预

• 批准号: 8137046
• 负责人: SCOTT A IRWIN
• 金额: $ 18.04万
• 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 2015-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8137046
• 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）：这是一份职业发展计划提案，旨在研究临终者的精神问题和干预措施，特别是重度抑郁症。临终抑郁症等问题给公共卫生带来的负担是巨大的，不仅对患者，而且对他们的亲人来说也是如此。改善这一人群的精神科护理和干预措施每年将改善超过一百万人的生活，让患者和家人能够在一起度过最后的时光，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仅剩几周生命的患者来说效果不够快或不够频繁。小型研究和我们的试点已经为哌醋甲酯在临终关怀机构中快速治疗抑郁症的安全性和有效性提供了初步证据。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，从一名成功的基础科学家转变为一名以患者为导向的研究人员和临床试验人员，特别关注在弱势群体和患有疾病的人群中进行临床试验。总体目标是将候选人培养成一名独立科学家，他将在一个新的且至关重要的领域——精神科临终关怀领域获得 R01 资助。该提案符合 NIMH 的战略计划，即通过检查社区和干预实施方法、它们如何影响干预结果，并可能提供知识库以将循证干预措施付诸实践，加强心理健康干预措施在不同护理环境中的应用。具体目标：在目前重性抑郁发作并接受临终关怀的患者中，将进行一项为期 28 天的双盲、比较对照、灵活剂量试验，哌醋甲酯与艾司西酞普兰单药治疗的比较：1) 比较疗效和起效行动，以及 2) 使用这些药物治疗该人群重度抑郁发作的相对安全性和耐受性。我们假设哌醋甲酯治疗将：1）减轻抑郁症状的严重程度，2）比艾司西酞普兰显着更快地诱导重度抑郁发作的反应。方法：将进行一项为期 28 天的双盲、比较对照、灵活剂量试验，比较哌醋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、有效性和起效时间。在前十五天内，剂量将逐渐调整至可耐受的效果或副作用。在研究的剩余时间内，患者将保持最终稳定剂量。结论：从事临终关怀工作的精神科医生很少，而作为调查人员的则更少。资助这项提案将为我提供必要的经验，以提高临终时识别和治疗精神问题的科学性。有效的治疗对于患者、其亲人和护理人员具有重要意义。如果该试验的结果有利于使用哌醋甲酯，则研究结果将用于设计更大规模、随机、多中心和对照试验。结果还可用于设计接受临终关怀的患者和/或所有三个人群的护理人员的研究。 公共健康相关性：该提案的目标是培训我成为一名临床试验员，并改进目前接受临终关怀的患者抑郁症的精神药理学治疗。接受临终关怀的患者中抑郁症非常普遍，而目前针对抑郁症的循证干预措施对于仅剩几周生命的患者来说效果不够快或不够频繁。本研究提出了一项为期 28 天的双盲、比较对照、灵活剂量试验，对哌甲酯与艾司西酞普兰单药疗法进行评估，以评估：1）哌醋甲酯与艾司西酞普兰治疗重度抑郁发作的疗效和起效比较，以及 2）在接受临终关怀的患者中使用哌醋甲酯与艾司西酞普兰的安全性和耐受性比较。