Feasibility Study To Prevent Post-ICU Depression

预防 ICU 后抑郁症的可行性研究

基本信息

批准号：
7813781
负责人：
CRAIG R WEINERT
金额：
$ 20.39万
依托单位：
UNIVERSITY OF MINNESOTA
依托单位国家：
美国
项目类别：
财政年份：
2008
资助国家：
美国
起止时间：
2008-06-01 至 2012-05-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7813781
关键词：
Acute Acute respiratory failure Address Admission activity Adult Adverse effects Adverse event Advocate American Animal Model Animals Antidepressive Agents Area Behavior Behavioral Symptoms Bioethics Consultants Biology Blinded Brain Clinical Clinical Trials Consent Critical Care Critical Illness Data Depressive disorder Detection Development Disease Dose Double-Blind Method Effectiveness Elements Enrollment Epidemiology Escitalopram Feasibility Studies Feeling suicidal Frequencies Future Goals Health Health Care Costs Hour Human Immunotherapy Incidence Inflammatory Injury Intensive Care Units Interdisciplinary Study Intervention Interview Knowledge Masks Measurement Measures Mechanical ventilation Mediating Medical Medicine Mental Depression Mood Disorders Moods National Institute of Mental Health Neuronal Injury Neurosciences Research Outcome Outcomes Research Participant Patients Pharmaceutical Preparations Phenotype Placebo Control Prevention Prevention strategy Primary Prevention Procedures Protocols documentation Proxy Psyche structure Psychiatrist Psychiatry Psychopathology Quality of life Randomized Randomized Clinical Trials Recovery Rehabilitation therapy Research Research Personnel Research Project Grants Research Subjects Respiratory Failure Risk Risk Factors Safety Sample Size Schedule Selective Serotonin Reuptake Inhibitor Services Severities Site Strategic Planning Stratification Stress Survivors Symptoms Testing Time Titrations Treatment Protocols Withdrawal Symptom arm base central nervous system injury clinically relevant clinically significant cytokine depressive symptoms design effectiveness trial environmental stressor experience follow-up improved innovation instrument interest melanoma mortality neurotrophic factor novel numb protein placebo controlled study prevent randomized trial research study success therapy development treatment effect

项目摘要

DESCRIPTION (provided by applicant): Twenty-eight percent of patients that require mechanical ventilation for more than 2 days develop a new depressive disorder within two months. Preventing depression would likely improve the health, rehabilitation and quality of life for the approximately half-million Americans that annually survive respiratory failure and prolonged mechanical ventilation. In human studies and analogous animal models, depression can be substantially prevented if antidepressant medications are given during the period of inflammatory or environmental stress. This leads to our hypothesis that depression can be prevented by early administration of SSRI medications to patients with acute respiratory failure thereby accelerating their return to best possible function. However, the barriers to conducting a large, multi-center depression prevention trial in critically ill humans are significant. Conducting a smaller feasibility study is a logical first step. Therefore, the objective of this revised R34 application by a new investigator with research experience in critical care medicine and psychiatry is to establish the feasibility of conducting a large-scale randomized trial to administer escitalopram to patients very early in the course of acute respiratory failure. A randomized, double-blind, placebo-controlled, single-site primary prevention trial with a scheduled dose escalation is proposed to determine if it is feasible to rapidly identify eligible subjects; obtain a high proportion of consent (> 60%) from proxies; enroll 100 subjects over 2 years; administer at least 80% of planned doses; have > 90% 8 week follow-up and successfully mask active medication assignment. The trial will also determine the proportion of subjects that decline re-consent, use off-protocol antidepressants or develop antidepressant withdrawal symptoms. Medical adverse event and suicidal ideation rates will be recorded. While the modest sample size precludes definitive hypothesis testing of differences in depression scores or adverse event rates between the experimental arms, these data will be used to estimate design parameters and to select a primary depression measure for a subsequent effectiveness trial. This application is responsive to NIMH PAR-06-248 From Intervention Development to Services: Exploratory Research Grants and addresses two priority areas in the NIMH Strategic Plan on Mood Disorders Research. The interdisciplinary research team includes a critical care clinician and researcher, psychiatrist, bioethicist, research subject advocate and a clinical trialist.

描述（由申请人提供）：需要机械通气超过 2 天的患者中有 28% 在两个月内出现新的抑郁症。预防抑郁症可能会改善每年大约 50 万患有呼吸衰竭和长期机械通气的美国人的健康、康复和生活质量。在人类研究和类似的动物模型中，如果在炎症或环境应激期间给予抗抑郁药物，则可以基本上预防抑郁症。这导致我们的假设是，通过早期给急性呼吸衰竭患者服用 SSRI 药物，可以预防抑郁症，从而加速他们恢复最佳功能。然而，在危重病人身上进行大型、多中心抑郁症预防试验的障碍是巨大的。进行规模较小的可行性研究是合乎逻辑的第一步。因此，由一位具有重症监护医学和精神病学研究经验的新研究者修订的 R34 申请的目的是确定进行大规模随机试验的可行性，以在急性呼吸衰竭病程的早期对患者施用艾司西酞普兰。建议进行一项随机、双盲、安慰剂对照、单中心一级预防试验，并按计划进行剂量递增，以确定快速识别合格受试者是否可行；获得代理人的高比例同意（> 60%）； 2年内招收100个科目；至少服用计划剂量的 80%； 8 周随访率超过 90%，并成功掩盖了主动药物分配。该试验还将确定拒绝重新同意、使用方案外抗抑郁药或出现抗抑郁药戒断症状的受试者比例。将记录医疗不良事件和自杀意念发生率。虽然样本量适中，无法对实验组之间的抑郁评分或不良事件发生率差异进行明确的假设检验，但这些数据将用于估计设计参数并为后续有效性试验选择主要抑郁指标。此应用程序响应 NIMH PAR-06-248 从干预开发到服务：探索性研究补助金，并解决 NIMH 情绪障碍研究战略计划中的两个优先领域。跨学科研究团队包括重症监护临床医生和研究员、精神病学家、生物伦理学家、研究课题倡导者和临床试验师。