Antidepressant Treatment at an Inner City Asthma Clinic

内城哮喘诊所的抗抑郁治疗

基本信息

批准号：
8463234
负责人：
E SHERWOOD BROWN
金额：
$ 42.87万
依托单位：
UT SOUTHWESTERN MEDICAL CENTER
依托单位国家：
美国
项目类别：
财政年份：
2010
资助国家：
美国
起止时间：
2010-07-01 至 2015-05-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8463234
关键词：
Acute Adherence Admission activity Adrenal Cortex Hormones Adult Advair Agonist Antidepressive Agents Anxiety Appointment Asthma Breathing British Bronchodilator Agents Caring Chronic Disease Citalopram Clinic Clinic Visits Clinical Clinical Trials Control Groups Data Depressed mood Depressive disorder Disease remission Dose Double-Blind Method Escitalopram Ethnic group Fluticasone propionate Frequencies Goals Grant Guidelines Hamilton Rating Scale for Depression Heart Diseases Hematological Disease Hospitals Household Income Intervention Lung diseases Major Depressive Disorder Measures Medical Mental Depression Minority Mood Disorders Moods Morbidity - disease rate National Heart, Lung, and Blood Institute Oral Outcome Outcome Measure Outpatients Participant Patients Persons Pharmaceutical Preparations Phase Physical Function Pilot Projects Placebo Control Placebo Effect Placebos Population Prednisone Prevalence Prevention Psychosocial Factor Pulmonary Function Test/Forced Expiratory Volume 1 Quality of life Questionnaires Race Randomized Research Risk Risk Factors Safety Salmeterol Selective Serotonin Reuptake Inhibitor Severities Signal Transduction Steroids Subgroup Symptoms Time Visit base depressive symptoms design effective therapy follow-up improved inner city medication compliance meter milligram mortality primary outcome programs public health relevance response statistics tertiary care

项目摘要

DESCRIPTION (provided by applicant): Asthma is a common, severe, and debilitating medical condition. The prevalence of asthma and asthma-related morbidity and mortality has increased in recent years. Data suggest that depressive symptoms and disorders are common in asthma patients and may be a risk factor for asthma-related morbidity. However, minimal data are available on the treatment of persons with depression and asthma. We initiated a research program on the interactions between asthma and depression. Pilot data were collected looking at the efficacy of citalopram versus placebo in outpatients with major depressive disorder and asthma. The goal was to establish feasibility and safety, determine appropriate outcome measures, and identify patient groups most responsive to the antidepressant therapy. The group receiving citalopram showed greater sustained remission of depressive symptoms and required significantly less oral corticosteroids for asthma symptom control than the group receiving placebo. Change in depressive symptom severity was associated with positive change in asthma-related outcomes. Remitters from depression had greater improvement in scores on measures of asthma symptom control and asthma-related quality of life, and required less as-needed bronchodilator use. Thus, improvement in depression was associated with improvement in asthma. A subsample with more severe depression and frequent oral corticosteroid use showed positive changes in depressive and asthma symptoms and less oral corticosteroid use, all favoring the antidepressant group. We now propose a definitive antidepressant trial, in response to the R18 announcement, in outpatients with asthma and major depression based on pilot study information gained regarding effect sizes, predictors of response, and sensitivity of outcome measures. A 12-week randomized, double-blind, placebo-controlled, acute phase trial of escitalopram is proposed in 80 outpatients with asthma and major depression with a baseline Hamilton Rating Scale for Depression score of e 20 and who frequently require oral corticosteroids and in a group of 142 depressed asthma patients with less severe depression and/or less frequent corticosteroid use. A 12-week continuation phase for depression responders is also proposed. Changes in Asthma Control Questionnaire scores (primary outcome measure), oral corticosteroid use, depressive symptoms, quality of life, and asthma medication adherence will be assessed as well as the relationship between changes in depressive and asthma symptom severity. A research team with expertise in depression clinical trials, mood disorders, asthma, and statistics will conduct the trial. The findings will have implications for asthma treatment.

描述（由申请人提供）：哮喘是一种常见，严重且使人衰弱的医疗状况。近年来，哮喘和与哮喘相关的发病率和死亡率的患病率有所提高。数据表明，抑郁症状和疾病在哮喘患者中很常见，可能是与哮喘相关的发病率的危险因素。但是，关于治疗抑郁症和哮喘患者的治疗最少的数据。我们启动了一项有关哮喘与抑郁症之间相互作用的研究计划。收集了先导数据，以查看西妥优兰与安慰剂在患有严重抑郁症和哮喘的门诊患者中的疗效。目的是建立可行性和安全性，确定适当的结果指标，并确定对抗抑郁治疗最有反应的患者组。接受西可毒兰素的组显示出比接受安慰剂的组更大的抑郁症状缓解，并且对哮喘症状控制的口服皮质类固醇需要明显少得多。抑郁症状严重程度的变化与哮喘相关结果的积极变化有关。抑郁症的汇率对哮喘症状控制和与哮喘相关的生活质量的评分有了更大的改善，并且需要减少需要的支气管扩张剂的使用。因此，抑郁症的改善与哮喘的改善有关。具有更严重抑郁症和频繁口服皮质类固醇的子样本在抑郁症和哮喘症状和口服皮质类固醇较少的情况下显示出正变化，所有这些都有利于抗抑郁剂组。现在，我们提出了一项针对R18公告的确切抗抑郁药试验，该试验是基于哮喘和重度抑郁症的门诊病人，基于试点研究的信息，有关效果大小，反应的预测因素以及结果度量的敏感性。提议在80名患有哮喘和重度抑郁症的门诊病人中进行一项为期12周的随机，双盲，安慰剂对照，急性期试验，其基线汉密尔顿抑郁症评分为E 20，并且经常需要口服皮质类固醇，并且在142例抑郁症患者中经常使用抑郁症的抑郁症患者抑郁症较低，并且患有较少的抑郁症患者，患有较少的抑郁症患者，较少频率频率频率频率较低。还提出了一个为期12周的抑郁响应者延续阶段。将评估哮喘控制问卷得分（主要结局度量），口服皮质类固醇，抑郁症状，生活质量和哮喘药物依从性的变化以及抑郁症和哮喘症状严重程度的变化之间的关系。在抑郁症临床试验，情绪障碍，哮喘和统计学方面具有专业知识的研究团队将进行试验。这些发现将对哮喘治疗有影响。