FLUOXETINE IN GERIATRIC DEPRESSION--RESPONSE PREDICTION

氟西汀治疗老年抑郁症——反应预测

基本信息

批准号：
2392973
负责人：
DEBORAH ACKERMAN
金额：
$ 5.58万
依托单位：
UNIVERSITY OF CALIFORNIA LOS ANGELES
依托单位国家：
美国
项目类别：
财政年份：
1996
资助国家：
美国
起止时间：
1996-04-01 至 1998-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/2392973
关键词：
aging clinical research drug adverse effect fluoxetine human data human old age (65+) human subject human therapy evaluation major depression mental disorder chemotherapy

项目摘要

Fluoxetine has been widely prescribed for depression in elderly patients. Numerous clinical trials have demonstrated that it is more effective than placebo and is comparable to other antidepressants in this population, with response rates ranging from 35 to 60 percent. However, a high rate of improvement among patients who receive placebo in placebo-controlled trials (e.g. 20 to 40 percent) frequently complicates the determination of true drug effect. Therefore, it would be useful to compare characteristics of placebo-responders with fluoxetine-responders to distinguish between placebo and drug effects. The proposed study will compare responders and nonresponders, with data generated from a multicenter, randomized, double-blind, clinical trial to determine the effectiveness and safety of fluoxetine relative to placebo in elderly patients with major unipolar depression (by DSM III-R criteria). More than 670 patients at least 60 years of age participated in this 6-week trial. Subjects were dropped prior to randomization if they demonstrated a 20 percent or greater improvement on the HDRS during a preliminary, one-week placebo period. Similarities and differences between responders and nonresponders will be evaluated with respect to such clinical and demographic factors as severity of illness, length of illness and age of onset, type of symptoms (i.e., anxiety, sleep disturbances), age, sex, race, and concurrent medical illnesses. In addition, because side effects may indicate a biological sensitivity to a drug, the early side effects will be evaluated as possible predictors of response. A response profile will be constructed from those variables found, by logistic and linear regression models, to be associated with good therapeutic outcome. A response profile will be similarly constructed for placebo-responders. Response profiles will then be compared for both drug and placebo groups. Receiver operator characteristic (ROC) curve analysis will be used to evaluate the ability of response profiles to distinguish between responders and nonresponders. Identification of characteristics of people most likely to improve with fluoxetine or placebo can be used to improve therapeutic guidelines and lead to better-designed clinical trials.

氟西汀已被广泛针对老年患者的抑郁症处方。许多临床试验表明，它比安慰剂，与该人群中的其他抗抑郁药相媲美，回应率从35％到60％不等。但是，率很高接受安慰剂在安慰剂控制的患者中的改善试验（例如20％到40％）经常使确定真正的药物作用。因此，比较具有氟西汀反应者的安慰剂反应者的特征区分安慰剂和药物作用。拟议的研究将比较响应者和非反应者，与从多中心，随机，双盲，临床试验，以确定氟西汀相对于安慰剂的有效性和安全性主要单极抑郁症患者（通过DSM III-R标准）。多于这项为期6周的试验参加了670名患者至少60岁。如果受试者证明20 初步，一周中HDR的百分比或更高的改善安慰剂期。响应者与将对这种临床和人口因素是疾病的严重程度，疾病的长度和年龄发作，症状类型（即焦虑，睡眠障碍），年龄，性别，性种族和同时医疗疾病。另外，因为副作用可能表明对药物的生物学敏感性，早期副作用将评估响应的可能预测指标。响应概况将从发现的变量，逻辑和线性构造回归模型，与良好的治疗结果有关。一个响应概况将类似地用于安慰剂 - 反应器。然后，将对药物和安慰剂组进行比较。接收器操作员特征（ROC）曲线分析将用于评估响应概况区分的能力响应者和无反应者。识别人的特征氟西汀或安慰剂最有可能改善治疗指南，并导致精心设计的临床试验。