Psychobiologic Factors of the Placebo Response in MDD

MDD 安慰剂反应的心理生物学因素

• 批准号: 7076106
• 负责人: ANDREW F LEUCHTER
• 金额: $ 31.95万
• 依托单位: UNIVERSITY OF CALIFORNIA LOS ANGELES
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-09-29 至 2008-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7076106
• 关键词: alternative medicine; antidepressants; behavioral /social science research tag; brain electrical activity; clinical research; clinical trials; cognition; combination therapy; electroencephalography; human subject; human therapy evaluation; interpersonal relations; locus of control; longitudinal human study; major depression; mental disorder chemotherapy; neural information processing; neuropsychological tests; patient care personnel relations; patient oriented research; personality; placebos; social support network

DESCRIPTION (provided by applicant): Major depressive disorder (MDD) has among the highest placebo response rates of any medical illness. Many MDD subjects in clinical trials who undergo treatment with placebo show improvement comparable to those receiving antidepressant medication. Previous research indicates that interpersonal factors and patient characteristics underlie both medication and placebo response in depression, making MDD an excellent illness model for understanding the origins of the placebo response. This application proposes a line of clinical investigation that will elucidate the role of interpersonal factors and patient characteristics in contributing to improvement seen in placebo treatment of MDD. This study will achieve the following four specific aims: 1) to determine whether administration of placebo or medication pills has effects on improvement of symptoms in addition to interpersonal clinical interaction (ICI) for subjects with MDD; 2) to determine whether pretreatment expectations and the strength of the pharmacotherapeutic alliance are related to the likelihood of clinical improvement during interpersonal clinical interaction, placebo, and medication treatment conditions; 3) to determine if there are pretreatment neurophysiologic, symptom, or cognitive characteristics of subjects that are associated with response to placebo in MDD; and, 4) to examine the effects of interpersonal clinical interaction, placebo pill administration, and medication administration, on brain function in subjects with MDD. We will achieve these aims through a three-step research plan. First, we will enroll 120 subjects meeting criteria for moderate to moderately severe recurrent MDD into one of three treatment conditions: 1) interpersonal clinical interaction (ICI) (thorough baseline assessment and subjects interacting with clinical research personnel on a fixed schedule); 2) placebo treatment (PBO) (assessment and interaction as in ICI plus double-blinded treatment with placebo tablets); and 3) medication treatment (MED) (assessment and interaction as in ICI plus double blinded treatment with antidepressant medication). Second, all subjects will be assessed prior to treatment assignment with measures of pharmacotherapeutic alliance with study personnel, expectation regarding treatment, cognitive processing speed, emotional and neurovegetative symptoms of depression, as well as brain electrical activity. Third, subjects will be assessed over the course of eight weeks of treatment with ratings of symptom change, as well as changes in pharmacotherapeutic alliance, expectation, and brain function. At the end of eight weeks, blind will be broken and all subjects referred for naturalistic treatment where they will be eligible to receive medication free-of charge for 10 months. In addition to testing the specific hypotheses, we plan an exploratory analysis in which we will examine factors that may influence placebo response, such as personality characteristics, perceived social support, and health locus of control. The results of this project will lead to better understanding of the mechanisms of the placebo response in MDD.

描述（由申请人提供）：重度抑郁症（MDD）具有任何医疗疾病中最高的安慰剂反应率之一。在临床试验中，接受安慰剂治疗的许多MDD受试者表现出与接受抗抑郁药的人相当的改善。先前的研究表明，抑郁症的人际交往因素和患者特征既是抑郁症的药物和安慰剂反应，这使得MDD成为理解安慰剂反应起源的出色疾病模型。该应用提出了一系列临床研究，该研究将阐明人际关系因素和患者特征在有助于改善MDD方面的改善中的作用。这项研究将达到以下四个特定目的：1）确定安慰剂或药物药的给药是否对MDD受试者的人际临床相互作用（ICI）除了改善症状； 2）确定预处理预期和药物治疗联盟的强度是否与人际交往期间临床改善的可能性有关； 3）确定与MDD中对安慰剂反应相关的受试者的神经生理学，症状或认知特征； 4）检查人际临床相互作用，安慰剂药给药和药物给药的影响对MDD受试者的脑功能。我们将通过三步研究计划实现这些目标。首先，我们将招募120名受试者符合中度至中度严重的复发性MDD标准为三种治疗条件之一：1）人际关系临床相互作用（ICI）（彻底的基线评估和固定时间表与临床研究人员相互作用）； 2）安慰剂治疗（PBO）（ICI和安慰剂片剂的评估和相互作用以及双盲治疗）； 3）药物治疗（MED）（ICI和抗抑郁药的双盲治疗中的评估和相互作用）。其次，所有受试者将在治疗分配前评估与研究人员的药物治疗联盟，对治疗的期望，认知处理速度，抑郁症的情绪和神经循环症状以及大脑电活动。第三，将在八周的治疗过程中评估受试者的症状变化等级，以及药物治疗联盟，期望和大脑功能的变化。在八周结束时，盲人将被破坏，所有受试者都被转交给自然主义治疗，在那里他们有资格免费获得10个月的药物。除了测试特定的假设外，我们还计划了探索性分析，我们将研究可能影响安慰剂反应的因素，例如人格特征，感知的社会支持和控制的健康基因座。该项目的结果将更好地理解MDD中安慰剂响应的机制。