Columbia University College of Physicians and Surgeons, New York State Psychiatric Institute, New York, NY 10032, USA.
Psychol Med. 2013 May;43(5):975-82. doi: 10.1017/S0033291712001882. Epub 2012 Sep 13.
This study is a randomized, prospective, investigation of the relationships between clinical trial design, patient expectancy and the outcome of treatment with antidepressant medication. Method Adult out-patients with major depressive disorder (MDD) were randomized to either placebo-controlled (PC, 50% probability of receiving active medication) or comparator (COMP, 100% probability of receiving active medication) administration of antidepressant medication. Independent-samples t tests and analysis of covariance (ANCOVA) were used to determine whether the probability of receiving active medication influenced patient expectancy and to compare medication response in the PC v. COMP conditions. We also tested the correlations between baseline expectancy score and final improvement in depressive symptoms across study groups.
Subjects randomized to the COMP condition reported greater expectancy of improvement compared to subjects in the PC condition (t = 2.60, df = 27, p = 0.015). There were no statistically significant differences in the analyses comparing antidepressant outcomes between subjects receiving medication in the COMP condition and those receiving medication in the PC condition. Higher baseline expectancy of improvement was correlated with lower final depression severity scores (r = 0.53, p = 0.021) and greater improvement in depressive symptoms over the course of the study (r = 0.44, p = 0.058).
The methods described represent a promising way of subjecting patient expectancy to scientific study. Expectancy of improvement is affected by the probability of receiving active antidepressant medication and seems to influence antidepressant response.
本研究是一项随机、前瞻性研究，旨在探讨临床试验设计、患者期望与抗抑郁药物治疗结果之间的关系。方法：成年门诊患者被随机分为安慰剂对照（PC，50%概率接受活性药物）或比较（COMP，100%概率接受活性药物）组接受抗抑郁药物治疗。采用独立样本 t 检验和协方差分析（ANCOVA）来确定接受活性药物的概率是否影响患者的期望，并比较 PC 与 COMP 条件下的药物反应。我们还测试了基线期望得分与研究组之间抑郁症状最终改善之间的相关性。
与 PC 组相比，随机分配到 COMP 组的患者报告的改善期望更高（t=2.60，df=27，p=0.015）。在比较 COMP 组和 PC 组接受药物治疗的患者抗抑郁药疗效的分析中，没有统计学上的显著差异。较高的基线改善期望与较低的最终抑郁严重程度评分（r=0.53，p=0.021）和研究过程中抑郁症状的更大改善相关（r=0.44，p=0.058）。
所描述的方法代表了一种有前途的方法，可以使患者的期望受到科学研究的影响。改善的期望受到接受活性抗抑郁药物治疗的概率的影响，并且似乎会影响抗抑郁药的反应。
