1 University Department of Psychiatry, University of Southampton, Southampton, UK.
2 Psychopharmacology and Emotion Research Laboratory, Department of Psychiatry, University of Oxford, Oxford, UK.
J Psychopharmacol. 2017 Dec;31(12):1578-1587. doi: 10.1177/0269881117739552.
Placebo-controlled trials are the gold standard measure of efficacy in the development of new treatments for depression. However, the large placebo effects associated with standard measures of subjective symptoms reduce the sensitivity of such trials to detect antidepressant effects. There is a need to develop novel efficacy markers that are resistant to placebo effects. Measures of emotional processing, known to be sensitive to antidepressant treatment, may be such a marker, although the effect of an acute placebo treatment on these measures remains unclear. We assessed the influence of placebo on a validated battery of emotional processing tasks, the Emotional Test Battery (ETB), in healthy participants. Participants were informed they might receive the antidepressant drug bupropion, placebo or no treatment, with placebo effect being estimated as the difference between the placebo and no treatment groups. We found no significant difference between these groups on measures of emotional processing. There was also no effect of subjective treatment expectancy on performance in the tasks. This suggests that the ETB might be a useful tool for Phase I trials assessing novel antidepressant agents against placebo.
安慰剂对照试验是评估新的抑郁症治疗方法疗效的金标准。然而，与主观症状的标准测量相关的大的安慰剂效应降低了这些试验检测抗抑郁作用的敏感性。因此需要开发对安慰剂效应具有抗性的新型疗效标志物。已知对情绪处理敏感的措施可能就是这样的一个标志物，尽管急性安慰剂治疗对这些措施的影响尚不清楚。我们评估了安慰剂对健康参与者的经过验证的情绪处理任务电池，即情绪测试电池（ETB）的影响。参与者被告知他们可能会接受抗抑郁药物安非他酮、安慰剂或不治疗，安慰剂效应估计为安慰剂和不治疗组之间的差异。我们发现这些组之间在情绪处理测量上没有显著差异。任务表现也没有受到主观治疗预期的影响。这表明 ETB 可能是评估新型抗抑郁药与安慰剂相比的 I 期试验的有用工具。
