Janssen Scientific Affairs, LLC, Titusville, NJ, USA.
Int J Neuropsychopharmacol. 2012 Aug;15(7):1003-14. doi: 10.1017/S1461145711001738. Epub 2012 Jan 5.
The effect of placebo observed in schizophrenia clinical trials represents a growing problem that interferes with signal detection for treatments, increases costs of development, discourages investment in schizophrenia research and delays the introduction of new treatments. This paper seeks to clarify key issues related to this problem and identify potential solutions to them. Differences between placebo effect and response are characterized. Recent insights into the central nervous system mechanisms of placebo effect are described. This is followed by a description of protocol/study design and study conduct issues that are contributing to a growing placebo effect in clinical trials. Potential solutions to these problems are provided.
精神分裂症临床试验中观察到的安慰剂效应是一个日益严重的问题,它干扰了治疗效果的信号检测,增加了开发成本,阻碍了对精神分裂症研究的投资,并延迟了新治疗方法的引入。本文旨在澄清与这一问题相关的关键问题,并确定潜在的解决方案。对安慰剂效应和反应之间的差异进行了特征描述。描述了安慰剂效应的中枢神经系统机制的最新见解。接着描述了导致临床试验中安慰剂效应日益增强的方案/研究设计和研究实施问题。提供了对这些问题的潜在解决方案。