Quitkin F M, Harrison W, Stewart J W, McGrath P J, Tricamo E, Ocepek-Welikson K, Rabkin J G, Wager S G, Nunes E, Klein D F
Department of Psychiatry, Columbia University, New York, NY.
Arch Gen Psychiatry. 1991 Apr;48(4):319-23. doi: 10.1001/archpsyc.1991.01810280035005.
We employed a study design that permitted a double-blind 12-week contrast of imipramine hydrochloride and phenelzine sulfate therapies in patients who met Columbia University criteria for atypical depression and were unresponsive to 7 weeks of treatment with placebo. These patients were found to benefit selectively from therapy with monoamine oxidase inhibitors compared with tricyclic drug therapy. This supports our observation about treatment response in depressed patients with reversed vegetative features. The design we utilized in this study has not previously been reported, to our knowledge. It was hypothesized that it would offer the advantage of the removal of a portion of placebo responders and serve to replicate our original findings. Treatment response to therapy with both imipramine and pheneizine in placebo nonresponders was uniformly lower (roughly 20% less than corresponding rates for patients who did not participate in the initial 6-week placebo trial). This is consistent with the view that the lower response rates were a result of the removal of some "placebo" responders in the drug groups. We think this is a useful design that should be considered in all studies of placebo and two active treatment regimens.
我们采用了一种研究设计，该设计允许对符合哥伦比亚大学非典型抑郁症标准且对7周安慰剂治疗无反应的患者进行为期12周的盐酸丙咪嗪和硫酸苯乙肼疗法的双盲对比。与三环类药物疗法相比，发现这些患者从单胺氧化酶抑制剂疗法中选择性获益。这支持了我们关于具有反向植物神经功能特征的抑郁症患者治疗反应的观察结果。据我们所知，我们在本研究中使用的设计以前尚未有过报道。据推测，它将具有去除一部分安慰剂反应者的优势，并有助于重复我们最初的发现。安慰剂无反应者对丙咪嗪和苯乙肼治疗的反应率均较低（大致比未参加初始6周安慰剂试验的患者相应比率低20%）。这与以下观点一致，即较低的反应率是由于药物组中一些“安慰剂”反应者被去除所致。我们认为这是一种有用的设计，在所有安慰剂和两种活性治疗方案的研究中都应予以考虑。
