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首页> 外文期刊>The journal of clinical psychiatry >Determinants of antipsychotic response in schizophrenia: Implications for practice and future clinical trials
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Determinants of antipsychotic response in schizophrenia: Implications for practice and future clinical trials

机译：精神分裂症抗精神病药物反应的决定因素：对实践和未来临床试验的影响

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Background: Response to antipsychotics in schizophrenia is highly variable, and determinants are not well understood or used to design clinical trials. Objective: We aimed to understand determinants of response to antipsychotic treatment. Method: Supported by the Innovative Medicines Initiative, as part of a large public-private collaboration (NEWMEDS), we assembled the largest dataset of individual patient level information from randomized placebo-controlled trials of second-generation antipsychotics cond ucted in ad ult schizophrenia patients by5 large pharmaceutical companies.The dataset included all placebo-controlled trials of risperidone, paliperidone, ziprasidone, sertindole, olanzapine, and quetiapine. We examined patient- and trial-design related determinants of outcome as measured by change on the Positive and Negative Syndrome Scale in 29 placebo-controlled trials (drug, n 6,971; placebo, n 2,200) and initial findings confirmed in additional data from 5 separate trials (drug, n 1,699; placebo, n 580). Results: While it is conventional for trials to be 6 weeks long, drug-placebo differences were observable at week 4 with nearly the same sensitivity, and dropout rates were lower. Having any of these attributes was associated with significantly greater drug versus placebo differences in symptom improvement and rates of study completion: being female (P <.04), being a young adult patient who is a few years beyond the first episode (P <.03), having prominent positive and negative symptoms (P<.03), and living in Eastern Europe versus North America (P <.04). Contrary to prevalent clinical opinion, age at onset and use of benzodiazepines did not show a differential treatment response, and patients just above PANSS inclusion threshold were not overrepresented. Conclusions: Proof-of-concept trials can be shorter and efficiency improved by including an even distribution of sexes and of patients with prominent symptomatology, thus reducing patient exposure to placebo and experimental treatments.
机译：背景：精神分裂症患者对抗精神病药的反应差异很大，决定因素尚未得到很好的理解或用于设计临床试验。目的：我们旨在了解抗精神病药物治疗反应的决定因素。方法：在创新药物计划的支持下，作为大型公私合作（NEWMEDS）的一部分，我们从成人精神分裂症患者接受的第二代抗精神病药的随机安慰剂对照试验中收集了最大的个体患者水平信息数据集由5家大型制药公司组成。数据集包括利培酮，帕潘立酮，齐拉西酮，塞地多尔，奥氮平和喹硫平的所有安慰剂对照试验。我们在29项安慰剂对照试验（药物，n 6,971;安慰剂，n 2,200）中检查了患者和试验设计相关结果的决定因素，这些因素是通过阳性和阴性综合征量表的变化来衡量的，并且在另外5个单独的数据中证实了最初的发现试验（药物，n 1,699;安慰剂，n 580）。结果：虽然通常需要6周的时间进行试验，但在第4周观察到药物-安慰剂差异却具有几乎相同的敏感性，且辍学率较低。具有这些属性中的任何一个与症状改善和研究完成率的药物和安慰剂差异明显更大有关：女性（P <.04），是年轻成人患者，距首次发作数年后（P <。 03），具有明显的阳性和阴性症状（P <.03），并且居住在东欧与北美之间（P <.04）。与流行的临床观点相反，苯二氮卓类药物的发病年龄和使用并未显示出不同的治疗反应，并且刚好超过PANSS纳入阈值的患者也没有过多代表。结论：通过使性别和具有明显症状的患者均匀分布，可以缩短概念验证试验并提高效率，从而减少患者接受安慰剂和实验治疗的时间。

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