NEW ANTIPSYCHOTIC STRATEGIES IN SCHIZOPHRENIA

这是正在进行的一系列研究的竞争性延续 新型抗精神病药在抗精神病药中的疗效和疗效检验 难治性精神分裂症患者。支持这项提议 还将继续支持重要的公共和学术联系 马里兰大学治疗研究中心倡议 巴尔的摩。在我们最初的工作中，我们开发了一种标准的临床 测试候选药物在抗精神病药物中的不同效果的方案 难治性精神分裂症住院患者。在这项研究中提出的 应用程序将测试舍替多尔、奎硫平和 利培酮与氟奋乃静在该人群中的比较。毒品将会是 试验采用药物-药物双盲平行分组设计。这项研究将 过去的24周。抗精神病药物反应差的患者将被挑选出来 因为至少有一年的持续症状，病史 对至少两次足够的抗精神病药试验没有反应 过去五年和过去五年全球运作不佳。 参加试验的患者也将没有对六次请求做出反应 未来的氟哌啶醇疗法。目前的药物将是 与奥氮平一起研究，我们现在正在完成对其的评估， 代表所有新的抗精神病药物，将在 不久的将来。未来的候选药物将根据结果进行选择 并将作为未来提交材料的主题。这个设计 为测试候选药物的优越性提供了实质性的力量。 结果将根据BPRS总分的改善情况进行分析 和精神病症状。我们还将评估质量的改善情况 生活、生活技能和可放电性。这项研究的规模基于 总症状差异11%和差异22%的预测效果 在阳性症状中，幂为0.80，α为0.05(双尾)。

This is a competitive continuation of an on going series of studies to test the efficacy and effectiveness of novel antipsychotic in neuroleptic treatment resistant schizophrenic patients. Support for this proposal will also continue support for a significant Public and Academic Liaison initiative the Treatment Research Unit of the University of Maryland at Baltimore. In our initial work, we have develop[ed a standard clinical protocol to test candidate drugs for differential effect in neuroleptic treatment resistant schizophrenic inpatients. The study proposed in this application will test the efficacy of sertindole, quetiapine, and risperidone versus fluphenazine in this population. The drugs will be tested in a drug-drug double-blind parallel group design. The study will last 24-weeks. Patients will be selected for poor neuroleptic response because of a history of a least one year of persistent symptoms, a history of failure to respond to at least two adequate trials of neuroleptics over the past five years and poor global functioning for the past five years. Patients who enter the trial will also have failed to respond to six seeks of prospective haloperidol therapy. The current drugs that will be studied, along with olanzapine, whose evaluation we are completing now, represent all of the new antipsychotic drug that will be available in the near future. Future candidate drugs will be selected based on the outcome of this trial and will be the subject of future submissions. This design provides substantial power for testing superiority of a candidate drug. Results will be analyzed with regard to improvement in total BPRS score and psychotic symptoms. We will also assess improvements to quality of life, living skills and dischargability. This study size is based on a predicted effect of 11% difference in total symptoms and a 22% difference in positive symptoms with a power of 0.80 and alpha of 0.05 (two-tailed).