NEW ANTIPSYCHOTIC STRATEGIES IN SCHIZOPHRENIA

这是正在进行的一系列研究的竞争性延续， 测试新型抗精神病药物在精神抑制剂中的疗效和有效性 难治性精神分裂症患者 支持这一提议 我还将继续支持一个重要的公共和学术联络 马里兰州大学的治疗研究单位在 巴尔的摩。 在我们最初的工作中，我们已经开发了[艾德]一个标准的临床 测试候选药物在精神抑制剂中的不同作用的方案 难治性精神分裂症住院患者 这项研究提出， 应用将测试舍吲哚、喹替洛尔和 利培酮与氟奋乃静的比较 药物将 在药物-药物双盲平行组设计中进行测试。 这项研究将 过去24周 将选择抗精神病药物反应差的患者 由于至少一年的持续症状史， 对至少两个足够的精神抑制剂试验没有反应， 过去五年，全球经济表现不佳。 进入试验的患者也将未能对六次寻求做出回应 前瞻性氟哌啶醇治疗 目前的药物， 与奥氮平一起沿着研究，我们现在正在完成对奥氮平的评估， 代表了所有新的抗精神病药物， 近期 未来的候选药物将根据结果进行选择 这将是本审判的主题，并将成为今后提交的主题。 这种设计 为检验候选药物的优效性提供了有力的依据。 将分析BPRS总分改善的结果 和精神病症状 我们亦会评估 生活、生活技能和可出院性。 该研究规模基于 预测总症状差异为11%， 在阳性症状中，功效为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).