CLINICAL TRIAL: PREVENTING MORBIDITY IN FIRST EPISODE SCHIZOPHRENIA

临床试验：预防首发精神分裂症的发病

• 批准号: 7719265
• 负责人: DELBERT G ROBINSON
• 金额: $ 66.03万
• 依托单位: FEINSTEIN INSTITUTE FOR MEDICAL RESEARCH
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-04-22 至 2009-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7719265
• 关键词: Adverse effects; Antipsychotic Agents; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Deterioration; Disease; Double-Blind Method; Effectiveness; Ethnic group; Funding; Generations; Grant; Health; Institution; Metabolic; Morbidity - disease rate; Pharmaceutical Preparations; Population; Recruitment Activity; Research; Research Personnel; Resources; Risk; Risperidone; Schizophrenia; Source; Treatment outcome; United States National Institutes of Health; Week; Weight Gain; aripiprazole; first episode schizophrenia; inclusion criteria; olanzapine; prevent; social; trial comparing

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Studies with first episode populations offer the unique opportunity to examine the effectiveness and side effects of medications without the confounding effects of prior medication use. In addition, successful treatment of the initial psychotic episode is crucial for minimizing the cascading effects of social and vocational deterioration. Newer second generation antipsychotics with lower risks of weight gain and other metabolic side effects are now available, but little is known about their efficacy for first episode subjects, or their efficacy in comparison to risperidone or olanzapine. A crucial question is how much, if any, tradeoff in effectiveness would result if a low weight-gain second generation antipsychotic were used in place of a more widely used second generation antipsychotic. We propose a 12- week random-assignment, double-blind trial comparing risperidone with aripiprazole, a second-generation antipsychotic with a lower risk of metabolic side effects, as first treatment for subjects with schizophrenia spectrum disorders. In addition to the multi-dimensional assessment of treatment outcomes in our current study, the proposed study will feature a more comprehensive assessment of side effects with a focus upon metabolic and other side effects with important health consequences. To enhance generalizability of the findings, we will recruit subjects from settings serving diverse ethnic groups and use broad inclusion criteria.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目和 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 对首发人群的研究提供了独特的机会来检查药物的有效性和副作用，而不会混淆先前药物使用的影响。 此外，成功治疗最初的精神病发作对于最大限度地减少社会和职业恶化的连锁反应至关重要。 现在有更新的第二代抗精神病药物，其体重增加和其他代谢副作用风险较低，但人们对其对首发受试者的疗效或与利培酮或奥氮平相比的疗效知之甚少。 一个关键问题是，如果使用低体重增加的第二代抗精神病药代替更广泛使用的第二代抗精神病药，会在多大程度上（如果有的话）导致有效性的权衡。 我们提议进行一项为期 12 周的随机分配、双盲试验，比较利培酮与阿立哌唑（一种代谢副作用风险较低的第二代抗精神病药）作为精神分裂症谱系障碍受试者的首选治疗方法。除了我们当前研究中对治疗结果的多维评估之外，拟议的研究还将对副作用进行更全面的评估，重点关注代谢和其他具有重要健康后果的副作用。 为了增强研究结果的普遍性，我们将从服务于不同种族群体的环境中招募受试者，并使用广泛的纳入标准。