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: 8167220
• 负责人: DELBERT G ROBINSON
• 金额: $ 67.63万
• 依托单位: FEINSTEIN INSTITUTE FOR MEDICAL RESEARCH
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-04-01 至 2011-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8167220
• 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; 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. 0119 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.

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 0119 第一集人群的研究为检查药物的有效性和副作用提供了独特的机会，而没有先前使用药物的混淆作用。 此外，最初的精神病发作的成功治疗对于最大程度地减少了社会和职业恶化的级联影响至关重要。 现在可以使用具有较低风险和其他代谢副作用的新的第二代抗精神病药，但与利培酮或奥氮平相比，它们对第一事件的功效或其功效知之甚少。 一个至关重要的问题是，如果使用低体重的第二代抗精神病药代替使用更广泛使用的第二代抗精神病药，那么有效性将产生多少（如果有的话）。 我们提出了一项为期12周的随机分配，双盲试验，将利培酮与阿立哌唑（一种第二代抗精神病药）进行了比较，其代谢副作用的风险较低，作为对精神分裂症谱系疾病的受试者的首次治疗。除了在我们当前的研究中对治疗结果的多维评估外，拟议的研究还将对副作用进行更全面的评估，重点是代谢和其他副作用，具有重要的健康后果。 为了提高调查结果的普遍性，我们将从为各种族裔群体的环境中招募主题，并使用广泛的包容标准。