2/2-A Comparison of Long-Acting Injectable Medications for Schizophrenia -ACLAIMS

描述（由申请人提供）：人们已经开始关注驱动临床实践的是市场营销，而不是证据。昂贵的新药的使用往往远远超出其既定价值。最近独立的、客观的口服抗精神病药物的比较并没有为新的非典型抗精神病药物达到市场饱和提供支持。一种长效注射（LAI）非典型抗精神病药物利培酮微球（RM）目前的平均批发价约为每位患者每年8,000美元，高于非专利常规LAI制剂（例如癸酸氟非那嗪- FD）。没有研究对RM和FD进行比较，证明这种溢价定价是合理的。另外两种非典型LAI制剂（帕马酸奥氮平和棕榈酸帕利哌酮）可能在未来一年内上市，我们可以预期这些新药的积极营销将大大增加LAI抗精神病药物的使用。拟议研究的目的是比较RM和限制剂量FD在精神分裂症或精神分裂情感性障碍（SCH/SCHAFF）患者中的有效性、成本和耐受性。精神分裂症试验网络（STN）的一个核心目的是为临床医生和政策制定者提供用于治疗精神分裂症患者的药物的独立、客观的比较。360例SCH/SCHAFF患者将被随机分配到长达42个月的盲法治疗，使用RM或限制剂量FD。该试验的主要结局指标是复发时间。在整个试验过程中，将对服务利用、精神病理和不良事件进行反复评估。在整个试验过程中，将定期获得用于测量葡萄糖、胰岛素、脂质和催乳素的空腹样品。该试验将利用NIMH STN基础设施，包括其行政和实施单元，以及数据管理和分析单元。该试验将在25个STN站点进行，代表了广泛的临床环境，以产生可推广和实用相关的信息。STN将提供全面的监督，以确保试验的成功实施，包括快速启动程序和实施，高质量数据的实时监控，以及有效的数据分析和手稿准备。抗精神病药物的长效制剂，每2周注射一次，可以提高精神分裂症或精神分裂情感性障碍患者治疗的一致性。这项研究将比较一种新的长效制剂（利培酮微球）和一种较旧的长效制剂，后者每年的成本约为8000美元。我们将确定新的制剂是否能使患者在更长的时间内免于精神病复发。

DESCRIPTION (provided by applicant): Concern has developed that marketing, not evidence, drives clinical practice. The use of expensive new medications often extends well beyond their established value. Recent independent, objective comparisons of oral antipsychotic preparations have provided little support for the market saturation achieved by the newer atypical antipsychotic medications. One long-acting injectable (LAI) atypical antipsychotic medication, risperidone microspheres (RM) is currently available at an average wholesale price that is approximately $8,000 per patient per year higher than generic conventional LAI preparations (e.g., fluphenazine decanoate-- FD). No study comparing RM and FD has been conducted that justifies this premium pricing. Two additional atypical LAI preparations (olanzapine pamoate and paliperidone palmitate) may become available within the coming year, and we can expect that aggressive marketing of these new drugs will increase the use of LAI antipsychotics considerably. The objective of the proposed research is to compare the effectiveness, costs, and tolerability of RM and restricted dose FD in patients with schizophrenia or schizo-affective disorder (SCH/SCHAFF). A core purpose of the Schizophrenia Trials Network (STN) is to provide, for clinicians and policy makers, independent, objective comparisons of medications used to treat patients with schizophrenia. Three hundred and sixty (360) patients with SCH/SCHAFF will be randomly assigned to up to 42 months of blinded treatment with either RM or restricted dose FD. The primary outcome measure for this trial will be time to relapse. Repeated assessments of service utilization, psychopathology, and adverse events will be made throughout the trial. Fasting samples for measurement of glucose, insulin, lipids, and prolactin will be obtained at regular intervals throughout the trial. The trial will utilize the NIMH STN infrastructure, including its Administrative and Implementation Units, and Data Management and Analysis Units. The trial will be conducted at 25 STN sites, representing a broad array of clinical settings to generate generalize-able and pragmatically relevant information. The STN will provide comprehensive oversight to ensure the successful implementation of the trial, including rapid start-up procedures and implementation, real-time monitoring for high quality data, and efficient data analysis and manuscript preparation. ACLAIMS PROJECT NARRATIVE Long-acting preparations of antipsychotic medications, injected every 2 weeks, may improve the consistency of treatment for patients with schizophrenia or schizo-affective disorder. This study will compare a new long- acting preparation (risperidone microspheres) with an older long-acting preparation that costs approximately $8,000 per year less. We will determine if the new preparation keeps patients free of psychotic relapse for a significantly longer time. PUBLIC HEALTH RELEVANCE: Long-acting preparations of antipsychotic medications, injected every 2 weeks, may improve the consistency of treatment for patients with schizophrenia or schizo-affective disorder. This study will compare a new long- acting preparation (risperidone microspheres) with an older long-acting preparation that costs approximately $8,000 per year less. We will determine if the new preparation keeps patients free of psychotic relapse for a significantly longer time.