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

描述(由申请人提供)：市场营销，而不是证据，推动了临床实践。昂贵的新药的使用往往远远超出其既定的价值。最近对口服抗精神病药物制剂进行的独立、客观的比较，几乎没有为较新的非典型抗精神病药物实现的市场饱和提供支持。作为一种长效注射(LAI)非典型抗精神病药物，利培酮微球(RM)目前的平均批发价比一般的传统LAI制剂(例如，氟奋乃静癸酸盐--FD)高出每位患者每年约8000美元。还没有对RM和FD进行比较的研究来证明这种溢价是合理的。另外两种非典型的LAI制剂(帕甲酸奥氮平和帕利哌酮棕榈酸酯)可能在来年上市，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在精神分裂症或分裂情感障碍(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、客观比较。360名SCH/SCHIFF患者将被随机分配到使用RM或限制剂量的FD进行长达42个月的盲目治疗。这项试验的主要结果衡量标准将是复发时间。在整个试验过程中，将对服务利用率、精神病理学和不良事件进行反复评估。在整个试验过程中，将定期采集用于测量血糖、胰岛素、血脂和催乳素的空腹样本。审判将利用NIMH STN基础设施，包括其行政和执行单位以及数据管理和分析单位。这项试验将在25个STN站点进行，代表了一系列广泛的临床环境，以产生可推广和实用的相关信息。STN将提供全面监督，以确保试验的成功实施，包括快速启动程序和实施、对高质量数据的实时监测以及高效的数据分析和手稿准备。ACLAIMS项目叙事抗精神病药物的长效制剂，每两周注射一次，可能会提高精神分裂症或分裂情感障碍患者的治疗一致性。这项研究将对一种新的长效制剂(利培酮微球)和一种较旧的长效制剂进行比较，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避免精神病复发。 公共卫生相关性：抗精神病药物的长效制剂，每两周注射一次，可能会提高精神分裂症或分裂情感障碍患者的治疗一致性。这项研究将对一种新的长效制剂(利培酮微球)和一种较旧的长效制剂进行比较，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避免精神病复发。

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.