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

2/2-A 治疗精神分裂症的长效注射药物的比较 -ACLAIMS

• 批准号: 7882587
• 负责人: THOMAS SCOTT STROUP
• 金额: $ 300.82万
• 依托单位: COLUMBIA UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-07-09 至 2014-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7882587
• 关键词: Academic Medical Centers; Address; Adherence; Adverse effects; Adverse event; Agreement; Anti-Cholinergics; Antipsychotic Agents; Blinded; Cardiovascular Diseases; Clinical; Clinical Trials; Clinical Trials Data Monitoring Committees; Clinical Trials Design; Clinical assessments; Collaborations; Contracts; Data; Data Analyses; Data Quality; Databases; Doctor of Medicine; Doctor of Philosophy; Dose; Double-Blind Method; Effectiveness; Effectiveness of Interventions; Elements; Ensure; Fasting; Fluphenazine; Foundations; Funding; Generic Drugs; Glucose; Goals; Grant; Health system; High Prevalence; Hospitalization; Incidence; Individual; Injectable; Institution; Insulin; Intervention Studies; Intervention Trial; Investigation; Lead; Leadership; Lipids; Manuscripts; Marketing; Measurement; Measures; Mental Health; Metabolic; Methods; Microspheres; Monitor; Mood Disorders; National Institute of Mental Health; North Carolina; Office of Administrative Management; Oral; Outcome Measure; Palmitates; Parkinson Disease; Patients; Persons; Pharmaceutical Preparations; Phase; Policy Maker; Preparation; Price; Principal Investigator; Procedures; Prolactin; Protocols documentation; Psychopathology; Public Health; Quality-Adjusted Life Years; Randomized; Recruitment Activity; Regimen; Relapse; Relative (related person); Reporting; Research; Research Design; Research Infrastructure; Research Personnel; Research Project Grants; Research Proposals; Risk; Risperidone; Sample Size; Sampling; Schizoaffective Disorders; Schizophrenia; Secondary to; Serious Adverse Event; Services; Severities; Site; System; Tardive Dyskinesia; Teleconferences; Texas; Time; Training; United States National Institutes of Health; Universities; Vendor; Visit; Weight Gain; Work; atypical antipsychotic; base; clinical practice; clinical research site; compare effectiveness; cost; cost effective; cost effectiveness; data management; design; effectiveness research; experience; fasting glucose; fluphenazine depot; high risk; implementation trial; improved; meetings; multi-site trial; olanzapine; operation; payment; primary outcome; public health relevance; public health research; research study; service utilization; therapeutic effectiveness; trial comparing

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.

描述（由申请人提供）：关注市场营销，而不是证据，驱动临床实践。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新型非典型抗精神病药物实现的市场饱和提供支持。一种长效可注射（LAI）非典型抗精神病药物利培酮微球（RM）目前的平均批发价格为每位患者每年约8,000美元，高于通用常规LAI制剂（例如，癸酸氟奋乃静- FD）。没有进行比较RM和FD的研究来证明这种溢价定价的合理性。另外两种非典型LAI制剂（双羟萘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的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患者将被随机分配接受长达42个月的RM或限制剂量FD盲态治疗。本试验的主要结局指标是复发时间。在整个试验期间，将对服务利用、精神病理学和不良事件进行重复评估。在整个试验期间，将定期采集空腹样本，用于测量葡萄糖、胰岛素、血脂和催乳素。该试验将利用NIMH的基础设施，包括其行政和实施单位以及数据管理和分析单位。该试验将在25个临床试验机构进行，代表了广泛的临床环境，以生成可概括和实用相关的信息。该办公室将提供全面监督，以确保试验的成功实施，包括快速启动程序和实施，实时监测高质量数据，以及高效的数据分析和手稿编写。ACLAIMS项目叙述性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情感障碍患者治疗的一致性。本研究将比较一种新的长效制剂（利培酮微球）和一种较老的长效制剂，后者每年的费用约为8,000美元，我们将确定新制剂是否能使患者在更长的时间内免于精神病复发。 公共卫生相关性：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情感障碍患者治疗的一致性。本研究将比较一种新的长效制剂（利培酮微球）和一种较老的长效制剂，后者每年的费用约为8,000美元，我们将确定新制剂是否能使患者在更长的时间内免于精神病复发。