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: 8018897
• 负责人: THOMAS SCOTT STROUP
• 金额: $ 155.28万
• 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/8018897
• 关键词: Academic Medical Centers; Address; Adherence; Adverse effects; Adverse event; Agreement; Anti-Cholinergics; Antipsychotic Agents; Award; Belief; Blinded; Blood specimen; 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; Drug Costs; Effectiveness; Effectiveness of Interventions; Elements; Ensure; Fasting; Fluphenazine; Foundations; Funding; Glucose; Goals; Grant; Health system; High Prevalence; Hospitalization; Impaired cognition; Incidence; Individual; Injectable; Institution; Insulin; Intervention Studies; Intervention Trial; Investigation; Lead; Leadership; Lipids; Manuscripts; Measurement; Measures; Mental Health; Metabolic; Methods; Microspheres; Monitor; Mood Disorders; National Institute of Mental Health; North Carolina; Office of Administrative Management; Operative Surgical Procedures; Oral; Outcome Measure; Parkinson Disease; Patients; Persons; Pharmaceutical Preparations; Phase; Policy Maker; Preparation; Principal Investigator; Procedures; Prolactin; Protocols documentation; Psychopathology; Public Health; Quality of life; Quality-Adjusted Life Years; Randomized; Relapse; Relative (related person); Reporting; Research; Research Design; Research Infrastructure; Research Personnel; Research Project Grants; Research Proposals; Resources; Risk; Risperidone; Sample Size; Schizoaffective Disorders; Schizophrenia; Secondary to; Serious Adverse Event; Services; Severities; Site; System; Tardive Dyskinesia; Teleconferences; Testing; Time; Training; Treatment Protocols; United States National Institutes of Health; Universities; Vendor; Visit; Weight Gain; Work; base; clinical practice; clinical research site; compare effectiveness; cost; cost effective; cost effectiveness; data management; design; effectiveness research; experience; fasting glucose; fluphenazine depot; follow-up; high risk; implementation trial; improved; meetings; multi-site trial; neuropsychological; payment; primary outcome; 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）：人们越来越担心，推动临床实践的是营销，而不是证据。昂贵的新药的使用常常远远超出其既定价值。最近对口服抗精神病药物进行的独立、客观的比较几乎没有为新型非典型抗精神病药物所实现的市场饱和提供支持。利培酮微球 (RM) 是一种长效注射 (LAI) 非典型抗精神病药物，目前的平均批发价格约为每名患者每年 8,000 美元，比通用的传统 LAI 制剂（例如氟奋乃静癸酸酯 - FD）高出约 8,000 美元。尚未进行过比较 RM 和 FD 的研究来证明这种溢价的合理性。另外两种非典型 LAI 制剂（双羟萘酸奥氮平和棕榈酸帕潘立酮）可能会在明年上市，我们预计这些新药的积极营销将大大增加 LAI 抗精神病药物的使用。本研究的目的是比较 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。三百六十 (360) 名 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 盲法治疗。该试验的主要结果指标是复发时间。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葡萄糖、胰岛素、血脂和催乳素的空腹样本。该试验将利用 NIMH STN 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 STN 站点进行，代表广泛的临床环境，以生成可推广且实用的相关信息。 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、高效的数据分析和稿件准备。声明项目叙述每两周注射一次的长效抗精神病药物制剂可以提高精神分裂症或分裂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）和一种每年花费约 8,000 美元的旧长效制剂。我们将确定新制剂是否可以使患者在更长的时间内免于精神病复发。 公共卫生相关性：每两周注射一次的长效抗精神病药物制剂可以提高精神分裂症或分裂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）和一种每年花费约 8,000 美元的旧长效制剂。我们将确定新制剂是否可以使患者在更长的时间内免于精神病复发。