1/2-A Comparison of Long-Acting Injectable Medications for Schizophrenia -ACLAIMS

1/2-A 精神分裂症长效注射药物的比较 -ACLAIMS

• 批准号: 8323934
• 负责人: Joseph Patrick McEvoy
• 金额: $ 32.33万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-07-01 至 2014-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8323934
• 关键词: Academic Medical Centers; Address; Adherence; Adverse effects; Adverse event; Anti-Cholinergics; Antipsychotic Agents; Blinded; Cardiovascular Diseases; Clinical; Clinical Trials; Contracts; Data Analyses; Data Quality; Dose; Double-Blind Method; Effectiveness; Effectiveness of Interventions; Elements; Ensure; Fasting; Funding; Generic Drugs; Glucose; Goals; Health system; High Prevalence; Hospitalization; Incidence; Individual; Injectable; Institution; Insulin; Intervention Studies; Intervention Trial; Investigation; Lead; Leadership; Lipids; Manuscripts; Marketing; Measurement; Measures; Mental Health; Methods; Microspheres; Monitor; Mood Disorders; National Institute of Mental Health; North Carolina; 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); Research; Research Design; Research Infrastructure; Research Methodology; Research Personnel; Research Project Grants; Research Proposals; Risk; Risperidone; Sample Size; Sampling; Schizoaffective Disorders; Schizophrenia; Secondary to; Severities; Site; Tardive Dyskinesia; Texas; Time; United States National Institutes of Health; Universities; Weight Gain; Work; atypical antipsychotic; base; clinical practice; clinical research site; compare effectiveness; cost; cost effective; cost effectiveness; data management; experience; fasting glucose; fluphenazine depot; high risk; implementation trial; improved; meetings; olanzapine; operation; primary outcome; research study; service utilization; therapeutic effectiveness; trial comparing

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.

人们越来越担心，推动临床实践的是营销，而不是证据。使用昂贵的新 药物的使用往往远远超出其既定的价值。最近的独立，客观的比较 口服抗精神病药物制剂几乎没有为较新的抗精神病药物达到的市场饱和提供支持， 非典型抗精神病药物一种长效注射（LAI）非典型抗精神病药物， 利培酮微球（RM）目前可以以大约1000克的平均批发价格获得。 每名患者每年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。两个附加 非典型LAI制剂（双羟萘酸奥氮平和棕榈酸帕潘立酮）可能在 我们可以预期，这些新药的积极营销将增加LAI的使用 抗精神病药物相当多。 这项研究的目的是比较RM和 精神分裂症或情感障碍（SCH/SCHAFF）患者的限制剂量FD。核心目的 精神分裂症试验网络（Schizophrenia Trials Network）的目标是为临床医生和政策制定者提供独立的， 精神分裂症患者治疗药物的客观比较。 360例SCH/SCHAFF患者将被随机分配至长达42个月的 用RM或限制剂量FD进行盲法治疗。本试验的主要结局指标是时间 复发将对服务利用、精神病理学和不良事件进行重复评估 在整个审判过程中。将采集空腹样本，用于测量葡萄糖、胰岛素、脂质和催乳素 在整个审判过程中定期进行。 该试验将利用NIMH的基础设施，包括其行政和执行单位， 数据管理和分析股。该试验将在25个研究中心进行， 以生成可概括的实用相关信息。STN将提供 全面监督，以确保审判的成功实施，包括快速启动 高质量数据的实时监控，以及高效的数据分析， 手稿准备。