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: 8449708
• 负责人: MARVIN S SWARTZ
• 金额: $ 31.12万
• 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 2016-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8449708
• 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.

担心营销而不是证据推动了临床实践。使用昂贵的新 药物通常远远超出其既定价值。最近独立的客观比较 口服抗精神病药剂几乎没有为新的饱和度提供的支持 非典型抗精神病药物。一种长效注射（LAI）非典型抗精神病药， 利培酮微球（RM）目前以平均批发价格提供 每年每年$ 8,000高于通用的LAI准备工作（例如，Fluphenazine decanoate- fd）。没有进行比较RM和FD的研究，以证明这种高级定价是合理的。另外两个 非典型LAI制剂（奥氮平帕莫特和帕利培酮棕榈酸酯）可以在 来年，我们可以预期，这些新药的积极营销将增加LAI的使用 抗精神病药很大。 拟议研究的目的是比较RM和 精神分裂症或精神分裂症患者（SCH/SCHAFF）患者的剂量FD受限剂量FD。核心目的 精神分裂症试验网络（STN）是为临床医生和政策制定者提供独立的， 用于治疗精神分裂症患者的药物的客观比较。 三百六十（360）例SCH/SHAFF患者将被随机分配到42个月 用RM或受限剂量FD治疗。该试验的主要结果度量将是时间 复发。将重复评估服务利用，心理病理学和不良事件 在整个审判中。将获得用于测量葡萄糖，胰岛素，脂质和催乳素的禁食样品 在整个试验期间定期进行时间间隔。 该试验将利用NIMH STN基础架构，包括其行政和实施单位，以及 数据管理和分析单元。该试验将在25个STN站点进行，代表一个广泛的阵列 临床环境的产生概括性和务实相关的信息。 STN将提供 全面的监督以确保成功实施试验，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以及 手稿准备。