Relapse Prevention: Long-Acting Atypical Antipsychotics

预防复发：长效非典型抗精神病药

• 批准号: 6928200
• 负责人: STEPHEN R MARDER
• 金额: $ 31.19万
• 依托单位: UNIVERSITY OF CALIFORNIA LOS ANGELES
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-02-01 至 2010-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6928200
• 关键词: antipsychotic agents; behavioral /social science research tag; clinical research; clinical trials; cooperative study; disease /disorder prevention /control; drug adverse effect; functional ability; hospital utilization; human subject; human therapy evaluation; injection /infusion; interview; longitudinal human study; mental disorder chemotherapy; mental health education; mood disorders; oral administration; patient oriented research; psychopharmacology; relapse /recurrence; risperidone; slow release drug

DESCRIPTION (provided by applicant): Treatment of schizophrenia requires long-term interventions that address the range of problems that the illness generates. Continuous receipt of antipsychotic medication is the bedrock on which all other interventions for schizophrenia rest and lack of adherence to a consistent medication regimen characterizes many patients over the long-term. The potential benefits of long acting medication that does not require daily self administration has only been available with first generation antipsychotics. In the United States, these medications have generally been reserved for patients who have demonstrated histories of non-compliance and repeated relapse. There is now a long acting form of one of the second-generation ('atypical') antipsychotics - risperidone microspheres. The availability of a medication that does not share either the side effect burden or the stigma associated with old long acting medications represents a major development in the treatment of schizophrenia. Evaluating the impact of the first available long-acting second-generation is therefore timely, innovative, and of considerable public health significance. With such a formative development for our field, it will be particularly important for clinicians and patients alike to acquire information on relapse prevention that is independent of pharmaceutical support in a manner comparable to prior relapse prevention studies of first generation antipsychotic medications. This eight site collaborative R01 proposes to investigate in an effectiveness, "modern-day" relapse prevention design, whether a long acting second generation medication offers advantages compared to oral second-generation medication. Three hundred four consenting subjects will be randomized to physician's choice oral medication or long acting risperidone, treated for up to two and a half years, and evaluated by masked assessors on measures of psychopathology. Data to be collected will also include time to relapse, level of functioning, service utilization, and medication tolerability. All patients will receive a brief psychoeducational intervention designed to enhance treatment adherence. Even relatively modest delays in relapse and improvement of long term functioning potentially resulting from a long acting second-generation medication can translate into substantial public health benefits.

描述（由申请人提供）：精神分裂症的治疗需要长期干预，以解决疾病产生的一系列问题。持续接受抗精神病药物是所有其他精神分裂症干预措施的基础，而长期缺乏坚持一致的药物治疗方案是许多患者的特点。不需要每天自行给药的长效药物的潜在益处仅适用于第一代抗精神病药物。在美国，这些药物通常只用于有不依从性和反复复发史的患者。现在有第二代（“非典型”）抗精神病药物之一的长效形式——利培酮微球。一种既不带来副作用负担，又不带来与旧的长效药物相关的耻辱的药物的出现，代表了精神分裂症治疗的重大进展。因此，评估第一个可用的长效第二代药物的影响是及时的、创新的，并且具有相当大的公共卫生意义。随着我们领域的如此形成性发展，对于临床医生和患者来说，以与第一代抗精神病药物的先前复发预防研究相当的方式获取独立于药物支持的复发预防信息将尤为重要。这个八站点协作 R01 提议以有效的“现代”复发预防设计来研究长效第二代药物与口服第二代药物相比是否具有优势。三百四名同意的受试者将被随机分配接受医生选择的口服药物或长效利培酮治疗，治疗时间长达两年半，并由蒙面评估员进行精神病理学测量评估。收集的数据还包括复发时间、功能水平、服务利用率和药物耐受性。所有患者都将接受简短的心理教育干预，旨在提高治疗依从性。即使长效第二代药物可能导致相对适度的复发延迟和长期功能改善，也可以转化为巨大的公共健康益处。