Relapse Prevention: Long-Acting Atypical Antipsychotics

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治疗是精神分裂症所有其他干预措施的基础，长期以来，许多患者缺乏对一致药物治疗方案的依从性。不需要每天自我给药的长效药物的潜在益处仅在第一代抗精神病药物中可用。在美国，这些药物通常保留给那些有不依从和反复复发病史的患者。现在有一种长效形式的第二代（“非典型”）抗精神病药-利培酮微球。一种药物的可用性，既不分享与旧的长效药物相关的副作用负担或耻辱，代表了精神分裂症治疗的一个重大发展。因此，评估第一个长效第二代的影响是及时的，创新的，具有相当大的公共卫生意义。随着我们这一领域的形成性发展，临床医生和患者获得与第一代抗精神病药物的既往复发预防研究相当的独立于药物支持的复发预防信息将特别重要。这八个网站的合作R 01建议调查的有效性，“现代”复发预防设计，是否长效第二代药物提供的优势相比，口服第二代药物。304例知情同意的受试者将随机接受医生选择的口服药物或长效利培酮，治疗长达两年半，并由设盲评估员对精神病理学指标进行评估。收集的数据还将包括复发时间、功能水平、服务利用率和药物耐受性。所有患者将接受简短的心理教育干预，旨在提高治疗依从性。即使是相对温和的延迟复发和改善长期功能可能导致长效第二代药物可以转化为重大的公共卫生效益。

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.