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的干预，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所有其他精神分裂症干预措施的基础，长期而言，许多患者的特点是休息和不遵守一致的药物治疗方案。长效药物的潜在好处是不需要每天自我给药，只有第一代抗精神病药物才能获得。在美国，这些药物通常是为有不依从病史和反复复发的患者保留的。现在有一种第二代(非典型)抗精神病药物之一的长效形式-利培酮微球。一种既不会分担副作用负担，也不会受到与旧的长效药物相关的耻辱的药物的出现，代表着精神分裂症治疗方面的一项重大进展。因此，评估第一个可用的长效第二代疫苗的影响是及时的、具有创新性的，并具有相当大的公共卫生意义。随着我们这个领域的形成发展，对于临床医生和患者来说，以一种可与先前的第一代抗精神病药物的复发预防研究相媲美的方式，获得独立于药物支持的关于复发预防的信息将尤为重要。这八个站点合作的R01建议调查在一个有效的，“现代”的复发预防设计中，长效第二代药物是否提供比口服第二代药物更多的优势。三百零四名同意的受试者将被随机分为医生选择的口服药物或长效利培酮，治疗时间长达两年半，并由蒙面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。所有患者都将接受简短的心理教育干预，旨在提高治疗依从性。即使是长效第二代药物可能导致的复发和长期功能改善的相对适度的延迟，也可以转化为重大的公共卫生好处。

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.