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，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，缺乏坚持一致的药物治疗方案是许多患者长期的特征。不需要每日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才有。在美国，这些药物通常留给有不遵医嘱和反复复发史的患者。现在有一种长效的第二代（非典型）抗精神病药物——利培酮微球。一种既没有副作用负担，也没有与旧的长效药物相关的耻辱感的药物的可用性是精神分裂症治疗的一项重大进展。因此，评估第一批现有长效第二代药物的影响是及时的、创新的，具有相当大的公共卫生意义。随着我们这个领域的形成性发展，对于临床医生和患者来说，获得与第一代抗精神病药物的复发预防研究类似的独立于药物支持的复发预防信息将变得尤为重要。这8个站点的合作R01提出了一种有效的“现代”复发预防设计，长效第二代药物是否比口服第二代药物更有优势。340名同意的受试者将被随机分配到医生选择的口服药物或长效利培酮组，治疗长达两年半，并由蒙面评估员对精神病理学进行评估。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。所有患者将接受简短的心理教育干预，以提高治疗依从性。即使是相对适度的复发延迟和长期功能的改善，长期作用的第二代药物可能会转化为实质性的公共卫生效益。

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.