EFFECTIVENESS OF SWITCHING: CONVENTIONALS TO ATYPICALS

转换的有效性：常规药物到非典型药物在过去的几年里，新的，所谓的“非典型”抗精神病药物已经可用来治疗精神分裂症。奥氮平和利培酮是处方最广泛的两种抗精神病药物；这两种药物加起来占所有抗精神病药物处方的40%以上。鉴于它们的广泛使用，我们对这些新药物在常规实践环境中的有效性知之甚少。尽管非典型抗精神病药物已经出现了10年，但在美国，目前约有40%的抗精神病药物处方仍然使用传统药物。考虑到非典型抗精神病药物可能比传统药物更有效，副作用也更小，那么那些服用旧药物相对稳定但仍有症状或被药物副作用困扰的人是否应该改用非典型药物呢？这种药物转换的好处和风险是什么？共有300名精神分裂症患者同意从一个大型的，多样化的公共精神卫生系统，谁住在社区和服用传统的抗精神病药物，但仍然困扰的症状或药物的副作用，将被随机分配到继续使用他们目前的传统抗精神病药物（N=100）或切换到奥氮平（N=100）或利培酮（N=100）。这种设计特别控制了改变药物的过程，因为一组继续目前的治疗。因此，拟议的研究将评估从传统的非典型抗精神病药物转向一线抗精神病药物的增量风险和收益。所有的药物都是开放标签的，治疗将由研究参与者的常规提供者进行。研究参与者将被要求在指定的治疗条件下停留6个月，之后的药物决定将由患者和开处方的精神科医生决定。研究参与者将在基线和随访1年的间隔时间内接受定量访谈，以确定临床病程和使用的服务类型。该研究将确定从传统的非典型抗精神病药物切换到最常用的非典型抗精神病药物的增量风险和收益，以及切换到奥氮平与切换到利培酮的相对风险和收益。

Effectiveness of Switching: Conventionals to Atypicals Over the past several years, new, so-called "atypical," antipsychotic medications have become available to treat schizophrenia. Olanzapine and risperidone are the two most widely prescribed antipsychotics; together they account for over 40 percent of all antipsychotic prescriptions. Given their wide usage, we know surprisingly little about the effectiveness of these newer medications in routine practice settings. Despite a decade of availability of atypical antipsychotics, about 40 percent of the antipsychotic prescriptions filled in the United States today are still for conventional agents. Given that the atypical antipsychotics may be more effective than the conventional ones and have less burdensome side effects, should people who are relatively stable on the older medications but who are still symptomatic or troubled by medication side effects be switched to an atypical medication? What are the benefits and risks associated with such medication switches? A total of 300 consenting patients with schizophrenia from a large, diverse public mental health system, who are living in the community and taking conventional antipsychotic medications but who are still troubled by symptoms or medication side effects, will be randomly assigned to stay on their current conventional antipsychotic medication (N =100) or to switch to olanzapine (N =100) or risperidone (N=100). This design specifically controls for process of changing medications because one group continues on current treatment. The proposed study, therefore, will assess what incremental risks and benefits can be expected from switching from a conventional to a first-line atypical antipsychotic agent. All medications will be open label, and treatment will be by the study participants' routine providers. Study participants will be asked to stay in their assigned treatment condition for 6 months, after which time medication decisions will be up to the patient and the prescribing psychiatrist. Study participants will be interviewed with quantitative instruments at baseline and at follow-up intervals for 1 year to determine clinical course and the types of services used. The study will determine the incremental risks and benefits of switching from a conventional to the most commonly prescribed atypical antipsychotics, and the relative risks and benefits of switching to olanzapine versus switching to risperidone.