EFFECTIVENESS OF SWITCHING: CONVENTIONALS TO ATYPICALS

转换的有效性：从常规到非典型

• 批准号: 6664248
• 负责人: Susan M Essock
• 金额: $ 54.41万
• 依托单位: ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-07-01 至 2004-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6664248
• 关键词: clinical trials; clozapine; decision making; drug adverse effect; haloperidol; human subject; human therapy evaluation; mental disorder chemotherapy; patient care management; patient oriented research; risperidone; schizophrenia; serotonin inhibitor

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.

转换的有效性：在过去的几年里，新的，所谓的“非典型”抗精神病药物已成为治疗精神分裂症。 奥氮平和利培酮是两种最广泛使用的抗精神病药物;它们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的可用性已有十年，但今天美国约40%的抗精神病药物处方仍然是常规药物。 既然非典型抗精神病药物可能比传统药物更有效，副作用也较少，那麽，那些服用较旧药物的情况相对稳定，但仍有症状或受药物副作用困扰的人，是否应该转用非典型药物呢？ 与这种药物转换相关的益处和风险是什么？来自一个大型、多样化的公共精神卫生系统的共计300名同意的精神分裂症患者，他们生活在社区并服用常规抗精神病药物，但仍受到症状或药物副作用的困扰，将被随机分配继续使用当前的常规抗精神病药物（N = 100）或改用奥氮平（N =100）或利培酮（N=100）。 该设计专门控制了更换药物的过程，因为一组继续接受当前治疗。 因此，拟议的研究将评估从常规抗精神病药物转换为一线非典型抗精神病药物的预期增量风险和获益。 所有药物将是开放标签的，治疗将由研究参与者的常规提供者提供。研究参与者将被要求在指定的治疗条件下停留6个月，之后药物决定将由患者和处方精神科医生决定。 将在基线和随访间隔1年时使用定量工具对研究参与者进行访谈，以确定临床病程和使用的服务类型。 该研究将确定从常规药物转换为最常用的非典型抗精神病药物的增量风险和获益，以及转换为奥氮平与转换为利培酮的相对风险和获益。