EFFECTIVENESS OF SWITCHING: CONVENTIONALS TO ATYPICALS

转换的有效性：从常规到非典型

• 批准号: 6538889
• 负责人: Susan M Essock
• 金额: $ 133.87万
• 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/6538889
• 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：常规药物转向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以用于治疗精神分裂症。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，我们对这些新药在常规实践环境中的有效性知之甚少，这令人惊讶。尽管非典型抗精神病药物已经有十年的时间了，但今天美国约有40%的抗精神病药物处方仍然是常规药物。鉴于非典型抗精神病药物可能比传统药物更有效，副作用更少，那么那些对旧药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？与这种药物转换相关的好处和风险是什么？来自一个庞大、多样化的公共精神卫生系统的300名同意接受精神分裂症治疗的患者将被随机分配到继续使用目前的传统抗精神病药物(N=100)或改用奥氮平(N=100)或利培酮(N=100)。这些患者生活在社区，正在服用传统的抗精神病药物，但仍受到症状或药物副作用的困扰。该设计专门控制换药过程，因为有一组继续目前的治疗。因此，这项拟议的研究将评估从传统抗精神病药物转换为一线非典型抗精神病药物预计会带来什么增量风险和好处。所有药物都将是开放标签的，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他们指定的治疗条件下停留6个月，在此之后，药物治疗将由患者和开处方的精神病医生决定。研究参与者将在基线和随访间隔1年内使用量化工具进行访谈，以确定临床病程和所使用的服务类型。这项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好处，以及转换为奥氮平和转换为利培酮的相对风险和好处。