EFFECTIVENESS OF SWITCHING: CONVENTIONALS TO ATYPICALS

转换的有效性：从常规到非典型

• 批准号: 6287978
• 负责人: Susan M Essock
• 金额: $ 96.64万
• 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/6287978
• 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：传统药物到非典型药物 在过去的几年里，新的所谓“非典型”抗精神病药物已可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；它们合计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日常实践中的有效性知之甚少。 尽管非典型抗精神病药已有十年历史，但目前美国约 40% 的抗精神病药处方仍然是传统药物。 鉴于非典型抗精神病药物可能比传统药物更有效且副作用更小，那些对旧药物治疗相对稳定但仍然有症状或受到药物副作用困扰的人是否应该改用非典型药物？ 这种药物转换有哪些好处和风险？来自大型、多元化的公共精神卫生系统的总共 300 名同意的精神分裂症患者将被随机分配到继续接受目前的治疗，这些患者居住在社区并服用常规抗精神病药物，但仍然受到症状或药物副作用的困扰。常规抗精神病药物 (N = 100) 或改用奥氮平 (N = 100) 或利培酮 (N = 100)。 该设计特别控制了改变药物的过程，因为一组继续当前的治疗。 因此，拟议的研究将评估从传统药物转为一线非典型抗精神病药物可带来哪些增量风险和益处。 所有药物都将是开放标签，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保持 6 个月，之后药物治疗的决定将由患者和开处方的精神科医生做出。 研究参与者将在基线和一年的随访间隔内接受定量仪器采访，以确定临床过程和所使用的服务类型。 该研究将确定从传统药物转换为最常用的非典型抗精神病药物的增量风险和益处，以及改用奥氮平与利培酮相比的相对风险和益处。