Changing from Conventional to Risperidone Decanoate

从传统药物改为利培酮癸酸酯

• 批准号: 6953185
• 负责人: NANCY H COVELL
• 金额: $ 7.4万
• 依托单位: UNIVERSITY OF CONNECTICUT STORRS
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-09-29 至 2008-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6953185
• 关键词: alcoholic beverage consumption; behavioral /social science research tag; clinical research; drug adverse effect; fluphenazine; functional ability; haloperidol; health care service utilization; human subject; human therapy evaluation; injection /infusion; interview; mental disorder chemotherapy; neuropsychological tests; neuropsychology; patient oriented research; risperidone; satisfaction; schizoid personality; schizophrenia; sign /symptom; substance abuse related disorder; therapy compliance

DESCRIPTION (provided by applicant): As many as 1 in 5 individuals with schizophrenia taking antipsychotic medications are maintained on a first-generation depot. These individuals may not be candidates for treatment with oral second-generation antipsychotic medications for a variety of reasons, including concerns about medication adherence and patient preference. We know surprisingly little about the expected risks and gains associated with changing from first- to second-generation antipsychotic medications. One currently funded NIMH study (R01MH59312; Susan M. Essock, Ph.D., PI) was designed to examine the effectiveness of staying on a first generation antipsychotic medication versus switching to risperidone, olanzapine, or ziprasidone. Given that the FDA is about to approve a long-acting injectable form of risperidone, we have designed a study to answer this question for those individuals taking first-generation depots. This study would address the following question, "Should people who are relatively stable on one of the first-generation depot antipsychotic medications (fluphenazine or haloperidol) but who are still symptomatic or troubled by medication side effects be switched to long-acting injectable risperidone?" To answer this question, we will examine 236 consenting patients from a large, diverse public mental health system, who are living in the community and taking first-generation depot antipsychotic medications but who are still troubled by symptoms or medication side effects. Subjects will be randomly assigned to stay on their current first-generation depot (N=118) or to change to long-acting injectable risperidone (N=118). All medications will be open label, and treatment will be by the subjects' routine providers. Subjects 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. Subjects will be interviewed with quantitative instruments at baseline and at follow-up intervals for 1 year.

描述(由申请人提供)：在第一代仓库中，服用抗精神病药物的精神分裂症患者多达五分之一。这些人可能因为各种原因而不适合口服第二代抗精神病药物治疗，包括对服药依从性和患者偏好的担忧。令人惊讶的是，我们对从第一代抗精神病药物改为第二代抗精神病药物的预期风险和收益知之甚少。目前资助的一项NIMH研究(R01MH59312；Susan M.Essock，Ph.D.，PI)旨在检查继续服用第一代抗精神病药物与改用利培酮、奥氮平或齐拉西酮的有效性。鉴于FDA即将批准一种长效可注射形式的利培酮，我们设计了一项研究，为那些服用第一代仓库的人回答这个问题。这项研究将解决以下问题：“那些对第一代抗精神病药物(氟奋乃静或氟哌啶醇)相对稳定，但仍有症状或受到药物副作用困扰的人，是否应该改用长效注射利培酮？”为了回答这个问题，我们将检查236名来自大型、多样化的公共精神卫生系统的同意患者，他们生活在社区，正在服用第一代仓库抗精神病药物，但仍受到症状或药物副作用的困扰。受试者将被随机分配到他们目前的第一代仓库(N=118)或改用长效注射利培酮(N=118)。所有药物都将是开放标签的，治疗将由受试者的常规提供者进行。受试者将被要求在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。受试者将在基线和随访间隔1年内用量化工具进行访谈。