Changing from Conventional to Risperidone Decanoate

描述（由申请人提供）：多达1/5的服用抗精神病药物的精神分裂症患者维持在第一代药物库中。 由于各种原因，这些人可能不是口服第二代抗精神病药物治疗的候选人，包括对药物依从性和患者偏好的担忧。 令人惊讶的是，我们对从第一代到第二代抗精神病药物的预期风险和收益知之甚少。 一项目前资助的NIMH研究（R 01 MH 59312; Susan M. Essock博士，PI）旨在检查继续使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即将批准利培酮的长效注射剂形式，我们设计了一项研究来回答这些服用第一代长效制剂的人的这个问题。 这项研究将解决以下问题，“对于第一代长效抗精神病药物（氟奋乃静或氟哌啶醇）之一相对稳定，但仍有症状或受药物副作用困扰的人，是否应该改用长效注射用利培酮？“为了回答这个问题，我们将检查来自一个大型，多样化的公共精神卫生系统的236名同意患者，他们生活在社区并服用第一代长效抗精神病药物，但仍然受到症状或药物副作用的困扰。 受试者将被随机分配继续使用当前的第一代贮库型药物（N=118）或改为长效注射用利培酮（N=118）。 所有药物将是开放标签的，治疗将由受试者的常规提供者提供。 将要求受试者在指定的治疗条件下保持6个月，之后将由患者和处方精神科医生决定药物治疗。 将在基线和随访间隔1年时使用定量工具对受试者进行访谈。

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.