INTERMITTENT VS MAINTENANCE MEDICATION IN SCHIZOPHRENIA

精神分裂症的间歇性药物治疗与维持性药物治疗

• 批准号: 3376155
• 负责人: MARVIN I HERZ
• 金额: $ 22.93万
• 依托单位: STATE UNIVERSITY OF NEW YORK AT BUFFALO
• 依托单位国家: 美国
• 财政年份: 1983
• 资助国家: 美国
• 起止时间: 1983-04-15 至 1990-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3376155
• 关键词: chronic disease /disorder; drug adverse effect; human subject; human therapy evaluation; mental disorder chemotherapy; patient care; schizophrenia; social adjustment; tardive dyskinesia; tranquilizer

This is a double blind placebo controlled study which attempts to evaluate the relative efficacy of intermittent antipsychotic drug administration (given only when prodromal signs of relapse appear) and maintenance medication for stable schizophrenic outpatients. The study had been funded for five years but due to delays in enrolling patients, it will take 1 1/2 more years to complete the project. One hundred and forty patients entered the drug washout phase of the study, and 101 patients were randomized into the intermittent or maintenance groups. By the end of Year 6, all patients will have completed the study protocol, and six months are allocated for analysis of data. The study has already demonstrated that the intermittent approach is safe with little apparent increased risk of rehospitalization for those on placebo. To date 17 patients have been hospitalized, 7 on active medication and 10 on placebo. It also has been determined that patients on active medication are on significantly more medication than those on placebo during the course of the study. Those on placebo are off active medication most of the time. Since feasibility has been established, the important issues are efficacy and the ability to determine which patients are appropriate for the intermittent approach. We will continue to analyze data regarding prodromal episodes in order to determine the severity of symptoms and the duration of the episodes comparing those on maintenance medication and those on placebo. Other important issues are to compare groups regarding the severity of symptomatology and impairment of role functioning, family burden, and incidence and severity of tardive dyskinesia.

这是一项双盲安慰剂对照研究， 评价间歇性抗精神病药物的相对疗效 给药（仅在出现复发的前驱体征时给予） 以及稳定的精神分裂症门诊患者的维持药物治疗。 这项研究已经资助了五年，但由于拖延， 招募患者，还需要1年半的时间才能完成 项目 140名患者进入药物洗脱期 101名患者随机分为两组， 间歇性或维护组。 到6月底，所有 患者将完成研究方案， 用于数据分析。 研究表明，间歇性 这种方法是安全的， 安慰剂组再住院治疗。 迄今为止，已有17名患者 住院治疗，7例接受活性药物治疗，10例接受安慰剂治疗。 它 还已经确定，正在服用活性药物的患者 服用的药物明显多于安慰剂组， 学习过程。 那些服用安慰剂的人停止服用活性药物 大部分时间 由于可行性已经确定， 重要的问题是有效性和确定 患者适合间歇性方法。 我们将 继续分析有关前驱发作的数据， 确定症状的严重程度和持续时间 比较维持药物治疗组和 安慰剂 其他重要的问题是比较各组关于 病理学的严重程度和作用的损害 功能、家庭负担、迟发性痴呆的发生率和严重程度 运动障碍