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: 3376160
• 负责人: MARVIN I HERZ
• 金额: $ 1.03万
• 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 1991-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3376160
• 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，试图 间歇性抗精神病药物的相对疗效评价 给药(仅在出现复发的前兆迹象时给药) 以及为稳定的精神分裂症门诊患者提供维持药物。 这项研究已经资助了五年，但由于 招收病人，还需要一年半的时间才能完成 项目。140名患者进入药物淘汰赛 研究阶段，101名患者被随机分为 间歇性或维护组。到第六年年底，所有 患者将完成研究方案，六个月后 被分配用于数据分析。 研究已经证明，间歇性的 该方法是安全的，几乎没有明显增加的风险 那些服用安慰剂的人再次住院。到目前为止，有17名患者 住院治疗，7人服用积极药物，10人服用安慰剂。它 也已经确定，接受积极药物治疗的患者 服用的药物明显多于服用安慰剂的人 学习的过程。那些服用安慰剂的人停止了积极的药物治疗 大多数时候都是这样。既然已经确定了可行性， 重要的问题是有效性和确定哪一种 患者宜采用间歇性入路。我们会 继续分析有关前兆发作的数据，以便 确定症状的严重程度和持续时间 比较服用维持性药物和服用维持性药物的次数 安慰剂。其他重要的问题是比较群体之间的关系 症状的严重性和角色的损害 功能、家庭负担、延误发生率和严重程度 运动障碍。