OUTPATIENT TREATMENT--TARGETED VS MAINTENANCE MEDICATION

门诊治疗——靶向药物与维持药物

• 批准号: 2244457
• 负责人: William T. Carpenter
• 金额: $ 36.08万
• 依托单位: UNIVERSITY OF MARYLAND BALTIMORE
• 依托单位国家: 美国
• 财政年份: 1987
• 资助国家: 美国
• 起止时间: 1987-09-01 至 1997-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2244457
• 关键词: diazepam; dosage; drug administration routes; drug adverse effect; drug withdrawal; fluphenazine; human subject; human therapy evaluation; mental disorder chemotherapy; mental health facility; outpatient care; prolactin; relapse /recurrence; schizophrenia; tranquilizer

During the first five years of this project, we compared the efficacy of a targeted, early intervention strategy using neuroleptic medication with a strategy using early intervention (increased dosage) that supplemented ongoing maintenance neuroleptic therapy. Our experience to date is useful for the work proposed in the current application in several ways. First, we have developed a rapid, effective pharmacologic intervention at relapse for patients assigned to either drug-free or experimental drug status. Since targeted, early intervention treatment efforts are feasible and effective, the consequences of ineffective experimental or placebo treatment need not be severe deterioration in clinical state. Second, our experience with the early intervention, targeted neuroleptic strategy suggests the likelihood that highly sensitive detection of a prodromal syndrome includes symptoms that are false-positive with respect to relapse and often includes psychopathology likely to be susceptible to anxiolytic drug treatment. Third, we now have a trained and experienced clinical staff with established competence in dealing with chronically and severely mentally ill patients within the protocol demands of controlled clinical studies. Fourth, we have gained the logistical experience necessary for conducting outpatient clinical trials. As originally described, the specific aims of the project were to determine the relative effectiveness of two pharmacotherapeutic approaches to the care of schizophrenic outpatients, one involving the targeted use of neuroleptic drugs for symptom exacerbation and the other involving the use of these same drugs for maintenance purposes. At the outset, the feasibility and ethics of the noncontinuous targeted approach were heatedly debated; however, the potential advantages of this alternative strategy for the actively noncompliant patient were compelling, and there was a growing appreciation that placebo controlled continuous drug trials had not addressed the central hypothesis of this project. The possibility that this approach would be a feasible alternative for a substantial proportion of schizophrenic patients was sufficiently attractive to merit empirical evaluation in a random assignment, comparative treatment study. The immediate goal was to ascertain if a substantial reduction in the use of neuroleptic drugs could be achieved without adversely affecting course and outcome status as reflected in symptomatic clinical decompensation and the need for hospital care.

在这个项目的前五年，我们比较了 有针对性的早期干预策略的有效性， 抗精神病药物与早期干预策略 （增加剂量）补充持续维持 神经抑制剂治疗 我们迄今为止的经验对 本申请中提出的工作以几种方式进行。 第一、 我们开发了一种快速有效的药物干预 对于分配至无药物或 实验药物状态。 有针对性的早期干预 治疗措施是可行和有效的， 无效的实验或安慰剂治疗不一定严重 临床状态恶化。 第二，我们的经验 早期干预、有针对性的神经安定药策略表明， 对前驱综合征的高灵敏度检测 包括复发方面的假阳性症状 通常包括精神病理学， 抗焦虑药物治疗 第三，我们现在有一个训练有素的， 经验丰富的临床工作人员，在处理 患有慢性和严重精神疾病的患者， 对照临床研究的方案要求。 四是 获得了必要的后勤经验， 门诊临床试验。 如最初所述，该项目的具体目标是 确定两种药物的相对有效性 精神分裂症门诊病人的护理方法，其中包括 针对症状加重的抗精神病药物的靶向使用 另一种是使用同样的药物 维护目的。 从一开始， 非连续性定向治疗方法引起了激烈的争论; 然而，这种替代战略的潜在优势， 主动不依从患者是令人信服的， 越来越多的人认识到安慰剂控制了连续用药， 试验没有解决这个项目的中心假设。 这一办法成为可行替代办法的可能性 很大一部分精神分裂症患者 有足够的吸引力，值得在一个随机的经验评估 分配，比较治疗研究。 目前的目标是确定是否大幅度减少 使用精神抑制药物可以实现， 影响病程和结局状态， 临床失代偿和需要住院治疗。