CONTINUATION PHARMACOTHERAPY FOR AGITATION OF DEMENTIA

描述(改编自申请人的摘要)：本报告的主要目标 修订申请(MH59666)“持续药物治疗激动症” 痴呆症“是进行为期12周的双盲对照研究 高选择性的5-羟色胺再摄取抑制剂的有效性， 西酞普兰与非典型抗精神病药物地培酮治疗103例 患有与阿尔茨海默病相关的行为障碍 (BDAD)。这项研究的重点是阿尔茨海默病患者及其刘易斯 受影响最严重的身体变种：那些需要首字母 BDAD住院治疗。医院对BDAD的对症处理 在过去的五年里有了很大的改善。不幸的是，缩短的长度 保留现在是强制的，BDAD很可能复发和重复 住院治疗与更快的功能衰退有关。我们的飞行员 数据表明，抗抑郁剂西酞普兰对两者都有很大的好处。 住院患者的精神病性和非精神病性BDAD症状，至少在 短期而言。减轻焦虑感和精神病症状 西酞普兰似乎与我们的药物相当或更好 既往治疗标准为常规抗精神病药物，奋乃静。这个 奋乃静治疗患者的副作用负担增加 然而，与西酞普兰组和安慰剂组相比，这一点意义重大。 尽管如此，这项疗效研究是在高度受控的、 专门的住院环境，时间非常短(17天)。 此外，在社区实践中，非典型的抗精神病药物Rispedo已经 成为BDAD的一线用药。要解决持续治疗问题， 在社区或养老院(即，在我们的学术环境之外)，我们 建立了对BDAD患者的治疗和评估系统 他们出院了。药物分配和剂量调整 将保持失明状态，患者将受到仔细监测。除了……之外 临床和行为结果评估，拟议的研究还将 检查治疗反应是否与个体间有关 5-羟色胺转运体启动子--5-羟色胺2N2C的等位基因变异 受体和CYP2D6药物代谢同工酶。血药浓度监测 将被用来评估由于以下原因造成的药物暴露差异的影响 在遵从性或毒品清除量方面的偏差。

DESCRIPTION (Adapted from the Applicant's Abstract): The primary goal of this revised application (MH59666) "Continuation Pharmacotherapy for Agitation of Dementia" is to conduct a 12-week, double-blind study of the comparative effectiveness of the highly selective, serotonin reuptake inhibitor, citalopram, and the atypical antipsychotic, dsperidone in 103 patients suffering from behavioral disturbances associated with Alzheimer's dementia (BDAD). This study focuses on patients with Alzheimer's disease and its Lewy body variant who are most severely affected: those who have required initial hospitalization for BDAD. Symptomatic management of BDAD in the hospital has greatly improved over the past five years. Unfortunately, shortened lengths of stay are now mandated and BDAD has a high likelihood to recur and repeated hospitalizations are associated with more rapid functional decline. Our pilot data suggest that the antidepressant citalopram is acutely beneficial for both psychotic and non-psychotic BDAD symptoms in hospitalized patients, at least in the short-term. Attenuation of agitation and psychotic symptoms achieved with citalopram appeared to be equivalent to, or better than that achieved with our prior treatment standard, the conventional neuroleptic, perphenazine. The increase in side effect burden for the perphenazine-treated patients was significant, however, in contrast to the citalopram and placebo groups. Nonetheless, this efficacy study was conducted in a highly controlled, specialized, inpatient environment, for a very brief period of time (17 days). Moreover, in community-practice, the atypical antipsychotic, rispeddone has become a first-line medication for BDAD. To address continuing treatment in the community or in the nursing home (i.e., outside of our academic setting) we have established a system of treatment and assessment for BDAD patients upon their discharge from the hospital. Medication assignment and dosage adjustments will remain blinded and patients will be carefully monitored. In addition to clinical and behavioral assessments of outcomes, the proposed study will also examine whether therapeutic response is associated with inter-individual allelic variations in the serotonin transporter promoter, serotonin 2N2C receptors, and CYP2D6 drug metabolizing isoenzyme. Drug plasma level monitoring will be utilized to assess the impact of variance in drug exposure due to deviations in compliance or drug clearance.