TARDIVE DYSKINESIA INCIDENCE AND ATYPICAL ANTIPSYCHOTIC

迟发性运动障碍的发生率和非典型抗精神病药物

• 批准号: 6765116
• 负责人: Scott W Woods
• 金额: $ 24.86万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2000
• 资助国家: 美国
• 起止时间: 2000-08-15 至 2006-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6765116
• 关键词: antipsychotic agents; clinical research; combination chemotherapy; drug adverse effect; human subject; human therapy evaluation; longitudinal human study; mental disorder chemotherapy; psychosis; risperidone; serotonin inhibitor; tardive dyskinesia

DESCRIPTION (Adapted from the Applicant's Abstract): Among the drivers of the rapidly expanding use of the newer atypical antipsychotic medications (olanzapine, risperidone, quetiapine) is the claim that the atypical antipsychotic medications are associated with a lower risk for the development of tardive dyskinesia than are the older conventional drugs. Whether this claim is true is of great clinical, medicolegal, and pharmacoeconomic importance. Preclinical studies provide a credible rationale for why the newer atypical medications may have a lower risk of tardive dyskinesia than the conventionals; however, their lower risk has been addressed so far directly by only one published controlled efficacy trial and one study in the elderly. The purpose of the present application is to provide complementary data to these studies by using a naturalistic incidence study method. The current project proposes to investigate whether the incidence of persistent TD among patients taking atypical antipsychotic medications, alone or in combination with conventional medications, is lower than the incidence among patients taking conventional antipsychotics alone. In addition we will investigate other risk factors including affective disorder diagnosis associated with the incidence of TD in patients taking atypical antipsychotic medications and explore the prognosis and course of incident cases. To address these aims, a new sample of approximately 838 patients free of persistent TD will be recruited from the outpatient population of the Connecticut Mental Health Center (CMHC). These patients will be followed with biannual examinations for an average of 3.25 years. The CMHC was the site of a previous NIMH sponsored study (MH39665) that determined the incidence of new TD cases in the CMHC outpatient population from a sample identified between July 1, 1985 and December 31, 1986 and followed for up to 5 years. The existence of a previous sample at the same site provides a useful additional comparison group. Methods including sample ascertainment and TD assessment are closely modeled after the original work.

描述（改编自申请人的摘要）：在本发明的驱动因素中， 新型非典型抗精神病药物的使用迅速扩大 （奥氮平，利培酮，奎替卡松）是声称非典型的 抗精神病药物与较低的发展风险相关 迟发性运动障碍的治疗效果这一主张是否 具有重要的临床、法医学和药物经济学意义。 临床前研究提供了一个可信的理由，为什么新的非典型 药物可能比常规药物具有较低的迟发性运动障碍风险; 然而，到目前为止，只有一个国家直接提到了它们较低的风险， 已发表的对照疗效试验和一项老年人研究。目的 本申请的目的是通过以下方式为这些研究提供补充数据： 使用自然主义的关联研究方法。 目前的项目建议调查是否持续的发病率 单独或联合使用非典型抗精神病药物的患者中的TD 与常规药物联合使用，其发生率低于 单独服用常规抗精神病药物的患者。此外，我们将 调查其他风险因素，包括情感障碍诊断 与服用非典型抗精神病药患者TD的发生率相关 药物治疗，并探讨事件的预后和过程。 为了实现这些目标，一个新的样本约838例患者免费 持续性TD将从 康涅狄格州心理健康中心（CMHC）。这些患者将接受以下随访： 每两年检查一次，平均3.25年。 CMHC是先前NIMH申办的研究（MH39665）的研究中心， 确定CMHC门诊人群中新发TD病例的发生率， 在1985年7月1日至1986年12月31日期间确定的样本， 最多5年。在同一地点的先前样本的存在提供了 有用的额外比较组。方法包括样品测定和 TD评估是在原始工作之后紧密建模的。