EFFICACY OF ZIPRASIDONE VS PLACEBO IN BORDERLINE PERSONALITY DISORDER

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 《精神疾病诊断和统计手册》(第四版)(DSM IV-TR2000)将BPD归类为轴二型B类人格障碍。DSM IV诊断BPD的标准包括情绪不稳定、冲动冒险行为、不适当和强烈的愤怒、在理想化和贬低之间迅速转变的不稳定的关系、不稳定的自我形象、空虚感、分离经历、自我伤害行为，如皮肤浅表割伤或灼伤，以及多次自杀未遂(DSM IV-TR2000)。 BPD被指定为Axis II人格障碍反映了历史上的概念化，即人格障碍是心理和发展方面的根源，而不是像Axis I障碍那样基于生物和遗传决定的。 最近，对BPD和人格障碍的另一种概念化出现，为使用药物治疗BPD提供了理论基础。本研究旨在评估齐拉西酮治疗边缘性人格障碍的疗效和耐受性。 这项研究的总体目标是通过对40名成年参与者进行为期10周的安慰剂对照试验，确定齐拉西酮治疗BPD的疗效。齐拉西酮目前被美国食品和药物管理局批准用于治疗躁狂和混合发作。 假设： 基本假设： 1.根据ZAN-BPD的衡量，齐拉西酮在治疗全球严重程度方面将优于安慰剂。 第二个假设： 1.在治疗CGI-I衡量的全球严重程度方面，齐拉西酮将优于安慰剂。 2.根据《青年躁狂症评定量表》的衡量，齐拉西酮在改善躁狂谱症状方面优于安慰剂。 3.根据修改后的显性攻击量表，齐拉西酮在治疗易怒和攻击性方面优于安慰剂。 4.用情感不稳定量表(ALS)衡量，齐拉西酮在治疗情感不稳定方面优于安慰剂。 5.齐拉西酮在改善希罕残疾量表所衡量的功能残疾方面优于安慰剂。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The Diagnostic and Statistical Manual of Mental Disorders (4th Edition) (DSM IV-TR 2000) classifies BPD as an Axis II Cluster B Personality Disorder. DSM IV criteria for BPD include affective instability, impulsive risk taking behavior, inappropriate and intense anger, unstable relationships that rapidly shift between idealization and devaluation, unstable self image, feelings of emptiness, dissociative experiences, self injurious behavior such as superficial skin cutting or burning, and multiple suicide attempts (DSM IV-TR 2000). The designation of BPD as an Axis II personality disorder reflects the historical conceptualization that personality disorders are psychologically and developmentally rooted, rather than biologically based and genetically determined such as the Axis I disorders. More recently, alternative conceptualizations of BPD and personality disorders have arisen, lending theoretical rationale for the use of medications in the treatment of BPD. The current study aims to assess the efficacy and tolerability of ziprasidone in the treatment of borderline personality disorder. The overall aim of this study is to determine the efficacy of ziprasidone in the treatment of BPD via a 10-week placebo-controlled trial in 40 adult participants. Ziprasidone is currently approved for the treatment of manic and mixed episodes by the U.S. Food and Drug Administration. HYPOTHESIS: PRIMARY HYPOTHESIS: 1. Ziprasidone will be superior to placebo in treating global severity, as measured by the ZAN-BPD. SECONDARY HYPOTHESIS: 1. Ziprasidone will be superior to placebo in treating global severity as measured by the CGI-I. 2. Ziprasidone will be superior to placebo in improving manic-spectrum symptoms, as measured by the Young Mania Rating Scale. 3. Ziprasidone will be superior to placebo in treating irritability and aggression, as measured by the Overt Aggression Scale - Modified. 4. Ziprasidone will be superior to placebo in treating affective instability as measured by the Affective Lability Scale (ALS). 5. Ziprasidone will be superior to placebo in improving functional disability, as measured by the Sheehan Disability Scale.