EFFICACY OF ZIPRASIDONE VS PLACEBO IN BORDERLINE PERSONALITY DISORDER

齐拉西酮与安慰剂治疗边缘性人格障碍的疗效

• 批准号: 7953698
• 负责人: DAPHNE SIMEON
• 金额: $ 0.17万
• 依托单位: ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-03-01 至 2009-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7953698
• 关键词: Adult; Affective; Aggressive behavior; Anger; Behavior; Borderline Personality Disorder; Bronchopulmonary Dysplasia; Burn injury; Clinical Research; Computer Retrieval of Information on Scientific Projects Database; DSM-IV; Diagnostic and Statistical Manual; Disease; Feeling; Funding; Grant; Institution; Manic; Measures; Participant; Personality Disorders; Pharmaceutical Preparations; Placebos; Plant Roots; Research; Research Personnel; Resources; Risk-Taking; Self Perception; Self-Injurious Behavior; Severities; Skin; Source; Suicide attempt; Symptoms; United States Food and Drug Administration; United States National Institutes of Health; base; disability; experience; functional disability; improved; placebo controlled study; ziprasidone

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.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目和 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 《精神疾病诊断与统计手册》（第 4 版）（DSM IV-TR 2000）将 BPD 归类为 Axis II B 族人格障碍。 DSM IV 的 BPD 标准包括情感不稳定、冲动的冒险行为、不恰当和强烈的愤怒、在理想化和贬低之间快速转变的不稳定关系、不稳定的自我形象、空虚感、分离体验、自伤行为（如割伤或烧伤浅层皮肤）以及多次自杀企图（DSM IV-TR 2000）。 将 BPD 指定为轴 II 型人格障碍反映了历史概念，即人格障碍具有心理和发育根源，而不是像轴 I 型人格障碍那样基于生物学和基因决定。 最近，出现了 BPD 和人格障碍的替代概念，为使用药物治疗 BPD 提供了理论依据。目前的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。 本研究的总体目的是通过对 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。 齐拉西酮目前已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： 主要假设： 1. 根据 ZAN-BPD 的测量，齐拉西酮在治疗总体严重程度方面优于安慰剂。 第二个假设： 1. 根据 CGI-I 的衡量，齐拉西酮在治疗总体严重程度方面优于安慰剂。 2. 根据青年躁狂评定量表的测量，齐拉西酮在改善躁狂谱系症状方面优于安慰剂。 3. 齐拉西酮在治疗烦躁和攻击行为方面优于安慰剂，根据公开攻击行为量表 - 改良版进行测量。 4. 根据情感不稳定性量表（ALS）测量，齐拉西酮在治疗情感不稳定方面优于安慰剂。 5. 根据希恩残疾量表的测量，齐拉西酮在改善功能残疾方面优于安慰剂。