奥氮平治疗边缘型人格障碍患者
2006年7月21日 更新者：Eli Lilly and Company
奥氮平对边缘性人格障碍患者的疗效和安全性：与安慰剂的随机灵活剂量双盲比较
本研究的目的是确定：奥氮平的安全性和可能与之相关的任何副作用，奥氮平与安慰剂的比较，奥氮平是否可以帮助患有边缘性人格障碍 (BPD) 症状的患者，以及奥氮平应该服用多少给予患者。
研究概览
研究类型
介入性
注册
300
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Aachen、德国
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Berlin、德国
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Freiburg、德国
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Mannheim、德国
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Rostock、德国
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Stralsund、德国
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Brattvag、挪威
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Oslo、挪威
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Brussels、比利时
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Kortenberg、比利时
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Liege、比利时
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Nieuwkerken-Waas、比利时
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Tielt、比利时
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Bordeaux Cedex、法国
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Bully Les Mines、法国
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Colombes Cedex、法国
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Dijon Cedex、法国
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Le Kremlin Bicetre、法国
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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Marseille Cedex 09、法国
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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Nimes Cedex 4、法国
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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Paris、法国
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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Sceaux、法国
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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Toulouse、法国
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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Alvsjo、瑞典
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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Stockholm、瑞典
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Georgia
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Atlanta、Georgia、美国
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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Marietta、Georgia、美国
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Minnesota
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Minneapolis、Minnesota、美国
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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Nevada
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Las Vegas、Nevada、美国
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North Dakota
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Bismarck、North Dakota、美国
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Pennsylvania
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Media、Pennsylvania、美国
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Virginia
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Charlottesville、Virginia、美国
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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Virginia Beach、Virginia、美国
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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Washington
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Bellevue、Washington、美国
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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London、英国
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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Lisbon、葡萄牙
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Porto、葡萄牙
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Barcelona、西班牙
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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Madrid、西班牙
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
15年 至 65年 (孩子、成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
纳入标准：
- 患者必须在第 1 次就诊和第 2 次就诊时处于门诊状态。
- 患者在第一次就诊时必须为 15 至 65 岁。
- 患者必须满足人格障碍的所有 DSM-IV-TR 一般诊断标准，并且患者必须满足 BPD 的 DSM-IV-TR 诊断标准。
- 根据 ZAN-BPD 总分评估的症状严重程度，由接受过 BPD 评估和评估培训的精神科医生确认，在第 2 次就诊时必须大于或等于 9。
- 有生育能力的女性患者必须对妊娠进行阴性测试，并且必须在整个研究过程中使用医学上可接受的避孕方法。
排除标准：
- 患者不得是研究人员、直接与研究相关的研究现场人员或直接与研究相关的研究现场人员的直系亲属。 直系亲属被定义为配偶、父母、子女或兄弟姐妹，无论是亲生的还是合法收养的。
- 礼来公司雇用的人员（即员工、临时合同工或负责开展研究的指定人员）。 Lilly 员工的直系亲属可以参加 Lilly 赞助的临床试验，但不允许参加 Lilly 设施。 直系亲属被定义为配偶、父母、子女或兄弟姐妹，无论是亲生的还是合法收养的。
- 患者之前不得参与（已随机化）或退出本研究或礼来赞助的任何其他调查奥氮平的研究。
- 患者之前不得接受过奥氮平治疗，除非研究者认为患者之前的治疗剂量或持续时间不足以提供对治疗的准确评估，或者奥氮平的效果被合并用药混淆。
- 女性患者不得怀孕或哺乳。
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
研究衡量的是什么？
主要结果指标
结果测量 |
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评估奥氮平疗法（2.5 至 20.0 毫克/天）与安慰剂相比在大于或等于
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等于 18 岁，诊断为 DSM-IV-TR 标准所定义的 BPD，改善整体症状学，以平均最后一次观察来衡量
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ZAN-BPD 中的结转 (LOCF) 变化
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在长达 12 周的双盲治疗中的总分。
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次要结果测量
结果测量 |
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评估奥氮平治疗（2.5 至 20.0 毫克/天）与安慰剂相比对年龄大于或等于 15 岁且小于 18 岁的患者的疗效
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根据 DSM-IV-TR 标准定义的 BPD 改善整体症状学，通过长达 12 周的双盲治疗的 ZAN-BPD 总分的平均 LOCF 变化来衡量。
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Houston J, Dharia S, Bishop JR, Ellingrod VL, Fijal B, Jacobson JG, Hoffmann VP. Association of DRD2 and ANKK1 polymorphisms with prolactin increase in olanzapine-treated women. Psychiatry Res. 2011 May 15;187(1-2):74-9. doi: 10.1016/j.psychres.2010.10.020. Epub 2010 Nov 20.
- Houston JP, Kohler J, Bishop JR, Ellingrod VL, Ostbye KM, Zhao F, Conley RR, Poole Hoffmann V, Fijal BA. Pharmacogenomic associations with weight gain in olanzapine treatment of patients without schizophrenia. J Clin Psychiatry. 2012 Aug;73(8):1077-86. doi: 10.4088/JCP.11m06916.
- Stoffers-Winterling JM, Storebo OJ, Pereira Ribeiro J, Kongerslev MT, Vollm BA, Mattivi JT, Faltinsen E, Todorovac A, Jorgensen MS, Callesen HE, Sales CP, Schaug JP, Simonsen E, Lieb K. Pharmacological interventions for people with borderline personality disorder. Cochrane Database Syst Rev. 2022 Nov 14;11(11):CD012956. doi: 10.1002/14651858.CD012956.pub2.
- Schulz SC, Zanarini MC, Bateman A, Bohus M, Detke HC, Trzaskoma Q, Tanaka Y, Lin D, Deberdt W, Corya S. Olanzapine for the treatment of borderline personality disorder: variable dose 12-week randomised double-blind placebo-controlled study. Br J Psychiatry. 2008 Dec;193(6):485-92. doi: 10.1192/bjp.bp.107.037903.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2004年3月1日
研究完成
2005年11月1日
研究注册日期
首次提交
2004年9月14日
首先提交符合 QC 标准的
2004年9月24日
首次发布 (估计)
2004年9月27日
研究记录更新
最后更新发布 (估计)
2006年7月24日
上次提交的符合 QC 标准的更新
2006年7月21日
最后验证
2006年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
边缘性人格障碍的临床试验
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Hospital Universitari Vall d'Hebron Research InstituteInstituto de Salud Carlos III完全的
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Dren BioNovotech招聘中侵袭性 NK 细胞白血病 | 肝脾T细胞淋巴瘤 | 肠病相关的T细胞淋巴瘤 | 皮下脂膜炎样 T 细胞淋巴瘤 | 单形性趋上皮性肠 T 细胞淋巴瘤 | LGLL - 大颗粒淋巴细胞白血病 | 原发性皮肤 T 细胞淋巴瘤 - 类别 | 原发性皮肤 CD8 阳性侵袭性嗜表皮 T 细胞淋巴瘤 | 系统性 EBV1 T 细胞淋巴瘤，如果 CD8 阳性 | Hydroa Vacciniforme-Like Lymphoproliferative Disorder | 结外 NK/T 细胞淋巴瘤，鼻型 | 胃肠道惰性慢性淋巴增生性疾病 (CLPD)（CD8+ 或 NK 衍生） | 上面未列出的其他 CD8+/NK 细胞驱动的淋巴瘤美国, 澳大利亚, 法国, 西班牙
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Memorial Sloan Kettering Cancer Center招聘中蕈样肉芽肿 | 塞扎里综合症 | 血管免疫母细胞性T细胞淋巴瘤 | 肝脾T细胞淋巴瘤 | 间变性大细胞淋巴瘤，ALK 阳性 | 结外 NK/T 细胞淋巴瘤，鼻型 | T细胞淋巴瘤 | 未特指的外周 T 细胞淋巴瘤 | 原发性皮肤间变性大细胞淋巴瘤 | 皮下脂膜炎样 T 细胞淋巴瘤 | 肠病相关的T细胞淋巴瘤 | 间变性大细胞淋巴瘤，ALK 阴性 | 单形性趋上皮性肠 T 细胞淋巴瘤 | T 细胞幼淋巴细胞白血病 | T 细胞大颗粒淋巴细胞白血病 | 原发性皮肤 CD8 阳性侵袭性嗜表皮 T 细胞淋巴瘤 | Hydroa Vacciniforme-Like Lymphoproliferative Disorder | NK细胞淋巴瘤 | 侵袭性 NK 细胞白血病 | 成人 T 细胞白血病/淋巴瘤 及其他条件美国