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精神分裂症的长期研究

2026年9月10日 更新者：Denovo Biopharma LLC

Pomaglumetad Methionil 在精神分裂症患者中的长期开放标签安全性研究

本研究的目的是评估 pomaglumetad methionil 在精神分裂症患者中的长期安全性。

研究概览

地位

终止

条件

干预/治疗

详细说明

The primary objective of this study was to evaluate the long-term safety of pomaglumetad methionil (LY2140023) in patients with schizophrenia by monitoring extrapyramidal symptoms (EPS), as evaluated by the Barnes Akathisia Scale (BAS), the Simpson-Angus Scale (SAS), and the Abnormal Involuntary Movement Scale (AIMS); weight; prolactin; and the following metabolic parameters: fasting glucose, total cholesterol, low-density lipoprotein cholesterol (LDL), high-density lipoprotein (HDL) cholesterol, and total triglycerides.

研究类型

介入性

注册 (实际的)

129

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

  • 奥地利
      • Vienna、奥地利、1010
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • 巴西
      • Salvador、巴西、40301500
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • São Paulo、巴西、22270-060
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • 希腊
      • Chaïdári、希腊、12462
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • 德国
      • Dresden、德国、01307
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Oranienburg、德国、16515
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • 法国
      • Limoges、法国、87025
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • 波兰
      • Bialystok、波兰、15-879
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Gdynia、波兰、81-361
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • 波多黎各
      • San Juan、波多黎各、00926
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • 瑞典
      • Luleå、瑞典、SE 972 35
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Malmö、瑞典、21153
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • 罗马尼亚
      • Bucharest、罗马尼亚、041914
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • 美国
    • California
      • Cerritos、California、美国、90703
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Escondido、California、美国、92025
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Garden Grove、California、美国、92845
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Long Beach、California、美国、90813
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • San Diego、California、美国、92123
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Sherman Oaks、California、美国、91403
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Torrance、California、美国、90502
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • District of Columbia
      • Washington D.C.、District of Columbia、美国、20016
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Florida
      • Coral Gables、Florida、美国、33145
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Lauderhill、Florida、美国、33319
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Maitland、Florida、美国、32751
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • North Miami、Florida、美国、33161
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Oakland Park、Florida、美国、33334
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Sanford、Florida、美国、32771
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Illinois
      • Chicago、Illinois、美国、60640
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Indiana
      • Indianapolis、Indiana、美国、46260
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Louisiana
      • Lake Charles、Louisiana、美国、70629
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Mississippi
      • Flowood、Mississippi、美国、39232
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Missouri
      • Creve Coeur、Missouri、美国、63141
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • New Jersey
      • Marlton、New Jersey、美国、08053
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Princeton、New Jersey、美国、08540
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • New York
      • Brooklyn、New York、美国、11235
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Cedarhurst、New York、美国、11516
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Fresh Meadows、New York、美国、11366
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Rochester、New York、美国、14615
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Staten Island、New York、美国、10312
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • North Carolina
      • Charlotte、North Carolina、美国、28211
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Ohio
      • Beachwood、Ohio、美国、44122
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Oklahoma
      • Oklahoma City、Oklahoma、美国、73103
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Oregon
      • Eugene、Oregon、美国、97401
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Pennsylvania
      • Allentown、Pennsylvania、美国、18104
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Philadelphia、Pennsylvania、美国、19139
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Texas
      • Austin、Texas、美国、78754
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • DeSoto、Texas、美国、75115
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Wharton、Texas、美国、77488
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Virginia
      • Richmond、Virginia、美国、23230
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • 西班牙
      • Madrid、西班牙、28031
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Vic、西班牙、08500
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

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

18年 至 65年 (成人、年长者)

接受健康志愿者

不

描述

纳入标准：

  • 参与者被临床诊断为精神分裂症
  • 有生育能力的女性参与者必须在研究开始时进行妊娠测试阴性，并同意使用单一、有效、医学上可接受的节育方法
  • 新参与者必须根据他们目前的临床精神状态和/或作为门诊患者的治疗耐受性表明，需要启动或修改当前的抗精神病药物治疗。 标准不适用于从饲养研究中翻滚的参与者（NCT01328093 和 NCT01452919）
  • 参与者必须被认为是可靠的并且有足够的理解水平来执行协议要求的所有测试和检查，并且愿意执行所有研究程序
  • 参与者必须能够理解研究的性质并已给予自己的知情同意

排除标准：

  • 目前正在参加涉及研究产品 (IP) 或未经批准使用药物或设备的临床试验，或在过去 60 天内中止，或同时参加任何其他类型的医学研究，这些研究被认为不具有科学或医学意义与本研究相容，除了从饲养研究（NCT01328093 和 NCT01452919）中转出的参与者，他们将完成 pomaglumetad methionil 的临床试验
  • 除精神分裂症外，目前还有其他精神病学诊断
  • 之前已经完成或退出这项研究，或任何其他调查 pomaglumetad methionil 或任何具有谷氨酸能活性的前身分子的研究，除了从饲养研究（NCT01328093 和 NCT01452919）中滚动的参与者，他们将完成 pomaglumetad methionil 的临床试验
  • 根据研究者的意见，参与者在进入研究前 12 个月内接受了充分的治疗试验，每天服用剂量大于 200 毫克的氯氮平，或者在进入研究前的一个月内接受过任何氯氮平治疗
  • 对精神分裂症的抗精神病药物治疗有不充分临床反应史的参与者
  • 出于任何原因被认为对自己有危险或积极表现出自杀行为的参与者
  • 怀孕、哺乳或打算在完成研究后 30 天内怀孕的女性参与者
  • 患有已知的、未矫正的窄角型青光眼
  • 患有癫痫症、白细胞减少症、不受控制的糖尿病、某些肝脏疾病、肾功能不全、不受控制的甲状腺疾病或其他严重或不稳定疾病的参与者。
  • 在进入研究后 3 个月内接受过电休克疗法 (ECT) 或将在研究期间的任何时间接受 ECT 的参与者
  • 具有已知人类免疫缺陷病毒 (HIV) 阳性病史的参与者
  • (1) 丙型肝炎病毒抗体或 (2) 乙型肝炎表面抗原 (HBsAg) 检测呈阳性且伴有或不伴有乙型肝炎核心总抗体阳性的参与者
  • 在研究开始时校正 QT 间期（Bazett's；QTcB）>450 毫秒（男性）或 >470 毫秒（女性）的参与者

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：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Pomaglumetad methionil
Pomaglumetad methionil will be administered orally. Participants entering the study will be flexibly dosed between 20 milligrams (mg), 40 mg, or 80 mg twice daily.
药品：甲硫胺苯胺
口服给药
其他名称：
  • LY2140023

研究衡量的是什么？

主要结果指标

结果测量
大体时间
巴恩斯静坐不能量表 (BAS) 从基线到 5 年的分类变化
大体时间：基线，长达 5 年
基线，长达 5 年
辛普森-安格斯量表 (SAS) 从基线到 5 年的分类变化
大体时间：基线，长达 5 年
基线，长达 5 年
异常非自愿运动量表 (AIMS) 从基线到 5 年的分类变化
大体时间：基线，长达 5 年
基线，长达 5 年
从基线到 5 年体重发生临床显着变化的参与者比例
大体时间：长达 5 年的基线
长达 5 年的基线
催乳素水平从基线到 5 年的分类变化
大体时间：基线，长达 5 年
基线，长达 5 年
空腹血糖和血脂从基线到 5 年的分类变化
大体时间：基线，长达 5 年
基线，长达 5 年

次要结果测量

结果测量
大体时间
缺乏疗效的时间
大体时间：长达 5 年的基线
长达 5 年的基线
通过哥伦比亚自杀严重程度评定量表 (CSSRS) 测量的具有自杀行为和想法的参与者人数
大体时间：长达 5 年的基线
长达 5 年的基线
临床总体印象-严重程度 (CGI-S) 从基线到 5 年的变化
大体时间：基线，长达 5 年
基线，长达 5 年
简明精神病评定量表 (BPRS) 从基线到 5 年的变化
大体时间：基线，长达 5 年
基线，长达 5 年

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。

赞助

Denovo Biopharma LLC

调查人员

  • 研究主任：Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)、Eli Lilly and Company

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

2011年12月1日

初级完成 (实际的)

2012年10月1日

研究完成 (实际的)

2012年10月1日

研究注册日期

首次提交

2011年11月30日

首先提交符合 QC 标准的

2011年12月6日

首次发布 (估计的)

2011年12月7日

研究记录更新

最后更新发布 (实际的)

2026年9月14日

上次提交的符合 QC 标准的更新

2026年9月10日

最后验证

2022年10月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 12666
  • H8Y-MC-HBBV (其他标识符：Eli Lilly and Company)

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.

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