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一项关于精神分裂症的长期、开放标签研究

2026年9月10日更新者：Denovo Biopharma LLC

LY2140023 与非典型抗精神病药物治疗标准在 DSM-IV-TR 精神分裂症患者中的长期、开放标签、多中心研究

该研究的主要目的是帮助回答以下研究问题：

与 52 周时间段内的护理标准相比，精神分裂症患者对 LY 2140023 的耐受性如何。

LY 2140023是否可以帮助精神分裂症患者。

研究概览

地位

终止

条件

精神分裂症

干预/治疗

详细说明

该研究包括2个治疗期。研究期 I 将从患者随机化（入组研究 HBBO）开始，并持续到前 2 年的治疗。研究阶段 II 将仅针对随机接受 LY2140023 治疗的患者，并将在患者完成第二年的治疗后开始。有资格入组的患者将以 3:1 的比例（分别为 LY2140023 与标准治疗）随机分为 2 个治疗组：灵活的、每日两次剂量的 LY2140023 或标准治疗（奥氮平、利培酮、阿立哌唑或喹硫平）。如果研究人员认为合适，分配给 LY2140023 的人可以选择在 2 年后继续 LY2140023。

研究类型

介入性

注册 (实际的)

560

阶段

阶段2
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

乌克兰
- - Donetsk、乌克兰、83037
    - 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.
  - Kherson、乌克兰、73488
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  - Kiev、乌克兰、2660
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  - Vinnytsia、乌克兰、21005
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俄罗斯
- - Khot'kovo、俄罗斯、127025
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  - Lipetsk、俄罗斯、399007
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  - Moscow、俄罗斯、115522
    - 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.
  - Nizhny Novgorod、俄罗斯、603155
    - 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.
  - Saint Petersburg、俄罗斯、190121
    - 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.
  - Samara、俄罗斯、443016
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  - Saratov、俄罗斯、410060
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  - Tomsk、俄罗斯、634014
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  - Voronezh、俄罗斯、394071
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  - Yaroslavl、俄罗斯、150003
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克罗地亚
- - Zagreb、克罗地亚、10090
    - 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.
台湾
- - Changhua、台湾、50550
    - 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.
  - Neihu District、台湾、114
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  - Taipei、台湾、100
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墨西哥
- - Guadalajara、墨西哥、44340
    - 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.
  - Monterrey、墨西哥、64060
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日本
- - Aichi、日本、470-1168
    - 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.
  - Kanagawa、日本、210-0013
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  - Kumamoto、日本、861-0002
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  - Kyoto、日本、625-8502
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  - Nagano、日本、384-8540
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  - Nagasaki、日本、856-0847
    - 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.
  - Nara、日本、634-8522
    - 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.
  - Osaka、日本、569-1041
    - 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.
  - Saga、日本、842-0192
    - 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.
  - Tokyo、日本、120-0033
    - 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.
  - Toyama、日本、939-8073
    - 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
- - Ponce、波多黎各、00731
    - 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 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.
美国
- Arkansas
  - Little Rock、Arkansas、美国、72201
    - 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.
- California
  - 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.
  - National City、California、美国、91950
    - 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、California、美国、94612
    - 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.
  - Oceanside、California、美国、92056
    - 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.
  - Paramount、California、美国、90723
    - 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.
  - Pasadena、California、美国、91106
    - 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
  - Fort Lauderdale、Florida、美国、33308
    - 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.
  - Hollywood、Florida、美国、33021
    - 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.
  - Kissimmee、Florida、美国、34741
    - 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.
  - University Park、Florida、美国、34201
    - 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.
- Georgia
  - Atlanta、Georgia、美国、30308
    - 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.
  - Hoffman Estates、Illinois、美国、60169
    - 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、46222
    - 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.
- Kansas
  - Wichita、Kansas、美国、67207
    - 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.
  - Shreveport、Louisiana、美国、71104
    - 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.
- New York
  - Buffalo、New York、美国、14215
    - 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.
  - Holliswood、New York、美国、11423
    - 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、New York、美国、10032
    - 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.
- Ohio
  - Cincinnati、Ohio、美国、45219
    - 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.
  - Dayton、Ohio、美国、45417
    - 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
  - 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.
  - Dallas、Texas、美国、75243
    - 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.
  - Houston、Texas、美国、77008
    - 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、23298
    - 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.
  - Roanoke、Virginia、美国、24014
    - 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.
韩国
- - Goyang-si、韩国、410-719
    - 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.
  - Incheon、韩国、400-711
    - 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.
  - Naju、韩国、520-833
    - 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.
  - Seoul、韩国、150-713
    - 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.
  - Suwon、韩国、442-723
    - 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.
  - Yongin、韩国、446-769
    - 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：

必须满足并完成 LY2140023 的急性安慰剂对照临床试验（例如研究 H8Y-MC-HBBM，或其他急性安慰剂对照 LY2140023 研究，如果这些研究的方案允许） .
有生育能力的女性患者必须同意使用单一、有效、医学上可接受的节育方法。
患者必须被认为是可靠的，并且具有足以执行协议要求的所有测试和检查的理解水平。
患者必须能够理解研究的性质，并给出自己的知情同意书。

排除标准：

目前正在参加涉及研究产品或未经批准使用药物或设备（LY2140023 除外）的临床试验，或在过去 30 天内中止，或同时参加任何其他类型的医学研究，这些研究被认为不是科学或医学上与本研究相容。
根据本方案规定，奥氮平、利培酮、阿立哌唑、喹硫平或 LY2140023 治疗相对或绝对临床禁忌的患者。
在参加研究之前的 12 个月内接受过剂量大于每天 200 毫克的氯氮平治疗的患者，或者在参加研究之前的一个月内接受过任何氯氮平治疗的患者。
需要与任何其他具有主要中枢神经系统活性的药物同时治疗的患者，研究方案允许的药物除外。
患者有自杀的危险。
在研究入组前 6 个月内被诊断患有物质依赖或物质滥用的患者。
在研究登记后 7 天内或在研究期间的任何时间被诊断患有物质诱发精神病的患者。
怀孕、哺乳、哺乳或打算在完成研究后 30 天内怀孕的女性患者。
已知青光眼。
有某些类型癫痫发作的病史。
癫痫发作的可能性与已完成的急性饲养研究的排除标准不一致。
在研究登记后 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 的患者。
具有已知人类免疫缺陷病毒阳性 (HIV+) 状态的患者。
患者有严重疾病，如近期中风、心脏、肝脏、肾脏、肺部或血液疾病
帕金森病患者
无法参与研究或不愿意作为研究参与者以有意义的方式参与。

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：无（打开标签）

手臂数量

武器和干预

参与者组/臂	干预/治疗
有源比较器：护理标准	药品：奥氮平片剂或胶囊，口服，符合批准的标签和当地惯例 104 周其他名称：再普乐 LY170053 药品：阿立哌唑片剂或胶囊，口服，符合批准的标签和当地惯例 104 周药品：利培酮片剂或胶囊，口服，符合批准的标签和当地惯例 104 周药品：喹硫平片剂或胶囊，口服，符合批准的标签和当地惯例 104 周
实验性的：LY2140023 20 milligram (mg), 40mg or 80mg After 104 weeks, participants have the option to continue on treatment until the end of the study	药品：LY2140023 口服给药，每天两次，持续 104 周其他名称： metabotropic glutamate (mGlu) 2/3 Prodrug II

参与者组/臂

干预/治疗

有源比较器：护理标准

药品：奥氮平

片剂或胶囊，口服，符合批准的标签和当地惯例 104 周

其他名称：

再普乐
LY170053

药品：阿立哌唑

片剂或胶囊，口服，符合批准的标签和当地惯例 104 周

药品：利培酮

片剂或胶囊，口服，符合批准的标签和当地惯例 104 周

药品：喹硫平

片剂或胶囊，口服，符合批准的标签和当地惯例 104 周

实验性的：LY2140023

20 milligram (mg), 40mg or 80mg

After 104 weeks, participants have the option to continue on treatment until the end of the study

药品：LY2140023

口服给药，每天两次，持续 104 周

其他名称：

metabotropic glutamate (mGlu) 2/3 Prodrug II

研究衡量的是什么？

主要结果指标

结果测量	大体时间
因不良事件停药的时间大体时间：基线至 52 周	基线至 52 周

次要结果测量

结果测量	大体时间
PANSS（阳性和阴性综合症量表）中从基线到 52 周终点的变化大体时间：基线，52 周	基线，52 周
临床整体印象-严重程度 (CGI-S) 从基线到 52 周终点的变化大体时间：基线，52 周	基线，52 周
NSA-16（16 项阴性症状评估）中从基线到 52 周终点的变化大体时间：基线，52 周	基线，52 周
基于 Columbia Suicide Severity Rating Scale (C-SSRS)，具有统计学显着变化（治疗紧急想法和行为；改善）的患者数量大体时间：52周、104周、研究结束	52周、104周、研究结束
PSP 量表（个人和社会绩效）从基线到 52 周终点的变化大体时间：基线，52 周	基线，52 周
SWN 量表（抗精神病药治疗下的主观幸福感）从基线到 52 周终点的变化大体时间：基线，52 周	基线，52 周
精神分裂症资源使用模型 (S-RUM) 从基线到 104 周终点的变化大体时间：基线，104 周	基线，104 周
EuroQoL Questionnaire-5 维度 (EQ-5D) 从基线到 104 周终点的变化大体时间：基线，104 周	基线，104 周
PANSS（阳性和阴性症状量表）中的终点从 52 周变为 104 周大体时间：52周、104周	52周、104周
Clinical Global Impression-Severity (CGI-S) 终点从 52 周变为 104 周大体时间：52周、104周	52周、104周
NSA-16（16 项阴性症状评估）中终点从 52 周变为 104 周大体时间：52周、104周	52周、104周
从第 104 周到临床整体印象-严重性 (CGI-S) 研究终点的变化大体时间：104 周，研究结束	104 周，研究结束
PSP 量表（个人和社会绩效）从基线到 104 周终点的变化大体时间：基线，104 周	基线，104 周
SWN 量表（精神安定药治疗下的主观幸福感）从基线到 104 周终点的变化大体时间：基线，104 周	基线，104 周
精神分裂症资源使用模型 (S-RUM) 从基线到 52 周终点的变化大体时间：基线，52 周	基线，52 周
EuroQoL Questionnaire-5 Dimension (EQ-5D) 中从 104 周到研究终点的变化大体时间：104 周，研究结束	104 周，研究结束
在基因定义的亚组中，PANSS（阳性和阴性综合症量表）从基线到 52 周终点的变化大体时间：基线，52 周	基线，52 周

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

2010年6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

2010年5月21日

首先提交符合 QC 标准的

2010年5月21日

首次发布 (估计的)

2010年5月25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

一项关于精神分裂症的长期、开放标签研究

LY2140023 与非典型抗精神病药物治疗标准在 DSM-IV-TR 精神分裂症患者中的长期、开放标签、多中心研究

研究概览

地位

条件

干预/治疗

详细说明

研究类型

注册 (实际的)

阶段

联系人和位置

学习地点

参与标准

资格标准

适合学习的年龄

接受健康志愿者

描述

学习计划

研究是如何设计的？

设计细节

手臂数量

武器和干预

参与者组/臂

干预/治疗

研究衡量的是什么？

主要结果指标

结果测量

大体时间

次要结果测量

结果测量

大体时间

合作者和调查者

赞助

调查人员

研究记录日期

研究主要日期

学习开始

初级完成 (实际的)

研究完成 (实际的)

研究注册日期

首次提交

首先提交符合 QC 标准的

首次发布 (估计的)

研究记录更新

最后更新发布 (实际的)

上次提交的符合 QC 标准的更新

最后验证

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号