一项针对精神分裂症患者的研究
2026年9月10日 更新者：Denovo Biopharma LLC
LY2140023 在 DSM-IV 精神分裂症患者中的多中心、住院、2 期、双盲、安慰剂对照剂量范围研究
本研究的目的是检验以下假设：精神分裂症患者口服 1 个或多个剂量水平的 LY2140023，每天两次，持续 4 周，效果明显优于安慰剂。
研究概览
详细说明
The primary objective of this study was to test the hypothesis that 1 or more dose levels of LY2140023 given orally to patients with schizophrenia twice daily for 4 weeks would demonstrate significantly greater efficacy than placebo. Efficacy was defined as clinical response measured by the Positive and Negative Syndrome Scale (PANSS) total score as assessed at 4 weeks.
This was a multi-center, randomized, double-blind, parallel, placebo- and active comparator-controlled trial with 4 study periods. Approximately 870 patients who met the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV, APA 2000) criteria for schizophrenia as defined by the modified Structured Clinical Interview for DSM-IV Diagnosis (SCID) were to be entered into the study so that approximately 550 patients would be considered evaluable (that is, randomized patients with a baseline and at least 1 postbaseline PANSS total score following study treatment). Male and female patients aged 18 to 65 years who qualified for enrollment into the study were randomized in a 2:2:2:2:2:1 ratio to receive 5 mg, 20 mg, 40 mg, or 80 mg twice daily LY2140023, placebo twice daily, or placebo once each morning and 15 mg olanzapine once each evening for approximately 28 days.
研究类型
介入性
注册 (实际的)
669
阶段
- 阶段2
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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Kazan'、俄罗斯、420012
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Khot'kovo、俄罗斯、127025
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Lipetsk、俄罗斯、399007
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Moscow、俄罗斯、123367
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Nikol’skoye、俄罗斯、188357
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Nizhny Novgorod、俄罗斯、603155
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Saint Petersburg、俄罗斯、190121
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Samara、俄罗斯、443016
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Osijek、克罗地亚、HR-31000
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Split、克罗地亚、21000
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Zagreb、克罗地亚、HR-10090
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Bloemfontein、南非、9300
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Cape Town、南非、7530
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Durban、南非、4000
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Johannesburg、南非、2198
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Pretoria、南非、0181
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Randburg、南非、2125
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Mexico City、墨西哥、14420
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Monterrey、墨西哥、64000
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Graz、奥地利、8036
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Vienna、奥地利、1090
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Aachen、德国、D-52057
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Bochum、德国、44791
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Dresden、德国、01307
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München、德国、D-81675
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Bucharest、罗马尼亚、73120
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Craiova、罗马尼亚、200738
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Iași、罗马尼亚、700282
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Târgu Mureş、罗马尼亚、540139
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Lisbon、葡萄牙、1350-190
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Porto、葡萄牙、4200-272
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Banfield、阿根廷、B1828CKR
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Buenos Aires、阿根廷、C1424CAB
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Lanus、阿根廷、B18241BR
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Munro、阿根廷、1605
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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
14年 至 61年 (成人、年长者)
接受健康志愿者
不
描述
一些纳入标准：
- 患者必须诊断为精神疾病诊断和统计手册第四版 (DSM-IV) 中定义的精神分裂症（无序，295.10； 紧张症，295.20； 偏执狂，295.30； 残差，295.60；或未分化，295.90）并通过 DSM-IV 的结构化临床访谈 (SCID) 确认。
- 患者在第 1 次就诊时必须满足以下精神病理学严重性标准： 从阳性和阴性症状量表 (PANSS) 中提取的简明精神病评定量表 (BPRS) 总分至少为 45（18 项版本，其中 1 表示“不存在” ”，7 表示“严重”）。 此外，以下 BPRS 项目中的 2 项至少需要 4 分（中等）：概念混乱、多疑、幻觉行为和/或不寻常的思想内容。
- 患者必须在第 1 次就诊时获得 4 分（中度疾病）或更高的临床整体印象-严重程度 (CGI-S) 评分。
- 根据研究者的意见，患者急需换用另一种抗精神病药物或开始使用抗精神病药物。
一些排除标准：
- 奥氮平或安慰剂治疗相对或绝对临床禁忌的患者。
- 研究者认为对奥氮平充分治疗试验反应不足的患者。
- 在访问 1 之前的 6 周内接受过奥氮平治疗的患者。
- 在第 1 次就诊前 12 个月内接受过每日剂量大于 200 mg 的氯氮平治疗的患者，或在第 1 次就诊前一个月内接受过任何氯氮平治疗的患者。
- 根据研究者的意见，在访问 1 之前的过去 12 个月内，对 2 次或更多次持续至少 8 周的充分抗精神病药物试验有不充分反应史的患者。
- 患有急性、严重或不稳定医疗状况的患者，包括（但不限于）糖尿病控制不佳（糖化血红蛋白（HbA1c）8%）、严重高甘油三酯血症（空腹甘油三酯 5.6 mmol/L、近期脑血管意外、严重急性全身感染或免疫性疾病、不稳定的心血管疾病（包括缺血性心脏病）、营养不良、肝病、肾病、胃肠病、呼吸病、内分泌病、神经病或血液病。
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：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
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安慰剂比较：Placebo for LY2140023
Placebo for LY2140023 taken orally twice daily for up to 4 weeks.
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口服给药
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实验性的：10 mg LY2140023
10 milligram (mg) LY2140023 taken orally as 5 mg twice daily for up to 4 weeks.
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口服给药
其他名称：
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实验性的：40 mg LY2140023
40 mg LY2140023 taken orally as 20 mg twice daily for up to 4 weeks.
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口服给药
其他名称：
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实验性的：80 mg LY2140023
80 mg LY2140023 taken orally as 40 mg twice daily for up to 4 weeks.
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口服给药
其他名称：
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实验性的：160 mg LY2140023
160 mg LY2140023 taken orally as 80 mg twice daily for up to 4 weeks.
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口服给药
其他名称：
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有源比较器：Placebo/15 mg Olanzapine
Placebo: Taken orally every morning (QAM), followed by Olanzapine 15 mg taken orally every evening (QPM) for up to 4 weeks. Olanzapine: 10 mg PO (by mouth) QPM for the first 3 days, then 15mg PO QPM for up to 4 weeks. |
口服给药
Administered orally
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
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阳性和阴性症状量表（PANSS）总分
大体时间：超过 4 周的治疗
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超过 4 周的治疗
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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PANSS 子分数：正子分数；负分数；一般精神病理学子分数和认知子分数
大体时间：超过 4 周的治疗
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超过 4 周的治疗
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临床整体印象-严重程度 (CGI-S)
大体时间：超过 4 周的治疗
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超过 4 周的治疗
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药物态度量表 10 (DAI-10)
大体时间：超过 4 周的治疗
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超过 4 周的治疗
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缓解率和缓解率
大体时间：超过 4 周的治疗
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超过 4 周的治疗
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精神分裂症认知评估 (BACS) 符号编码任务
大体时间：超过 4 周的治疗
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超过 4 周的治疗
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蒙哥马利-阿斯伯格抑郁量表 (MADRS)
大体时间：超过 4 周的治疗
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超过 4 周的治疗
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安全性和耐受性
大体时间：超过 4 周的治疗
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超过 4 周的治疗
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药代动力学
大体时间：超过 4 周的治疗
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超过 4 周的治疗
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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。
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
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。
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
2007年9月1日
初级完成 (实际的)
2008年10月1日
研究完成 (实际的)
2008年10月1日
研究注册日期
首次提交
2007年8月24日
首先提交符合 QC 标准的
2007年8月24日
首次发布 (估计的)
2007年8月27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8月1日
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
- 11757
- H8Y-MC-HBBI (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.