精神分裂症靶向认知训练的美金刚增强
2026年4月24日 更新者：Gregory Light、University of California, San Diego
精神分裂症的治疗目前包括抗精神病药物和改善某些症状的认知疗法，但不能充分恢复认知功能或减少社会心理障碍。
我们假设专门针对感觉信息处理缺陷而非精神病症状本身的药物将显着增强精神分裂症患者基于感觉的靶向认知训练 (TCT) 干预的益处。
我们将完成一项随机、双盲临床试验，以：1) 确认药物美金刚增强 TCT 学习； 2) 确定美金刚是否增强抗精神病药物治疗的精神分裂症患者中 TCT 与 TCT 加安慰剂的完整 30 个疗程的临床益处，以及 3) 确定美金刚对 TCT 的增强是否在生物标志物定义的患者亚组中最有效。
研究概览
详细说明
精神分裂症 (SZ) 的治疗目前包括抗精神病药物和改善某些症状的认知疗法，但不能充分恢复认知功能或减少社会心理障碍。
我们提出并将测试一种新的“增强策略”，用于使用药物来专门增强精神分裂症中靶向认知训练 (TCT) 的益处。
该项目测试了一个合理且经验支持的平台，该平台通过每天辅助治疗 20 mg 美金刚（一种 FDA 批准的用于治疗阿尔茨海默病认知功能障碍的药物）来增加 TCT 在接受抗精神病药物治疗的 SZ 患者中的益处。
我们假设专门针对感觉信息处理缺陷而非精神病症状本身的药物将显着增强精神分裂症患者基于感觉的靶向认知训练 (TCT) 干预的益处。
我们将完成一项随机、双盲临床试验，以：1) 确认药物美金刚增强 TCT 学习； 2) 确定美金刚是否增强抗精神病药物治疗的精神分裂症患者中 TCT 与 TCT 加安慰剂的完整 30 个疗程的临床益处，以及 3) 确定美金刚对 TCT 的增强是否在生物标志物定义的患者亚组中最有效。
研究类型
介入性
注册 (实际的)
62
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
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California
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San Diego、California、美国、92103
- Clinical Teaching Facility (CTF B-403 at UCSD Medical Center)
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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
18年 至 65年 (成人、年长者)
接受健康志愿者
不
描述
纳入标准：
- DSM-IV 精神分裂症或分裂情感障碍的诊断
- 参与研究的书面知情同意书
- 18-65岁
- 没有痴呆或精神发育迟滞
- 娱乐性药物的尿液毒理学阴性
- 英语流利且识字
排除标准：
- 符合当前物质滥用或依赖的 DSM-IV 标准，并且已戒除物质少于 30 天
- 外伤性脑损伤史
- 严重到足以阻止研究参与的听觉或视觉障碍
- 在监管下（由 Anasazi 决定）
- 怀孕
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
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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安慰剂比较：TCT+PBO
受试者将被分配服用安慰剂，并完成 30 小时的有针对性的认知训练，以评估美金刚是否能增强认知训练表现
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受试者将被分配服用美金刚或安慰剂，并完成 30 小时的有针对性的认知训练，以评估美金刚是否增强认知训练表现
其他名称：
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有源比较器：TCT+MEM
受试者将被分配服用美金刚，并完成 30 小时的有针对性的认知训练，以评估美金刚是否能增强认知训练表现
|
受试者将被分配服用美金刚或安慰剂，并完成 30 小时的有针对性的认知训练，以评估美金刚是否增强认知训练表现
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Positive & Negative Symptom Scale Total (PANSSt)
大体时间：Baseline (at study enrollment), post-10 TCT sessions (approximately week 10), post-20 TCT sessions (approximately week 13) and post-30 TCT sessions (approximately week 16).
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PANSS Total Score is the primary clinical outcome measured at baseline vs. post TCT session 10, 20 and 30 (approximately 16 weeks).
The PANSS total score has a range 30-210, with higher scores indicating worse outcome.
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Baseline (at study enrollment), post-10 TCT sessions (approximately week 10), post-20 TCT sessions (approximately week 13) and post-30 TCT sessions (approximately week 16).
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World Health Organization Disability Schedule (WHODAS 2.0)
大体时间：Baseline (at study enrollment), post-10 TCT sessions (approximately week 10), post-20 TCT sessions (approximately week 13) and post-30 TCT sessions (approximately week 16).
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Function will be assessed via the World Health Organization Disability Schedule 2.0 (WHODAS 2.0) at baseline vs. post-TCT session 10, 20 and 30 (approximately 16 weeks).
The World Health Organization Disability Schedule (WHODAS 2.0) has a range 12-60, with higher scores indicating worse outcome.
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Baseline (at study enrollment), post-10 TCT sessions (approximately week 10), post-20 TCT sessions (approximately week 13) and post-30 TCT sessions (approximately week 16).
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MATRICS Consensus Cognitive Battery Global Composite T-score (MCCB-C)
大体时间：Baseline (at study enrollment), post-10 TCT sessions (approximately week 10), post-20 TCT sessions (approximately week 13) and post-30 TCT sessions (approximately week 16).
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The MCCB Global Composite T-score (MCCB-C) is the primary neurocognitive outcome measured at baseline vs. post-TCT session 10, 20 and 30 (approximately 16 weeks).
The MATRICS Consensus Cognitive Battery (MCCB) composite T-score has no minimum or maximum score because it uses T-scores (e.g., 50 indicates the population mean with a standard deviation of 10), which are standardized based on a community sample.
A normal range MCCB composite T-score is between 40 and 60 and higher scores indicate better neurocognitive outcome.
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Baseline (at study enrollment), post-10 TCT sessions (approximately week 10), post-20 TCT sessions (approximately week 13) and post-30 TCT sessions (approximately week 16).
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Positive & Negative Symptom Scale (PANSS) - Positive Symptom Subscale
大体时间：Baseline (at study enrollment), post-10 TCT sessions (approximately week 10), post-20 TCT sessions (approximately week 13) and post-30 TCT sessions (approximately week 16).
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Positive & Negative Symptom Scale (PANSS) positive symptom subscale measured at baseline vs. post-TCT session 10, 20 and 30 (approximately 16 weeks).
The PANSS positive symptom subscale is rated from 1 to 7 points ranging from absent to extreme.
The range for the Positive Symptom subscale is 7-49 and higher scores indicate worse outcome.
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Baseline (at study enrollment), post-10 TCT sessions (approximately week 10), post-20 TCT sessions (approximately week 13) and post-30 TCT sessions (approximately week 16).
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Positive & Negative Symptom Scale (PANSS) - Negative Symptom Subscale
大体时间：Baseline (at study enrollment), post-10 TCT sessions (approximately week 10), post-20 TCT sessions (approximately week 13) and post-30 TCT sessions (approximately week 16).
|
Positive & Negative Symptom Scale (PANSS) negative symptom subscale measured at baseline vs. post-TCT session 10, 20 and 30 (approximately 16 weeks).
The PANSS negative symptom subscale is rated from 1 to 7 points ranging from absent to extreme.
The range for the negative symptom subscale is 7-49 and higher scores indicate worse outcome.
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Baseline (at study enrollment), post-10 TCT sessions (approximately week 10), post-20 TCT sessions (approximately week 13) and post-30 TCT sessions (approximately week 16).
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Psychotic Symptoms - PSYRATS Hallucination Subscale
大体时间：Baseline (at study enrollment), post-10 TCT sessions (approximately week 10), post-20 TCT sessions (approximately week 13) and post-30 TCT sessions (approximately week 16).
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Psychotic Symptom Rating Scales (PSYRATS hallucination subscale) measured at baseline vs. post-TCT session 10, 20 and 30 (approximately 16 weeks).
The PSYRATS auditory hallucinations subscale (AHS) consisting of 11 items, with each item being rated from 0 (absent) to 4 (severe), range 0-44, with higher scores indicating more severe auditory hallucinations or worse outcome.
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Baseline (at study enrollment), post-10 TCT sessions (approximately week 10), post-20 TCT sessions (approximately week 13) and post-30 TCT sessions (approximately week 16).
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Manic Symptoms - Young Mania Rating Scale
大体时间：Baseline (at study enrollment), post-10 TCT sessions (approximately week 10), post-20 TCT sessions (approximately week 13) and post-30 TCT sessions (approximately week 16).
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Young Mania Rating Scale total score measured at baseline vs. post-TCT session 10, 20 and 30 (approximately 16 weeks).
The range for the YMRS total score is 0-60, with higher scores indicating more severe manic symptoms or worse outcome.
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Baseline (at study enrollment), post-10 TCT sessions (approximately week 10), post-20 TCT sessions (approximately week 13) and post-30 TCT sessions (approximately week 16).
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Current Depressive Symptoms - PHQ-9
大体时间：Baseline (at study enrollment), post-10 TCT sessions (approximately week 10), post-20 TCT sessions (approximately week 13) and post-30 TCT sessions (approximately week 16).
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Patient Health Questionnaire-9 (PHQ-9) total score measured at baseline vs. post-TCT session 10, 20 and 30 (approximately 16 weeks).
The PHQ-9 has a range from 0 to 27 with higher scores indicating more severe depression or worse outcome.
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Baseline (at study enrollment), post-10 TCT sessions (approximately week 10), post-20 TCT sessions (approximately week 13) and post-30 TCT sessions (approximately week 16).
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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。
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 (实际的)
2021年7月6日
初级完成 (实际的)
2025年3月30日
研究完成 (实际的)
2025年3月30日
研究注册日期
首次提交
2021年4月21日
首先提交符合 QC 标准的
2021年4月21日
首次发布 (实际的)
2021年4月23日
研究记录更新
最后更新发布 (实际的)
2026年5月18日
上次提交的符合 QC 标准的更新
2026年4月24日
最后验证
2026年4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.