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预测 PTSD 退伍军人的 SSRI 疗效 (SSRI)

2026年5月26日 更新者：VA Office of Research and Development

PTSD 退伍军人 SSRI 反应的电生理预测因子

这是一项研究，旨在检验一种简短筛选方法的有效性，该方法可以预测哪些患有创伤后应激障碍 (PTSD) 或抑郁症的人最有可能对选择性 5-羟色胺再摄取抑制剂 (SSRI) 药物产生积极反应。 将在大约 5.25 年内招募参与者，直到至少 94 名参与者完成为期 17 周的研究。

研究概览

地位

终止

条件

干预/治疗

详细说明

在退伍军人健康管理局 (VHA) 中，大约 60% 的患有 PTSD 的退伍军人被开具了选择性血清素再摄取抑制剂 (SSRI)。 然而，许多患者对 SSRIs 没有反应。 目前，无法确定特定患者是否会从 SSRI 中受益；治疗主要通过数周或数月的“反复试验”来完成。 本研究的首要目标是调查治疗前使用简单电生理测试预测对 SSRI 产生良好反应的可能性的有用性。 这项研究将调查一个简短的治疗前听觉事件相关电位程序 [被称为“听觉诱发电位的响度依赖性”（LDAEP）] 是否提供了一种方法来预测诊断为男性和女性对 SSRI 的治疗反应创伤后应激障碍或抑郁症。

本研究有四个目的：1) 确定 LDAEP 与 SSRI 治疗的临床反应之间关系的强度。 2) 确定 LDAEP 临界值，使临床医生能够提出个性化的 SSRI 治疗建议。 3) 评估 LDAEP 变化作为 SSRI 反应的客观衡量标准的有用性。 4) 探索性：确定 LDAEP 与舍曲林临床反应之间的关系在男性和女性之间是否存在差异。

保护对象身份的方法：

为确保机密性，调查问卷和访谈数据将存储在上锁办公室的上锁文件柜中。 每个参与者都将拥有自己的参与者编号，这些编号将是识别参与者信息的唯一方式。 电子数据将存储在受密码保护的安全私人驱动器上，该驱动器只能由研究团队成员访问，并且仅标有参与者编号。 一份姓名和参与者编号列表将保存在一个私人的、受密码保护的计算机帐户中，该帐户位于与去识别化数据不同的驱动器上，并且只有研究团队可以访问。

非 NIH 资助的研究药物管理 药物鉴定说明：舍曲林。 由于本研究的目标是确定最终可用于常规临床护理的 SSRI 反应的治疗前预测因子，因此研究人员在设计该研究时考虑了生态有效性。 具体而言，研究人员选择舍曲林作为研究药物，因为它是：a) 美国最常用的 SSRI，b) FDA 批准的两种治疗 PTSD 的药物之一，以及 c) 两种最有效的 SSRI 之一重度抑郁症是 PTSD 的常见合并症。 剂量将遵循临床实践指南，即，将根据临床反应和耐受性选择剂量。

药物管理说明：研究人员正在使用一种方法，该方法代表了增强的临床护理，因为参与者每两周与精神科医生讨论药物水平、副作用和症状。 研究药物和安慰剂将由 VA Boston Pharmacy 服务存储和分发。

研究类型

介入性

注册 (实际的)

19

阶段

  • 第四阶段

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

  • 美国
    • Massachusetts
      • Boston、Massachusetts、美国、02130-4817
        • VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
    • South Carolina
      • Charleston、South Carolina、美国、29401-5703
        • Ralph H. Johnson VA Medical Center, Charleston, SC

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 75年 (成人、年长者)

接受健康志愿者

不

描述

纳入标准：

  1. 有 DSM-5 中 PTSD 标准 A 定义的创伤暴露史
  2. 符合 DSM-5 定义的 PTSD、亚阈值 PTSD 或 MDD 的诊断标准
  3. 研究精神科医生的判断，即 SSRIs 是参与者当前问题的可接受治疗选择，以及
  4. 有兴趣开始试用 SSRI

排除标准：

  • I型双相情感障碍、精神分裂症或其他精神障碍的当前或过去病史
  • 目前的器质性脑部疾病，包括严重的创伤性脑损伤、做作性障碍或装病
  • 怀孕
  • 主要的神经问题
  • 当前中度或重度物质使用障碍
  • 对自己或他人的主动风险
  • 有临床意义的肝脏或肾脏疾病或任何其他可能干扰研究安全进行的急性或不稳定医学状况的证据
  • 对舍曲林不耐受或过敏
  • 过去舍曲林试验失败（通过病历审查确认）
  • 在研究后 3 个月内使用直接影响血清素系统的药物（例如 SNRIs、抗精神病药）
  • 在研究后 3 个月内使用 SSRI。 其他精神药物的使用必须在入组前稳定 3 个月，并在整个参与过程中保持稳定
  • 780 Hz 音调的听力损伤
  • 目前参加以创伤为中心的心理治疗

  • 对于那些目前有非 VA 或 VA 精神科医生或初级保健提供者愿意开药的参与者，他们必须愿意签署信息发布 (ROI)，以便研究人员与他们的提供者沟通，并且提供者认为包括参与者参与研究可能是合适的。

    • 如上所述，研究人员将告知参与者，研究人员将与他们当前的相关护理提供者分享以下信息：

      • 有关研究设计的信息、纳入和排除标准、参与者的精神病学和医学诊断以及疾病严重程度（在筛选评估中评估），以及任何安全问题的历史，例如对自己或他人的风险。
      • 如果参与者未签署信息发布 (ROI) 协议以联系提供者，则参与者将不会进入活动研究。

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：放映
  • 分配：非随机化
  • 介入模型：顺序分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
安慰剂比较：只有安慰剂的手臂
对于在 2 周安慰剂先导阶段是安慰剂反应者的个体，他们将在研究期间继续服用安慰剂（即，安慰剂无反应者服用舍曲林的 12 周）。
诊断测试：低密度脂蛋白
这是一项 ERP 任务，参与者会听到一系列范围从 74dB 到 104dB 的音调，并在整个过程中测量电生理活动。 对于每个参与者，平均 P2 分数是针对 74dB 音调、84dB 音调、94dB 音调和 104dB 音调得出的。 然后，LDAEP 被定义为这些平均 P2 分数的斜率。
药品：安慰剂
将给予与活性药物相同大小、颜色和味道的安慰剂药丸
有源比较器：舍曲林手臂
在为期 2 周的安慰剂导入阶段后，安慰剂无反应者将每天接受舍曲林 25 mg，持续 2 周。 此后，根据临床反应和耐受性，舍曲林每天灵活增加 25 至 50 毫克（每周不超过 50 毫克），以达到 50 至 200 毫克的总日剂量，最大剂量为200 毫克/天。 无法耐受更高剂量的受试者可能会回到之前的剂量，并在研究的剩余部分保持该剂量。
诊断测试：低密度脂蛋白
这是一项 ERP 任务，参与者会听到一系列范围从 74dB 到 104dB 的音调，并在整个过程中测量电生理活动。 对于每个参与者，平均 P2 分数是针对 74dB 音调、84dB 音调、94dB 音调和 104dB 音调得出的。 然后，LDAEP 被定义为这些平均 P2 分数的斜率。
药品：安慰剂
将给予与活性药物相同大小、颜色和味道的安慰剂药丸
药品：舍曲林
舍曲林是 FDA 批准的用于治疗 PTSD 的 SSRI。
其他名称：
  • 左洛复

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
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) After 14 Weeks of the Medication Trial Predicted by Pretreatment LDAEP Slope (Calculated With P200 at the PZ Site) and Controlling for Baseline CAPS Score
大体时间：CAPS score administered 14 weeks after starting the medication trial, controlling for baseline CAPS score
The CAPS-5 is the "gold standard" clinical interview for assessing PTSD. This measure will be used to characterize the sample regarding PTSD diagnosis and as a measure of PTSD severity. Each of the 20 symptoms of PTSD included in DSM-5 is rated on a 5-point scale ranging from 0-4, with a 0 or 1 indicating that the symptom is absent or subthreshold and a score of 2-4 indicating that a symptom has reached the threshold to be included as a symptom and ranges in severity from moderate to extreme. The total range of the CAPS-5 is 0-80, higher scores indicating higher symptom severity.
CAPS score administered 14 weeks after starting the medication trial, controlling for baseline CAPS score
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) After 14 Weeks of the Medication Trial as Predicted by Pretreatment LDAEP Slope (Calculated With P200 at the CZ Site) and Controlling for Baseline CAPS Score
大体时间：CAPS score administered 14 weeks after starting the medication trial, controlling for baseline CAPS score
The CAPS-5 is the "gold standard" clinical interview for assessing PTSD. This measure will be used to characterize the sample regarding PTSD diagnosis and as a measure of PTSD severity. Each of the 20 symptoms of PTSD included in DSM-5 is rated on a 5-point scale ranging from 0-4, with a 0 or 1 indicating that the symptom is absent or subthreshold and a score of 2-4 indicating that a symptom has reached the threshold to be included as a symptom and ranges in severity from moderate to extreme. The total range of the CAPS-5 is 0-80, higher scores indicating higher symptom severity.
CAPS score administered 14 weeks after starting the medication trial, controlling for baseline CAPS score
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) After 14 Weeks of the Medication Trial as Predicted by Pretreatment LDAEP Slope (Calculated With P200 at the FZ Site) and Controlling for Baseline CAPS Score
大体时间：CAPS score administered 14 weeks after starting the medication trial, controlling for baseline CAPS score
The CAPS-5 is the "gold standard" clinical interview for assessing PTSD. This measure will be used to characterize the sample regarding PTSD diagnosis and as a measure of PTSD severity. Each of the 20 symptoms of PTSD included in DSM-5 is rated on a 5-point scale ranging from 0-4, with a 0 or 1 indicating that the symptom is absent or subthreshold and a score of 2-4 indicating that a symptom has reached the threshold to be included as a symptom and ranges in severity from moderate to extreme. The total range of the CAPS-5 is 0-80, higher scores indicating higher symptom severity.
CAPS score administered 14 weeks after starting the medication trial, controlling for baseline CAPS score
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) After 14 Weeks of the Medication Trial Predicted by Pretreatment LDAEP Slope (Calculated With N100 at the PZ Site) and Controlling for Baseline CAPS Score
大体时间：CAPS score administered 14 weeks after starting the medication trial, controlling for baseline CAPS score
The CAPS-5 is the "gold standard" clinical interview for assessing PTSD. This measure will be used to characterize the sample regarding PTSD diagnosis and as a measure of PTSD severity. Each of the 20 symptoms of PTSD included in DSM-5 is rated on a 5-point scale ranging from 0-4, with a 0 or 1 indicating that the symptom is absent or subthreshold and a score of 2-4 indicating that a symptom has reached the threshold to be included as a symptom and ranges in severity from moderate to extreme. The total range of the CAPS-5 is 0-80, higher scores indicating higher symptom severity.
CAPS score administered 14 weeks after starting the medication trial, controlling for baseline CAPS score
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) After 14 Weeks of the Medication Trial Predicted by Pretreatment LDAEP Slope (Calculated With N100 at the CZ Site) and Controlling for Baseline CAPS Score
大体时间：CAPS score administered 14 weeks after starting the medication trial, controlling for baseline CAPS score
The CAPS-5 is the "gold standard" clinical interview for assessing PTSD. This measure will be used to characterize the sample regarding PTSD diagnosis and as a measure of PTSD severity. Each of the 20 symptoms of PTSD included in DSM-5 is rated on a 5-point scale ranging from 0-4, with a 0 or 1 indicating that the symptom is absent or subthreshold and a score of 2-4 indicating that a symptom has reached the threshold to be included as a symptom and ranges in severity from moderate to extreme. The total range of the CAPS-5 is 0-80, higher scores indicating higher symptom severity.
CAPS score administered 14 weeks after starting the medication trial, controlling for baseline CAPS score

次要结果测量

结果测量
措施说明
大体时间
Quick Inventory of Depressive Symptomatology- Self Report (QIDS-SR) as Predicted by Pretreatment LDAEP Slope (Calculated With P200 at the PZ Site)
大体时间：Administered at weeks 0, 2, 4, 6, 8, 10, 12, and 14
The QIDS-SR was used to measure the severity of depressive symptoms. The QIDS provides equivalent weightings (0-3) for each symptom item, gives clearly stated anchors that estimate the frequency and severity of symptoms, and includes all items required to diagnose a major depressive episode. The range for the total QIDS-SR severity score is 0-42, with higher scores indicating worse depression severity.
Administered at weeks 0, 2, 4, 6, 8, 10, 12, and 14
Quick Inventory of Depressive Symptomatology- Self Report (QIDS-SR) as Predicted by Pretreatment LDAEP Slope (Calculated With P200 at the CZ Site)
大体时间：Administered at weeks 0, 2, 4, 6, 8, 10, 12, and 14
The QIDS-SR was used to measure the severity of depressive symptoms. The QIDS provides equivalent weightings (0-3) for each symptom item, gives clearly stated anchors that estimate the frequency and severity of symptoms, and includes all items required to diagnose a major depressive episode. The range for the total QIDS-SR severity score is 0-42, with higher scores indicating worse depression severity.
Administered at weeks 0, 2, 4, 6, 8, 10, 12, and 14
Quick Inventory of Depressive Symptomatology- Self Report (QIDS-SR) as Predicted by Pretreatment LDAEP Slope (Calculated With N100 at the FZ Site)
大体时间：Administered at weeks 0, 2, 4, 6, 8, 10, 12, and 14
The QIDS-SR was used to measure the severity of depressive symptoms. The QIDS provides equivalent weightings (0-3) for each symptom item, gives clearly stated anchors that estimate the frequency and severity of symptoms, and includes all items required to diagnose a major depressive episode. The range for the total QIDS-SR severity score is 0-42, with higher scores indicating worse depression severity.
Administered at weeks 0, 2, 4, 6, 8, 10, 12, and 14
Quick Inventory of Depressive Symptomatology- Self Report (QIDS-SR) as Predicted by Pretreatment LDAEP Slope (Calculated With N100 at the CZ Site)
大体时间：Administered at weeks 0, 2, 4, 6, 8, 10, 12, and 14
The QIDS-SR was used to measure the severity of depressive symptoms. The QIDS provides equivalent weightings (0-3) for each symptom item, gives clearly stated anchors that estimate the frequency and severity of symptoms, and includes all items required to diagnose a major depressive episode. The range for the total QIDS-SR severity score is 0-42, with higher scores indicating worse depression severity.
Administered at weeks 0, 2, 4, 6, 8, 10, 12, and 14
Quick Inventory of Depressive Symptomatology- Self Report (QIDS-SR) as Predicted by Pretreatment LDAEP Slope (Calculated With N100 at the PZ Site)
大体时间：Administered at weeks 0, 2, 4, 6, 8, 10, 12, and 14
The QIDS-SR was used to measure the severity of depressive symptoms. The QIDS provides equivalent weightings (0-3) for each symptom item, gives clearly stated anchors that estimate the frequency and severity of symptoms, and includes all items required to diagnose a major depressive episode. The range for the total QIDS-SR severity score is 0-42, with higher scores indicating worse depression severity.
Administered at weeks 0, 2, 4, 6, 8, 10, 12, and 14
PTSD Checklist for DSM-5 (PCL-5) as Predicted by Pretreatment LDAEP Slope (Calculated With P200 at the FZ Site)
大体时间：Administered at weeks 0, 2, 4, 6, 8, 10, 12, and 14
The PCL-5 is a 20-item measure that assesses DSM-5 symptoms of PTSD, anchored to participants' worst traumatic event. The PCL-5 was administered bi-weekly at each psychiatrist check-in visit. Participants rated how much they experienced each symptom on a 5-point Likert-type scale (0 = "not at all" to 4 = "extremely") during the past week (total range=0-80). Higher scores indicate greater PTSD severity.
Administered at weeks 0, 2, 4, 6, 8, 10, 12, and 14
PTSD Checklist for DSM-5 (PCL-5) as Predicted by Pretreatment LDAEP Slope (Calculated With P200 at the CZ Site)
大体时间：Administered at weeks 0, 2, 4, 6, 8, 10, 12, and 14
The PCL-5 is a 20-item measure that assesses DSM-5 symptoms of PTSD, anchored to participants' worst traumatic event. The PCL-5 was administered bi-weekly at each psychiatrist check-in visit. Participants rated how much they experienced each symptom on a 5-point Likert-type scale (0 = "not at all" to 4 = "extremely") during the past week (total range=0-80). Higher scores indicate greater PTSD severity.
Administered at weeks 0, 2, 4, 6, 8, 10, 12, and 14
PTSD Checklist for DSM-5 (PCL-5) as Predicted by Pretreatment LDAEP Slope (Calculated With P200 at the PZ Site)
大体时间：Administered at weeks 0, 2, 4, 6, 8, 10, 12, and 14
The PCL-5 is a 20-item measure that assesses DSM-5 symptoms of PTSD, anchored to participants' worst traumatic event. The PCL-5 was administered bi-weekly at each psychiatrist check-in visit. Participants rated how much they experienced each symptom on a 5-point Likert-type scale (0 = "not at all" to 4 = "extremely") during the past week (total range=0-80). Higher scores indicate greater PTSD severity.
Administered at weeks 0, 2, 4, 6, 8, 10, 12, and 14
PTSD Checklist for DSM-5 (PCL-5) as Predicted by Pretreatment LDAEP Slope (Calculated With N100 at the FZ Site)
大体时间：Administered at weeks 0, 2, 4, 6, 8, 10, 12, and 14
The PCL-5 is a 20-item measure that assesses DSM-5 symptoms of PTSD, anchored to participants' worst traumatic event. The PCL-5 was administered bi-weekly at each psychiatrist check-in visit. Participants rated how much they experienced each symptom on a 5-point Likert-type scale (0 = "not at all" to 4 = "extremely") during the past week (total range=0-80). Higher scores indicate greater PTSD severity.
Administered at weeks 0, 2, 4, 6, 8, 10, 12, and 14
PTSD Checklist for DSM-5 (PCL-5) as Predicted by Pretreatment LDAEP Slope (Calculated With N100 at the CZ Site)
大体时间：Administered at weeks 0, 2, 4, 6, 8, 10, 12, and 14
The PCL-5 is a 20-item measure that assesses DSM-5 symptoms of PTSD, anchored to participants' worst traumatic event. The PCL-5 was administered bi-weekly at each psychiatrist check-in visit. Participants rated how much they experienced each symptom on a 5-point Likert-type scale (0 = "not at all" to 4 = "extremely") during the past week (total range=0-80). Higher scores indicate greater PTSD severity.
Administered at weeks 0, 2, 4, 6, 8, 10, 12, and 14
PTSD Checklist for DSM-5 (PCL-5) as Predicted by Pretreatment LDAEP Slope (Calculated With N100 at the PZ Site)
大体时间：Administered at weeks 0, 2, 4, 6, 8, 10, 12, and 14
The PCL-5 is a 20-item measure that assesses DSM-5 symptoms of PTSD, anchored to participants' worst traumatic event. The PCL-5 was administered bi-weekly at each psychiatrist check-in visit. Participants rated how much they experienced each symptom on a 5-point Likert-type scale (0 = "not at all" to 4 = "extremely") during the past week (total range=0-80). Higher scores indicate greater PTSD severity.
Administered at weeks 0, 2, 4, 6, 8, 10, 12, and 14

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

VA Office of Research and Development

合作者

Massachusetts General Hospital
Middlebury College
Ralph H. Johnson VA Medical Center

调查人员

  • 首席研究员：Suzanne Pineles, PhD、VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

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)

2019年9月11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31日

研究注册日期

首次提交

2019年11月27日

首先提交符合 QC 标准的

2019年11月27日

首次发布 (实际的)

2019年12月3日

研究记录更新

最后更新发布 (实际的)

2026年6月17日

上次提交的符合 QC 标准的更新

2026年5月26日

最后验证

2026年5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

  • MHBB-028-17F

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

研究完成后，将创建并共享去识别化、匿名化的数据集。

IPD 共享时间框架

数据将在提交最终报告后的一年内提供。

IPD 共享支持信息类型

  • 研究方案
  • 国际碳纤维联合会

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

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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