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Translational Research Evaluating Neurocognitive Memory Processes (TREC-MP)

2015年12月1日 更新者：Duke University

The purpose of this study is to evaluate the psychometric properties and utility of new, computerized, neurocognitive measures in humans with depression, and humans with depression undergoing electroconvulsive therapy (ECT). The benefits of the study outweigh the risk as there is the possibility of developing better computerized neurocognitive measures, and the risks are limited to no more than minimal test related fatigue and psychological stress.

Depressed humans, depressed human participants undergoing ECT, and humans diagnosed with Parkinson's disease (age 18-85) will be invited to participate in this study. After providing informed consent participants will undergo a clinical psychiatric evaluation to confirm the inclusion/exclusion criteria. After the clinical psychiatric evaluation, participants will complete common and new neurocognitive measures. There will be a total of two testing visits (baseline, 1-month follow-up). The anticipated duration of the participant's involvement is no more than 2 study visits that can take place over a 4-day period (i.e., the clinical evaluation can occur on day 1 and the neuropsychological measures can be administered on day 2 of each study visit) equating to approximately 6-hours (3-hours each day) per study visit.

研究概览

地位

完全的

条件

研究类型

观察性的

注册 (实际的)

76

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
    • North Carolina
      • Durham、North Carolina、美国、27710
        • Duke Universtiy Medical Center

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 85年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Subjects are able to contact the study team. The depressed ECT cohort will be referred to study team.

描述

Inclusion Criteria:Depressed Individuals

  1. Male and female subjects, age 18-85
  2. DSM-IV-TR diagnosis of major depressive episode, unipolar, confirmed by the MINI-PLUS [221]
  3. HRSD24 total score > 10
  4. MMSE total score > 26
  5. Graduated from high school
  6. Competent to provide informed consent

Inclusion Criteria:Depressed Individuals Receiving ECT

  1. Same as for Depressed Cohort Inclusion Criteria (see above)
  2. Referred for ECT
  3. Subject competent to provide informed consent

Inclusion Criteria:Individuals Diagnosed with PD

  1. Male and female subjects, age 18-85
  2. Diagnosed with PD
  3. MMSE total score > 20
  4. Graduate high school
  5. Subject competent to provide informed consent

Exclusion Criteria:Depressed Individuals/Depressed Individuals Receiving ECT

  1. Lifetime history of bipolar disorder, schizophrenia, schizoaffective disorder, or mental retardation
  2. Current neurostimulation treatment (e.g., ECT, MST, rTMS, vagus nerve stimulation, deep brain stimulation)
  3. Current alcohol abuse or dependence within past 12 months
  4. Current substance abuse or dependence within past 12 months
  5. Lifetime mental retardation
  6. History of central nervous system (CNS) disease
  7. Current diagnosis of dementia or delirium
  8. Current visual, auditory, or motor impairment that compromises ability to take tests
  9. Unable to read or comprehend English

Exclusion Criteria:Individuals Diagnosed with PD

  1. Lifetime history of bipolar disorder, schizophrenia, schizoaffective disorder, or mental retardation
  2. Current neurostimulation treatment (e.g., ECT, MST, rTMS, vagus nerve stimulation, deep brain stimulation)
  3. Current alcohol abuse or dependence within past 12 months
  4. Current substance abuse or dependence within past 12 months
  5. Lifetime mental retardation
  6. History of central nervous system (CNS) disease other than Parkinson's Disease
  7. Current diagnosis of dementia or delirium
  8. Current visual, auditory, or motor impairment that compromises ability to take tests
  9. Unable to read or comprehend English

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

队列和干预

团体/队列
Healthy Human
Depressed Human
Depressed Human, Undergoing Electroconvulsive Therapy
Electroconvulsive Therapy is being received as standard of care, not as a study intervention.
Human Diagnosed with Parkinson's Disease

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
California Verbal Learning Test-II
大体时间：Baseline
The California Verbal Learning Test-II (CVLT-II) is a standard neuropsychological instrument that assesses verbal learning and memory.
Baseline
California Verbal Learning Test-II
大体时间：1-Month Follow-up
The California Verbal Learning Test-II (CVLT-II) is a standard neuropsychological instrument that assesses verbal learning and memory.
1-Month Follow-up

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

Duke University

合作者

National Institute of Mental Health (NIMH)

调查人员

  • 首席研究员：Shawn McClintock, PhD、Duke University

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

2013年4月1日

初级完成 (实际的)

2015年11月1日

研究完成 (实际的)

2015年11月1日

研究注册日期

首次提交

2013年4月16日

首先提交符合 QC 标准的

2013年4月16日

首次发布 (估计)

2013年4月18日

研究记录更新

最后更新发布 (估计)

2015年12月3日

上次提交的符合 QC 标准的更新

2015年12月1日

最后验证

2015年12月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • Pro00039288
  • 5K23MH087739-03 (美国 NIH 拨款/合同)

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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条件

罕见疾病

药物干预

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3
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