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临床试验/NCT01834677
NCT01834677
已完成
不适用

Translational Research Evaluating Neurocognitive Memory Processes

Duke University1 个研究点 分布在 1 个国家目标入组 76 人2013年4月

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Neurocognition
发起方
Duke University
入组人数
76
试验地点
1
主要终点
California Verbal Learning Test-II
状态
已完成
最后更新
10年前

概览

简要总结

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.

注册库
clinicaltrials.gov
开始日期
2013年4月
结束日期
2015年11月
最后更新
10年前
研究类型
Observational
性别
All

研究者

责任方
Sponsor

入排标准

入选标准

  • Depressed Individuals
  • Male and female subjects, age 18-85
  • DSM-IV-TR diagnosis of major depressive episode, unipolar, confirmed by the MINI-PLUS \[221\]
  • HRSD24 total score \> 10
  • MMSE total score \> 26
  • Graduated from high school
  • Competent to provide informed consent
  • Inclusion Criteria:Depressed Individuals Receiving ECT
  • Same as for Depressed Cohort Inclusion Criteria (see above)
  • Referred for ECT

排除标准

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

结局指标

主要结局

California Verbal Learning Test-II

时间窗: 1-Month Follow-up

The California Verbal Learning Test-II (CVLT-II) is a standard neuropsychological instrument that assesses verbal learning and memory.

研究点 (1)

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