Neurophysiologic Monitoring of Antidepressant Treatment
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 24
- 主要终点
- Change in Hamilton Rating Scale For Depression Score
研究概览
简要总结
The overall goal of this proposal is to study quantitative electroencephalography (QEEG ) as a method for the detection of antidepressant treatment response. The investigators have developed a QEEG algorithm called "cordance" that appears to provide much the same information about brain function as PET or SPECT scanning, and has shown patterns of brain function that appear to be indicative of depression. Of greatest interest is that these patterns appear to normalize in response to antidepressant treatment.
详细描述
Background and Significance/Preliminary Studies:
A. Cordance. There is considerable evidence indicating that abnormal slow-wave activity in the EEG is caused by partial cortical deafferentation. Despite this fact, no clinically relevant measure of deafferentation has been available. The investigators sought to develop such a measure by examining young and old subjects with white-matter lesions that presumably undercut the cerebral cortex, as well as subjects with several different types of brain disease who had undergone SPECT scanning. The investigators discovered an indicator termed discordance, that is characteristic of cortex undercut by white-matter lesions, or that is hypoperfused for any reason. The investigators also discovered an indicator the investigators termed concordance , which is characteristic of cortex that has normal perfusion.
This overall technique for the non-invasive assessment of afferent function, cerebral perfusion, and metabolism the investigators call cordance mapping, which is the subject of a United States patent. A detailed explanation of the formulae used to calculate cordance is provided in the manuscripts referenced above. The first of these two manuscripts contains illustrative examples where discordance was useful in detection of white-matter lesions or degenerative disease. The second manuscript shows a quantitative analysis of cordance and HMPAO-SPECT data from 27 patients with a variety of conditions, and demonstrates that cordance is superior to conventional EEG measures in its correlations with relative perfusion. Like SPECT, cordance measurements vary according to the patients' state, but has high test-retest reliability for detecting brain lesions.
B. Differential diagnosis of depression. One promising application of cordance is to the differential diagnosis of psychiatric illness. A "normal" cordance pattern is one of posterior dominant concordance with cordance values near zero in the frontal regions. The investigators have reported a "classic" cordance pattern for subjects with Alzheimer's disease (DAT), in which there is parietal discordance (in the beta or theta bands) in conjunction with alpha concordance that has shifted from the occipital to the central head regions. This finding is consistent with the pattern seen commonly on PET and SPECT, in which there is parietal hypoperfusion or hypometabolism with preserved metabolism over the central head regions (the motor strip), which is known to be less affected by Alzheimer's changes.
In evaluating treatment results, the investigators will need to determine what effect medication status has upon QEEG measures. Although results thus far suggest that there is little significant effect , the investigators will carefully examine the effects of antidepressant and antianxiety medications further
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All subjects will meet DSM-IV criteria for major depression based upon the Structured Clinical Interview for DSM-IV - Patient Version (SCID-P) (First et al., 1994). All research personnel have undergone SCID-P training, and soon will extend this training to the DSM-IV version.
- •Subjects also will have a score on the 17-item Hamilton Depression Rating Scale of > 18 (with item #1 > 2).
- •All subjects will be under the care of a clinician not affiliated with the study at the time of entry into the study, and through the course of the study.
排除标准
- •Subjects will have no serious medical illness.
- •We will exclude patients also meeting criteria for the following groups of axis I diagnoses: delirium or dementia, substance-related disorders, schizophrenia or other psychotic disorders, or eating disorders.
- •In addition, patients meeting criteria for cluster A or B axis II diagnoses will be excluded.
- •Subjects with a history of current or past active suicidal ideation, or suicide attempts will be excluded, as will patients who previously have failed to respond to an adequate clinical trial of fluoxetine, or have failed to tolerate the medication.
- •Subjects who have had suboptimal trials, however, may still be considered for the study.
研究组 & 干预措施
fluoxetine
干预措施: fluoxetine (Drug)
placebo
干预措施: fluoxetine (Drug)
结局指标
主要结局
Change in Hamilton Rating Scale For Depression Score
时间窗: baseline, end of placebo-lead-in; and 48 hours, 1 week, 2 weeks, 4 weeks, and 8 weeks after randomized treatment
We will determine which subjects demonstrate improvement on the primary outcome measure (Ham-D) obtained the day of the EEG, and enter these as categorical variables (improved/not improved).
次要结局
未报告次要终点