Aging White Matter Changes, Executive Dysfunction and Depression
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 116
- 主要终点
- WHODAS-II Disability Scale
研究概览
简要总结
The purpose of this study is to look at the relationship between age related structural brain changes and changes in depressive symptoms,disability and several aspects of cognitive functioning following treatment with escitalopram.
详细描述
Age-related brain changes have been associated with development of late-life depression. Prominent among aging-related changes is decline in white matter disproportionately affecting frontal structures.Based on previous findings, we conceptualized treatment resistance, disability, and executive dysfunction as clinical phenomena contributed, at least in part, by compromised integrity of frontal neural systems. The study focuses on frontal white matter abnormalities in geriatric depression and their relationship to treatment response, disability,and executive dysfunction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: Two strata: 60-74 years (n=60) subjects and 75-84 years (n=60).
- •Diagnosis: Major depression, unipolar (by DSM-IV criteria); or, for control subjects, no diagnosis of major depression, no history of depression or other psychiatric conditions.
- •Severity of depression: A 24-Item HDRS above 19; Level of Executive Dysfunction: Two strata within each age stratum: Stroop Color-Word scores below and above 24 (1 SD below the median of our normal elderly sample).
排除标准
- •Psychotic depression by DSM-IV, i.e., presence of delusions with a score higher than 2 (questionable delusion) rated by the Scale for Assessment of Positive Symptoms (SAPS; 51).
- •High suicide risk, i.e. intent or plan to attempt suicide in near future.
- •Presence of any Axis I psychiatric disorder or substance abuse other than unipolar major depression.
- •Axis II diagnosis of antisocial personality (by SCID-P and DSM-IV).
- •History of psychiatric disorders other than unipolar major depression or generalized anxiety disorder (bipolar disorder, hypomania, are exclusion criteria).
- •Cognition: MMSE scores below 24 or diagnosis of dementia by DSM-IV.
- •Acute or severe medical illness, i.e., delirium, metastatic cancer, decompensated cardiac, liver or kidney failure, major surgery, stroke or myocardial infarction during the three months prior to entry; or drugs known to cause depression, e.g., reserpine, alpha-methyl-dopa, steroids.
- •Failure to respond to an adequate trial of escitalopram (10 mg/day or more for 6 weeks or longer) during the current or previous depressive episodes.
- •Current involvement in psychotherapy.
- •History of hypersensitivity to escitalopram or need to receive drugs that may interact with escitalopram.
- •Inability to perform any of the ADLs (MAI: ADL subscale) even with assistance, e.g. walking with a cane is not an exclusion criterion.
- •Inability to speak English.
- •Residence outside a 45-minute drive from Cornell's clinical facilities.
- •Patients taking MAOI's and Fluoxetine will be excluded.
研究组 & 干预措施
Escitalopram
12-week open label with 2 week placebo period (14 weeks total)
干预措施: Escitalopram (Drug)
结局指标
主要结局
WHODAS-II Disability Scale
时间窗: 14 weeks (12th week of treatment)
A disability rating scale published by the World Health Organization, the WHODAS II total scores can range from 0-100. Higher scores indicate greater severity of disability. Total scores are reported with no subscales.
Hamilton Depression Rating Scale.
时间窗: 14 weeks (12th week of treatment)
A published and widely-used scale for rating depression severity, the Hamilton Depression Rating Scale 24 item total scores range from 0-76. Higher scores indicate greater severity of depression. Total scores are reported with no subscales.
Stroop Color-Word Test
时间窗: 14 weeks (12th week of treatment)
A published and widely used executive dysfunction test, the Stroop Color-Word total scores can range from 0-100. Higher scores indicate better memory functioning (no cognitive impairment). Total scores are reported with no subscales.
次要结局
未报告次要终点