Antiglucocorticoid Therapy for Cognitive Impairment in Late-life Anxiety Disorders
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Drug Acceptability, as Measured by Number of Participants With Dose-limiting Side Effects
研究概览
简要总结
This study seeks to develop and test a novel, mechanistic treatment for mitigating cognitive impairment in older adults with anxiety disorders. Anxiety disorders are common, severe, and disabling in older adults. One particularly impairing aspect of late-life anxiety disorders is cognitive impairment: impairments in memory and executive function cause disability, impede treatment response to psychotherapy, may lead to dementia, and are not corrected by standard anti-anxiety treatments.
This pilot study will test the glucocorticoid antagonist, mifepristone, for cognitive impairment in late-life anxiety disorders. Mifepristone blocks the effects of elevated cortisol levels on glucocorticoid receptors in the brain; it has been studied preliminarily in various neuropsychiatric disorders, such as psychotic depression and bipolar disorder, with well-documented safety and tolerability.
详细描述
Currently, no treatment exists to address cognitive impairment in late-life anxiety disorders. In this study, fifteen patients aged 60+ with an anxiety disorder (current or in partial remission) and subjective and/or objective evidence of cognitive impairment will receive treatment with mifepristone. At the baseline visit participants will be randomized to receive either mifepristone 300mg or a placebo daily for 7 days. Participants will be reassessed after 7 days (week 1 visit) of receiving study medication (mifepristone or placebo). At that time all participants will be provided mifepristone 300mg daily for the remaining 3 weeks of study treatment. The primary outcome measure will be neurocognition, as assessed by a battery of neuropsychological measures focusing on immediate and delayed memory and executive function (administered at baseline, week 1, week 4, and week 12). Saliva samples for cortisol measurement will be collected immediately following the baseline visit and week 4 visit. Secondary outcomes will be self-reported anxiety and depressive symptoms.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 65 and older
- •Non-demented by clinical evaluation
- •Current or partially remitted generalized anxiety disorder or panic disorder
- •Currently taking antidepressant treatment with stable dose for at least 8 weeks
- •Memory impairment
排除标准
- •Mild to severe dementia
- •Current alcohol or substance abuse
- •Current or lifetime psychotic symptoms, bipolar disorder, or eating disorder
- •Untreated endocrinologic disease
- •Lifetime Cushing's or Addison's disease
- •Current cancer
- •History of metastatic cancer
- •Current use of systemic corticosteroids
研究组 & 干预措施
mifepristone
1 week mifepristone or placebo (followed by 3 weeks open label mifepristone)
干预措施: Mifepristone (Drug)
结局指标
主要结局
Drug Acceptability, as Measured by Number of Participants With Dose-limiting Side Effects
时间窗: Baseline, Week 2, Week 4
number of participants with dose-limiting side effects
Number of Participants With Self-reported Side Effects
时间窗: 4 weeks
Cognitive Changes Over Time, as Measured by Between Group and Within-subjects Comparison of Neuropsychological Measures.
时间窗: Baseline, Week 4, Week 12
Memory composite z-score: The two memory measures were a 16-word list recall similar to the Rey auditory verbal learning test, which has been used by the Washington University Alzheimer's Disease Research Center; and two paragraphs from a set of paragraph recall tests validated as sensitive to effects of stress-level glucocorticoids. For each memory variable, a z score was computed for each participant, where z score = (participant score mean)/standard deviation. Then a single composite memory variable was created by summing up these z scores. Summed Z-scores range from -6 to 6, with scores above 0 being higher than the mean.
次要结局
- Anxiety Symptoms(baseline, week 4, week 12)