Neurocognitive and Neuroimaging Biomarkers: Predicting Progression Towards Dementia in Patients With Treatment-resistant Late-life Depression (OPTIMUM-Neuro Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 506
- 试验地点
- 5
- 主要终点
- Persistent Depression Leading to Change in Cognition
研究概览
简要总结
The purpose of this study is to test whether treatment-resistant late life depression is associated with declines in memory and attention and brain structure and function.
详细描述
The purpose of this study is to test whether treatment-resistant late life depression is associated with declines in memory and attention and brain structure and function. The study will also test if changes in brain structure and function are associated with decreases in memory. In this study, investigators will conduct a series of assessments/tests, mainly brain imaging and assessments of participant's memory and attention, to better understand how depression is linked to memory and thinking in older persons. Investigators hope that their study will help the scientific community to understand why some people with depressive symptoms that are resistant to treatment in late-life experience declines in their memory and attention and whether effective treatment of such depression reduces that risk. Finally, investigators hope that this study will eventually lead to the development of better treatment options.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged 60 and older
- •Current Major Depressive Disorder (MDD)
- •Failure to respond adequately to two or more antidepressant treatment trials of recommended dose and length
- •Patient Health Questionnaire-9 (PHQ-9) score of 10 or higher
排除标准
- •Lifetime diagnosis of bipolar I or II disorder, schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, or current psychotic symptoms.
- •High risk for suicide and unable to be managed safely in the clinical trial
- •Non-correctable, clinically significant sensory impairment interfering with participation
- •Unstable medical illness, including delirium, uncontrolled diabetes mellitus, hypertension, hyperlipidemia, or cerebrovascular or cardiovascular risk factors that are not under medical management.
- •Moderate to severe substance or alcohol use disorder
- •Seizure disorder.
- •Parkinson's Disease
- •Individuals with any contraindications to MRI
结局指标
主要结局
Persistent Depression Leading to Change in Cognition
时间窗: Baseline, 6-months, 24-months
To test whether persistent (non-remitting) depression has the ability to change cognition and lead to greater cognitive decline, and greater degradation of neural circuitry
次要结局
- Change in Neural Circuity(Baseline, 6-months, 24-months)