Treatment Outcomes of Vascular Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 131
- 试验地点
- 4
- 主要终点
- Measured at Week 12: Montgomery-Asberg Depression Scale (MADRS)
研究概览
简要总结
This study will determine the relationship between brain lesion severity, treatment response, and frontal lobe brain function in people with late-life depression (LLD).
详细描述
Depression in older adults is a major public health problem and it often goes underdiagnosed and undertreated. A significant number of people with LLD, especially those with cerebrovascular risk factors, have subcortical grey matter and frontal deep white matter brain lesions. Some studies suggest that these lesions, or hyperintensities, may be associated with poor acute and long-term depression treatment response. Similarly, studies have shown that people with LLD frequently have functional deficits in the frontal lobe portion of their brains. This dysfunction has been shown to be associated with poor acute treatment response with a tricyclic antidepressant drug, as well as with a greater risk for depression relapse. The applicability of these findings to other classes of antidepressant medications, such as selective serotonin reuptake inhibitors (SSRIs), however, remains unknown. Additionally, more information is needed about the interaction between frontal brain lesions and executive function deficits in LLD. This study will determine the relationship between brain lesion severity, treatment response, and frontal lobe function in people with late-life depression who are being treated with the SSRI sertraline.
Participants in this open label study will first undergo neuropsychological testing to determine eligibility. All eligible participants will be treated with sertraline for 12 weeks. Dosages will begin at 25 mg per day, and will be increased to 50 mg per day after 4 days. Any other dosage modifications will depend on the participant's individual response to the medication. All participants will have an MRI scan at some point during the study. Assessments of symptoms and treatment response will occur at the study site biweekly until Week 8, and then again at Week 12.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- 否
入选标准
- •DSM-IV of major depressive disorder (MDD)
- •Score of greater than 20 on the MADRS (score of greater than 17 for atypical depression)
- •Score of greater than 20 on the Mini Mental State Examination (MMSE)
排除标准
- •Any condition that may make having an MRI medically inadvisable
- •Any severe or unstable medical conditions
- •Any known primary neurological disorders, including history of stroke
- •Any other simultaneous Axis I disorder
- •History of substance or alcohol abuse disorder within 6 months prior to study entry
- •Currently at risk for suicide
- •History of failed prior adequate trials of two antidepressants for the current depressive episode
- •History of failed prior adequate trial of sertraline
- •Current use of any other psychoactive medications (medication washout will be required)
结局指标
主要结局
Measured at Week 12: Montgomery-Asberg Depression Scale (MADRS)
次要结局
- Measured at Week 12: Hamilton Depression Rating Scale (Ham-D)
- Disability Assessment
- Clinical Global Impression (CGI)
- Quality of Life Assessment
