The Role of Cytokine-Serotonin Interactions in Post-Stroke Depression
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 138
- 试验地点
- 10
- 主要终点
- Centre for Epidemiological Studies-Depression Scale (CES-D)
研究概览
简要总结
Depression is a common and often serious problem occurring in stroke patients. Inflammatory hormones, known as cytokines, are stimulated by an activated immune system and sometimes become active following a stroke. They may be responsible for altering levels of key neurotransmitters and their metabolites in the blood and brain of stroke patients. The investigators' objective is to examine whether increased cytokine activity following a stroke may be the cause of an increased presence or severity of depression or cognitive impairment among stroke patients, as a result of tryptophan depletion and/or kynurenine activation. They are recruiting patients within one month of their strokes and measuring levels of key markers in their blood. Patients are assessed for the presence of depressive and/or cognitive symptoms and treated with an antidepressant if needed. The investigators expect to show that cytokine activation is related to depression and/or cognitive impairment among stroke patients.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •Gender: male or female
- •Language: speaks and understands English
- •Clinical diagnosis of stroke according to World Health Organization MONICA Project and recent (< 3 months) cerebral infarctions
- •Written, informed consent
- •Depressed group only: diagnosis of a major depressive episode according to the depression module of the Structured Clinical Interview for the DSM-IV (SCID-IV)
排除标准
- •Subarachnoid hemorrhage
- •Intracranial hemorrhage
- •Significant acute medical illness including: drug overdose, severely disturbed liver, kidney or lung function, anemia, hypothyroidism, or uncontrolled diabetes
- •Significant acute neurologic illness including: impaired consciousness, Parkinson's disease, Huntington's chorea, progressive supranuclear paralysis, brain tumor, subdural hematoma, multiple sclerosis, hydrocephalus, Binswanger's disease, or severe aphasia
- •Presence of a premorbid Axis I psychiatric diagnosis (eg. schizophrenia, bipolar disorder)
- •Depressed group only: contraindications to receiving treatment with citalopram (including previous nonresponse) or serious risk of suicide
结局指标
主要结局
Centre for Epidemiological Studies-Depression Scale (CES-D)
时间窗: Baseline, 6 weeks, 12 weeks
Mini Mental State Examination (MMSE)
时间窗: Baseline, 6 weeks, 12 weeks
NINCDS-CSN Vascular Cognitive Impairment Battery
时间窗: Baseline, 6 weeks, 12 weeks
次要结局
- NIH Stroke Scale(Baseline, 6 weeks, 12 weeks)
- Modified Rankin Scale (mRS)(Baseline, 6 weeks, 12 weeks)