Preventative Treatment of Depression in Survivors of Aneurysmal Subarachnoid Hemorrhage
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Depression
研究概览
简要总结
A double-blinded placebo-controlled randomized trial to evaluate the effect of preventative treatment of depression in survivors of aneurysmal subarachnoid hemorrhage (aSAH), a type of stroke.
详细描述
Patients who suffered aneurysmal subarachnoid hemorrhage will be randomly assigned either an oral antidepressant or placebo and evaluated for the preventative treatment of depression and health-related quality-of-life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 18-85 years of age aged 18 years and older will be included.
- •Patients admitted for subarachnoid hemorrhage from a ruptured cerebral aneurysm will be included.
- •Only patients who provide informed consent will be included.
排除标准
- •Non-English speaking patients will be excluded.
- •Patients currently receiving therapy for depression or related mental health diagnoses before admission will be excluded.
- •Patients with medical contraindications to fluoxetine therapy will be excluded.
- •Pregnant patients or patients considering pregnancy during the trial period at the time of consent will be excluded.
- •Patients with active psychosis will be excluded.
- •Patients who are incarcerated or in police custody will be excluded.
- •Patients with a comorbidity or cognitive impairment (as determined by a recruiter-administered Montreal Cognitive Assessment; Patients scoring >26 are considered of appropriate cognitive function for consent) that precludes informed consent and participation in the research interviews will be excluded.
研究组 & 干预措施
Treatment
Patients randomized to the fluoxetine treatment group will be initially prescribed fluoxetine 20mg/day for a period of one year.
干预措施: Fluoxetine (Drug)
Placebo
Patients randomized to the placebo group will be initially prescribed placebo 20mg/day for a period of one year.
干预措施: Placebo (Drug)
结局指标
主要结局
Depression
时间窗: 1 year
Depression will be assessed using the Patient Health Questionnaire (PHQ-9). The PHQ-9 is a 9 item questionnaire to treat and diagnose depression. The minimum score is 1, and the maximum score is 27. 1-4: minimal depression 5-9: mild depression 10-14: moderate depression 15-19: moderately severe depression 20-27: severe depression
次要结局
- Anxiety(1 year)
- Fatigue(1 year)
- Healthcare Utilization(1 year)
- Social Support(1 year)
- Sleep Disturbance(1 year)
- Function(1 year)
研究者
Michael Robert Levitt, MD
Assistant Professor, School of Medicine, Neurological Surgery
University of Washington