A Multicenter, Double Blind Trial to Compare the Efficacy and Safety of Escitalopram With Placebo in Patients With Acute Stroke for the Prevention of Poststroke Depression and Related Symptoms (Emotional Incontinence, Anger Proneness), and for Improvement of Neurologic, Cognitive Function and Quality of Life
试验速览
- 阶段
- 4 期
- 入组人数
- 444
- 试验地点
- 16
- 主要终点
- Occurrence rate of depression
研究概览
简要总结
Through this study, the investigators are to demonstrate the superiority of Escitalopram over placebo for the prevention of poststroke depression in patients with acute stroke
The primary hypothesis of this study is;
This study will prove the superiority of Escitalopram on the prevention of poststroke depression in patients with acute stroke against placebo
详细描述
This study is to randomize stroke patients either to the SSRI, Lexacure tablet or placebo and to investigate whether Lexacure is effective in preventing depression and related symptoms at 3 months after the drug administration.
Patients with acute stroke (within 21 days after onset) will be enrolled and take the study drug 5mg during the first week and then 10mg (from the 2nd week) until 12 weeks.
The first visit should be performed at 4 weeks after drug administration. Drug safety, depression and related symptoms will be evaluated and the following 12-week visit will be performed. In the 13th week after the drug administration, the study drug will be reduced to 10mg every other day for one week, and the schedule of drug administration will be completed.
At the 14th week, all subjects will be instructed not to take the study drug for assessing maintenance effect. At the 24th week, subjects will have follow-up visits to assess poststroke depression and related symptoms.
If a subject discontinues the study before termination for severe depression, aggressive intervention will be initiated at the 4th week, and the 12-week visit will be performed unless the subject disagrees. If investigators judge the patients have severe depression at the 12-week visit, they should be treated. All the patients who need to treat depression will be followed until 12th week.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults older than 20 years
- •Patients with acute stroke (ischemic stroke or cerebral hemorrhage) confirmed by neuroimaging within 21 days after stroke onset
- •Patients with hemorrhagic transformation of infarcted tissue will not be included, but if investigators judge the risk of bleeding is small (i.e., reduced amount of blood in follow-up neuroimaging) those patients can be enrolled.
- •Patients with MRS ≥ 2 on screening
- •Patients without definite history of depression
- •Patients who fulfill the following criteria in the K-MADRS test:
- •The combined score of the 9th question (pessimistic thoughts) and the 10th question (suicidal idea) ≤ 7 The score of the 10th question < 6
- •Patients without serious communication problem
- •Patients who agree to participate in this trial
排除标准
- •Patients with MRS 0 or 1 on screening
- •Patients who have definite history of depression or have taken antidepressants
- •Patients who have been diagnosed as having bipolar disorder or other psychiatric disorders
- •Patients with severe dementia or aphasia. However, those who have motor aphasia but are still communicable can be enrolled
- •Patients who have taken migraine medication on screening or those who are expected to take migraine medication frequently due to severe migraine
- •Patients who have strong suicidal idea on screening test or those who express their wish to be treated for depression
- •Patients who are considered to be treated for depression by charged physicians
- •Patients who need SSRI medication for other reasons
- •Patients who have taken antiepileptic drugs on screening
- •Patients who have a history of traumatic brain injury, brain tumor, or other brain disease (except stroke) within 30 days prior to screening
- •Patients with uncommon causes of stroke (e.g. subarachnoid hemorrhage, venous thrombosis, arteriovenous malformation, or Moyamoya disease)
- •Patients with bleeding diathesis, hemophilia, or thrombocytopenia
- •Patients with severe concomitant illness (e.g. liver disease, renal disease, malignancy)
- •Patients with abnormal blood tests Abnormal LFT (ALT > 200 or AST > 200) Anemia (Hb < 8 mg/dl) or thrombocytopenia (<100,000/mm3) Renal insufficiency (Cr > 3.0 mg/dl) or renal failure requiring dialysis Patients with severe heart failure (NYHA class III or IV) NYHA classification for heart failure Class I : patients with no limitation of activities; they suffer no symptoms from Ordinary activities Class II : patients with slight, mild limitation of activity; they are comfortable with rest or with mild exertion Class III : patients with marked limitation of activity; they are comfortable only at rest Class IV : patients who should be at complete rest, confined to bed or chair; any activity brings on
- •Pregnant or lactating patients
- •Patients who are participating in another clinical trial, but those who are participating in the observational study can be enrolled
研究组 & 干预措施
escitalopram
prevention of poststroke depression in patients with acute stroke.
干预措施: Escitalopram (Drug)
placebo
prevention of poststroke depression in patients with acute stroke.
干预措施: sugar pill (Drug)
结局指标
主要结局
Occurrence rate of depression
时间窗: 3 months
Occurrence rate of depression (Montgomery-Asberg Depression Scale score ≥16)
次要结局
- Prevention of depression(3 months)
- Improvement of cognitive function(3, 6 months)
- Improvement of quality of life(3, 6 months)
- Improvement of caregiver burden(3, 6 months)
- Prevention of emotional incontinence(3, 6 months)
- Prevention of anger proneness(3, 6 months)
- Recovery of neurologic dysfunction(3, 6 months)
研究者
Jongsung Kim
professor, department of neurology
Asan Medical Center