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
Overview
- Phase
- Phase 4
- Intervention
- Escitalopram
- Conditions
- Depression
- Sponsor
- Asan Medical Center
- Enrollment
- 444
- Locations
- 16
- Primary Endpoint
- Occurrence rate of depression
- Last Updated
- 11 years ago
Overview
Brief Summary
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
Detailed Description
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.
Investigators
Jongsung Kim
professor, department of neurology
Asan Medical Center
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
escitalopram
prevention of poststroke depression in patients with acute stroke.
Intervention: Escitalopram
placebo
prevention of poststroke depression in patients with acute stroke.
Intervention: sugar pill
Outcomes
Primary Outcomes
Occurrence rate of depression
Time Frame: 3 months
Occurrence rate of depression (Montgomery-Asberg Depression Scale score ≥16)
Secondary Outcomes
- 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)