The Preventive Effect of Escitalopram on Depression and Related Emotional Disorders in Acute Stroke Patients
NCT ID: NCT01278498
Last Updated: 2014-10-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
444 participants
INTERVENTIONAL
2011-01-31
2015-12-31
Brief Summary
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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
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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escitalopram
prevention of poststroke depression in patients with acute stroke.
Escitalopram
first week:5mg 2nd week\~12 week:10mg
placebo
prevention of poststroke depression in patients with acute stroke.
sugar pill
first week:5mg 2nd week\~12 weeks:10mg
Interventions
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Escitalopram
first week:5mg 2nd week\~12 week:10mg
sugar pill
first week:5mg 2nd week\~12 weeks:10mg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
20 Years
ALL
No
Sponsors
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Dong-A ST Co., Ltd.
INDUSTRY
Asan Medical Center
OTHER
Responsible Party
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Jongsung Kim
professor, department of neurology
Principal Investigators
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Jong Sung Kim, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Neurology, Asan Medical Center
Locations
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Kangwon National University Hospital
Chuncheon, Gangwon-do, South Korea
Kwandong University College of Medicine Myongji Hospital
Gyeonggi-do, Goyang, South Korea
Korea University Ansan Hospital
Ansan, Gyeonggi-do, South Korea
Hanyang University Guri Hospital
Guri-si, Gyeonggi-do, South Korea
Daegu Fatima Hospital
Daegu, Gyeongsang, South Korea
Dongguk University International Hospital
Goyang, Kyoungki-do, South Korea
Hallym Univesity Sacred Heart Hospital
Anyang, , South Korea
Dong-A University Hospital
Busan, , South Korea
Dongsan Medical Center
Daegu, , South Korea
Chungnam National University Hospital
Daejeon, , South Korea
Chosun University Hospital
Gwangju, , South Korea
Inha University Hospital
Inchon, , South Korea
Severance Hospital
Seoul, , South Korea
KyungHee University Medical Center
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Konkuk Univ. Hospital
Seoul, , South Korea
Countries
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References
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Lee EJ, Kim JS, Chang DI, Park JH, Ahn SH, Cha JK, Heo JH, Sohn SI, Lee BC, Kim DE, Kim HY, Kim S, Kwon DY, Kim J, Seo WK, Lee J, Park SW, Koh SH, Kim JY, Choi-Kwon S, Kim MS, Lee JS. Post-Stroke Depressive Symptoms: Varying Responses to Escitalopram by Individual Symptoms and Lesion Location. J Geriatr Psychiatry Neurol. 2021 Nov;34(6):565-573. doi: 10.1177/0891988720957108. Epub 2020 Sep 10.
Lee EJ, Kim JS, Chang DI, Park JH, Ahn SH, Cha JK, Heo JH, Sohn SI, Lee BC, Kim DE, Kim HY, Kim S, Kwon DY, Kim J, Seo WK, Lee J, Park SW, Koh SH, Kim JY, Choi-Kwon S. Depressive Symptoms in Stroke Patients: Are There Sex Differences? Cerebrovasc Dis. 2020;49(1):19-25. doi: 10.1159/000506116. Epub 2020 Feb 5.
Lee EJ, Kim JS, Chang DI, Park JH, Ahn SH, Cha JK, Heo JH, Sohn SI, Lee BC, Kim DE, Kim HY, Kim S, Kwon DY, Kim J, Seo WK, Lee J, Park SW, Koh SH, Kim JY, Choi-Kwon S, Kim MS, Lee JS; EMOTION Investigators. Differences in Therapeutic Responses and Factors Affecting Post-Stroke Depression at a Later Stage According to Baseline Depression. J Stroke. 2018 May;20(2):258-267. doi: 10.5853/jos.2017.02712. Epub 2018 May 31.
Lee EJ, Oh MS, Kim JS, Chang DI, Park JH, Cha JK, Heo JH, Sohn SI, Kim DE, Kim HY, Kim J, Seo WK, Lee J, Park SW, Kim YJ, Lee BC; EMOTION investigators. Serotonin transporter gene polymorphisms may be associated with poststroke neurological recovery after escitalopram use. J Neurol Neurosurg Psychiatry. 2018 Mar;89(3):271-276. doi: 10.1136/jnnp-2017-316882. Epub 2017 Oct 13.
Kim JS, Lee EJ, Chang DI, Park JH, Ahn SH, Cha JK, Heo JH, Sohn SI, Lee BC, Kim DE, Kim HY, Kim S, Kwon DY, Kim J, Seo WK, Lee J, Park SW, Koh SH, Kim JY, Choi-Kwon S; EMOTION investigators. Efficacy of early administration of escitalopram on depressive and emotional symptoms and neurological dysfunction after stroke: a multicentre, double-blind, randomised, placebo-controlled study. Lancet Psychiatry. 2017 Jan;4(1):33-41. doi: 10.1016/S2215-0366(16)30417-5.
Other Identifiers
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EMOTION
Identifier Type: -
Identifier Source: org_study_id
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