The Preventive Effect of Escitalopram on Depression and Related Emotional Disorders in Acute Stroke Patients "EMOTION"

Recruiting

Phase 4 Results N/A

Update History

27 Jan '12
A location was updated in Goyang.
New
The overall status was updated to "Recruiting" at Dongguk University International Hospital.
A location was updated in Anyang.
New
The overall status was updated to "Recruiting" at Hallym Univesity Sacred Heart Hospital.
A location was updated in Busan.
New
The overall status was updated to "Recruiting" at Dong-A University Hospital.
A location was updated in Daegu.
New
The overall status was updated to "Recruiting" at Dongsan Medical Center.
A location was updated in GwangJu.
New
The overall status was updated to "Recruiting" at Chosun University Hospital.
A location was updated in Inchon.
New
The overall status was updated to "Recruiting" at Inha University Hospital.
A location was updated in Seoul.
New
The overall status was updated to "Recruiting" at Severance Hospital.
A location was updated in Seoul.
New
The overall status was updated to "Recruiting" at KyungHee University Medical Center.
6 Oct '11
The eligibility criteria were updated.
New
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 - 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
Old
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 - 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