The Preventive Effect of Escitalopram on Depression and Related Emotional Disorders in Acute Stroke Patients "EMOTION"
Recruiting
Phase 4 Results N/AUpdate 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
|
View Trial Locations
Recruitment
- Enrollment: 444
- Gender: Both
- Minimum Age: 20 Years
- Accepts Healthy Volunteers: No
- 14 locations, 1 country
Principal Investigator
- Jong Sung Kim, MD, PhD
Department of Neurology, Asan Medical Center
