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

• Status: Unknown status
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Asan Medical Center
• Collaborator: Dong-A ST Co., Ltd.
• Treatments: Citalopram; Dexetimide

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

• 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