NCT01278498

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 444 (estimated)
• Sponsor: Asan Medical Center · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Depression

Interventions

Type	Name	Description
DRUG	Escitalopram	first week:5mg 2nd week\~12 week:10mg
DRUG	sugar pill	first week:5mg 2nd week\~12 weeks:10mg

Timeline

• Start date: 2011-01-01
• Primary completion: 2014-12-01
• Completion: 2015-12-01
• First posted: 2011-01-19
• Last updated: 2014-10-09

Locations

16 sites across 1 country: South Korea