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

Depression Clinical Trial

— EMOTION  

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01278498
• Other study ID #: EMOTION
• Status: Unknown status
• Phase: Phase 4
• First received: January 18, 2011
• Last updated: October 8, 2014
• Start date: January 2011
• Est. completion date: December 2015

Study information

• Verified date: October 2014
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 444
• Est. completion date: December 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Stroke

Intervention

Drug:
• Escitalopram
first week:5mg 2nd week~12 week:10mg
• sugar pill
first week:5mg 2nd week~12 weeks:10mg

Locations

Country	Name	City	State
Korea, Republic of	Korea University Ansan Hospital	Ansan	Gyeonggi
Korea, Republic of	Hallym Univesity Sacred Heart Hospital	Anyang
Korea, Republic of	Dong-A University Hospital	Busan
Korea, Republic of	Kangwon National University Hospital	Chuncheon	Gangwon
Korea, Republic of	Daegu Fatima Hospital	Daegu	Gyeongsang
Korea, Republic of	Dongsan Medical Center	Daegu
Korea, Republic of	Chungnam National University Hospital	Daejeon
Korea, Republic of	Dongguk University International Hospital	Goyang	Kyoungki-do
Korea, Republic of	Hanyang University Guri Hospital	Guri	Gyeonggi-do
Korea, Republic of	Chosun University Hospital	Gwangju
Korea, Republic of	Kwandong University College of Medicine Myongji Hospital	Gyeonggi-do	Goyang
Korea, Republic of	Inha University Hospital	Inchon
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Konkuk Univ. Hospital	Seoul
Korea, Republic of	KyungHee University Medical Center	Seoul
Korea, Republic of	Severance Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Asan Medical Center	Dong-A ST Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence rate of depression	Occurrence rate of depression (Montgomery-Asberg Depression Scale score =16)	3 months
Secondary	Prevention of depression		3 months
Secondary	Prevention of emotional incontinence		3, 6 months
Secondary	Prevention of anger proneness		3, 6 months
Secondary	Recovery of neurologic dysfunction		3, 6 months
Secondary	Improvement of cognitive function		3, 6 months
Secondary	Improvement of quality of life		3, 6 months
Secondary	Improvement of caregiver burden		3, 6 months