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

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ClinicalTrials.gov Identifier: NCT01278498
Recruitment Status : Unknown
Verified October 2014 by Jongsung Kim, Asan Medical Center.
Recruitment status was:  Active, not recruiting
First Posted : January 19, 2011
Last Update Posted : October 9, 2014
Sponsor:
Collaborator:
Dong-A ST Co., Ltd.
Information provided by (Responsible Party):
Jongsung Kim, Asan Medical Center

Tracking Information
First Submitted Date  ICMJE January 18, 2011
First Posted Date  ICMJE January 19, 2011
Last Update Posted Date October 9, 2014
Study Start Date  ICMJE January 2011
Estimated Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 18, 2011)
Occurrence rate of depression [ Time Frame: 3 months ]
Occurrence rate of depression (Montgomery-Asberg Depression Scale score ≥16)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01278498 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 18, 2011)
  • Prevention of depression [ Time Frame: 3 months ]
  • Prevention of emotional incontinence [ Time Frame: 3, 6 months ]
  • Prevention of anger proneness [ Time Frame: 3, 6 months ]
  • Recovery of neurologic dysfunction [ Time Frame: 3, 6 months ]
  • Improvement of cognitive function [ Time Frame: 3, 6 months ]
  • Improvement of quality of life [ Time Frame: 3, 6 months ]
  • Improvement of caregiver burden [ Time Frame: 3, 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Preventive Effect of Escitalopram on Depression and Related Emotional Disorders in Acute Stroke Patients
Official Title  ICMJE 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
Brief 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Depression
Intervention  ICMJE
  • Drug: Escitalopram
    first week:5mg 2nd week~12 week:10mg
    Other Name: lexacure
  • Drug: sugar pill
    first week:5mg 2nd week~12 weeks:10mg
    Other Name: Placebo
Study Arms  ICMJE
  • Experimental: escitalopram
    prevention of poststroke depression in patients with acute stroke.
    Intervention: Drug: Escitalopram
  • Placebo Comparator: placebo
    prevention of poststroke depression in patients with acute stroke.
    Intervention: Drug: sugar pill
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 18, 2011)
444
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2015
Estimated Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01278498
Other Study ID Numbers  ICMJE EMOTION
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jongsung Kim, Asan Medical Center
Study Sponsor  ICMJE Asan Medical Center
Collaborators  ICMJE Dong-A ST Co., Ltd.
Investigators  ICMJE
Principal Investigator: Jong Sung Kim, MD, PhD Department of Neurology, Asan Medical Center
PRS Account Asan Medical Center
Verification Date October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP