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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Asan Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Dong-A Pharmaceutical Co., Ltd.
Information provided by:
Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01278498
First received: January 18, 2011
Last updated: June 14, 2012
Last verified: January 2011
  Purpose

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


Condition Intervention Phase
Depression
Drug: Escitalopram
Drug: sugar pill
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • Occurrence rate of depression [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Occurrence rate of depression (Montgomery-Asberg Depression Scale score ≥16)


Secondary Outcome Measures:
  • Prevention of depression [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Prevention of emotional incontinence [ Time Frame: 3, 6 months ] [ Designated as safety issue: No ]
  • Prevention of anger proneness [ Time Frame: 3, 6 months ] [ Designated as safety issue: No ]
  • Recovery of neurologic dysfunction [ Time Frame: 3, 6 months ] [ Designated as safety issue: No ]
  • Improvement of cognitive function [ Time Frame: 3, 6 months ] [ Designated as safety issue: No ]
  • Improvement of quality of life [ Time Frame: 3, 6 months ] [ Designated as safety issue: No ]
  • Improvement of caregiver burden [ Time Frame: 3, 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 444
Study Start Date: January 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: escitalopram
prevention of poststroke depression in patients with acute stroke.
Drug: Escitalopram
first week:5mg 2nd week~12 week:10mg
Other Name: lexacure
Placebo Comparator: placebo
prevention of poststroke depression in patients with acute stroke.
Drug: sugar pill
first week:5mg 2nd week~12 weeks:10mg
Other Name: 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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01278498

Contacts
Contact: Jong Sung Kim, MD,PhD 82-2-3010-3442 jongskim@amc.seoul.kr

Locations
Korea, Republic of
Kangwon National University Hospital Not yet recruiting
Chuncheon, Gangwon, Korea, Republic of, 200-722
Contact: Sung Hun Kim         
Kwandong University College of Medicine Myongji Hospital Recruiting
Gyeonggi-do, Goyang, Korea, Republic of, 412-270
Contact: Jong-Ho Park       neurocraft@kd.ac.kr   
Hanyang University Guri Hospital Recruiting
Guri, Gyeonggi-do, Korea, Republic of, 471-701
Contact: Sung Ho Koh    82-32-560-2267    ksh213@hanyang.ac.kr   
Korea University Ansan Hospital Recruiting
Ansan, Gyeonggi, Korea, Republic of, 425-707
Contact: Moon Ho Park         
Principal Investigator: Moon Ho Park         
Daegu Fatima Hospital Not yet recruiting
Daegu, Gyeongsang, Korea, Republic of, 701-600
Contact: Sang Won Park         
Principal Investigator: SangWon Park         
Dongguk University International Hospital Recruiting
Goyang, Kyoungki-do, Korea, Republic of, 410-773
Contact: Dong Eog Kim, MD    82-31-961-7207    kdongeog@duih.org   
Principal Investigator: Dong Eog Kim, MD         
Sub-Investigator: Sang-Wok Jeong, MD         
Hallym Univesity Sacred Heart Hospital Recruiting
Anyang, Korea, Republic of, 430-070
Contact: Byung-Chul Lee, MD    82-31-380-3741    ssbrain@hallym.ac.kr   
Principal Investigator: Byung-Chul Lee, MD         
Sub-Investigator: Mi Sun Oh, MD         
Dong-A University Hospital Recruiting
Busan, Korea, Republic of, 602-715
Contact: Jae Kwan Cha, MD    82-10-5229-6525    nrcjk@unitel.co.kr   
Principal Investigator: Jae Kwan Cha, MD         
Dongsan Medical Center Recruiting
Daegu, Korea, Republic of, 700-712
Contact: Kyung-Hee Cho, MD    82-53-250-7074    khcho@dsmc.or.kr   
Principal Investigator: Kyung-Hee Cho, MD         
Chungnam National University Hospital Recruiting
Daejeon, Korea, Republic of, 301-721
Contact: Jei Kim, MD    82-42-280-7805    jekim@cnu.ac.kr   
Principal Investigator: Jei Kim, MD         
Sub-Investigator: Hee-Jung Song, MD         
Chosun University Hospital Recruiting
Gwangju, Korea, Republic of, 501-717
Contact: Seong Hwan Ahn, MD    82-62-220-3663    shahn@chosun.ac.kr   
Principal Investigator: Seong Hwan Ahn, MD         
Sub-Investigator: Doung Uk Kim, MD         
Inha University Hospital Recruiting
Inchon, Korea, Republic of, 400-103
Contact: Joung Ho Rha, MD    82-32-890-3418    jhrha@inha.ac.kr   
Principal Investigator: Joung Ho Rha, MD         
Sub-Investigator: Hee Kwon Park, MD         
Severance Hospital Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Ji Hoe Heo, MD    82-2-2228-1605    jhheo@yuhs.ac   
Principal Investigator: Ji Hoe Heo, MD         
Sub-Investigator: Hyo Suk Nam, MD         
Sub-Investigator: Dong Hyun Lee, MD         
KyungHee University Medical Center Recruiting
Seoul, Korea, Republic of, 130-702
Contact: Dae-Il Chang, MD    82-2-958-8497    dichang@khmc.or.kr   
Principal Investigator: Dae-Il Chang, MD         
Sub-Investigator: Sung Hyuk Heo, MD         
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 138-736
Contact: JongSung Kim, MD    82-2-3010-3442    jongskim@gmail.com   
Principal Investigator: JongSung Kim, MD         
Sub-Investigator: JooYoung Kwon, MD         
Konkuk Univ. Hospital Recruiting
Seoul, Korea, Republic of, 143-729
Contact: Hahn Young Kim       drdpl@freechal.com   
Sponsors and Collaborators
Asan Medical Center
Dong-A Pharmaceutical Co., Ltd.
Investigators
Principal Investigator: Jong Sung Kim, MD, PhD Department of Neurology, Asan Medical Center
  More Information

Additional Information:
No publications provided

Responsible Party: Jong Sung Kim/ Principal Investigator, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01278498     History of Changes
Other Study ID Numbers: EMOTION
Study First Received: January 18, 2011
Last Updated: June 14, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Asan Medical Center:
Escitalopram
Depression
Stroke

Additional relevant MeSH terms:
Depression
Depressive Disorder
Stroke
Behavioral Symptoms
Mood Disorders
Mental Disorders
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Dexetimide
Citalopram
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents

ClinicalTrials.gov processed this record on April 16, 2014