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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Dong-A ST Co., Ltd.
Information provided by (Responsible Party):
Jongsung Kim, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01278498
First received: January 18, 2011
Last updated: October 8, 2014
Last verified: October 2014
  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 2015
Estimated Primary Completion Date: December 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01278498

Locations
Korea, Republic of
Kangwon National University Hospital
Chuncheon, Gangwon, Korea, Republic of, 200-722
Kwandong University College of Medicine Myongji Hospital
Gyeonggi-do, Goyang, Korea, Republic of, 412-270
Hanyang University Guri Hospital
Guri, Gyeonggi-do, Korea, Republic of, 471-701
Korea University Ansan Hospital
Ansan, Gyeonggi, Korea, Republic of, 425-707
Daegu Fatima Hospital
Daegu, Gyeongsang, Korea, Republic of, 701-600
Dongguk University International Hospital
Goyang, Kyoungki-do, Korea, Republic of, 410-773
Hallym Univesity Sacred Heart Hospital
Anyang, Korea, Republic of, 430-070
Dong-A University Hospital
Busan, Korea, Republic of, 602-715
Dongsan Medical Center
Daegu, Korea, Republic of, 700-712
Chungnam National University Hospital
Daejeon, Korea, Republic of, 301-721
Chosun University Hospital
Gwangju, Korea, Republic of, 501-717
Inha University Hospital
Inchon, Korea, Republic of, 400-103
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Konkuk Univ. Hospital
Seoul, Korea, Republic of, 143-729
KyungHee University Medical Center
Seoul, Korea, Republic of, 130-702
Severance Hospital
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Asan Medical Center
Dong-A ST 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: Jongsung Kim, professor, department of neurology, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01278498     History of Changes
Other Study ID Numbers: EMOTION
Study First Received: January 18, 2011
Last Updated: October 8, 2014
Health Authority: Korea: Food and Drug Administration

Keywords provided by Asan Medical Center:
Escitalopram
Depression
Stroke

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

ClinicalTrials.gov processed this record on November 27, 2014