The Preventive Effect of Escitalopram on Depression and Related Emotional Disorders in Acute Stroke Patients (EMOTION)
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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 |
- Occurrence rate of depression [ Time Frame: 3 months ] [ Designated as safety issue: No ]Occurrence rate of depression (Montgomery-Asberg Depression Scale score ≥16)
- 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 |
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| Contact: Jong Sung Kim, MD,PhD | 82-2-3010-3442 | jongskim@amc.seoul.kr |
| 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 | |
| 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 May 16, 2013