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

Primary Purpose

Depression

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Escitalopram
sugar pill
Sponsored by
Asan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Depression focused on measuring Escitalopram, Depression, Stroke

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kangwon National University Hospital
  • Kwandong University College of Medicine Myongji Hospital
  • Hanyang University Guri Hospital
  • Korea University Ansan Hospital
  • Daegu Fatima Hospital
  • Dongguk University International Hospital
  • Hallym Univesity Sacred Heart Hospital
  • Dong-A University Hospital
  • Dongsan Medical Center
  • Chungnam National University Hospital
  • Chosun University Hospital
  • Inha University Hospital
  • Severance Hospital
  • KyungHee University Medical Center
  • Asan Medical Center
  • Konkuk Univ. Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

escitalopram

placebo

Arm Description

prevention of poststroke depression in patients with acute stroke.

prevention of poststroke depression in patients with acute stroke.

Outcomes

Primary Outcome Measures

Occurrence rate of depression
Occurrence rate of depression (Montgomery-Asberg Depression Scale score ≥16)

Secondary Outcome Measures

Prevention of depression
Prevention of emotional incontinence
Prevention of anger proneness
Recovery of neurologic dysfunction
Improvement of cognitive function
Improvement of quality of life
Improvement of caregiver burden

Full Information

First Posted
January 18, 2011
Last Updated
October 8, 2014
Sponsor
Asan Medical Center
Collaborators
Dong-A ST Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01278498
Brief Title
The Preventive Effect of Escitalopram on Depression and Related Emotional Disorders in Acute Stroke Patients
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center
Collaborators
Dong-A ST Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Escitalopram, Depression, Stroke

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
444 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
escitalopram
Arm Type
Experimental
Arm Description
prevention of poststroke depression in patients with acute stroke.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
prevention of poststroke depression in patients with acute stroke.
Intervention Type
Drug
Intervention Name(s)
Escitalopram
Other Intervention Name(s)
lexacure
Intervention Description
first week:5mg 2nd week~12 week:10mg
Intervention Type
Drug
Intervention Name(s)
sugar pill
Other Intervention Name(s)
Placebo
Intervention Description
first week:5mg 2nd week~12 weeks:10mg
Primary Outcome Measure Information:
Title
Occurrence rate of depression
Description
Occurrence rate of depression (Montgomery-Asberg Depression Scale score ≥16)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Prevention of depression
Time Frame
3 months
Title
Prevention of emotional incontinence
Time Frame
3, 6 months
Title
Prevention of anger proneness
Time Frame
3, 6 months
Title
Recovery of neurologic dysfunction
Time Frame
3, 6 months
Title
Improvement of cognitive function
Time Frame
3, 6 months
Title
Improvement of quality of life
Time Frame
3, 6 months
Title
Improvement of caregiver burden
Time Frame
3, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jong Sung Kim, MD, PhD
Organizational Affiliation
Department of Neurology, Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kangwon National University Hospital
City
Chuncheon
State/Province
Gangwon
ZIP/Postal Code
200-722
Country
Korea, Republic of
Facility Name
Kwandong University College of Medicine Myongji Hospital
City
Gyeonggi-do
State/Province
Goyang
ZIP/Postal Code
412-270
Country
Korea, Republic of
Facility Name
Hanyang University Guri Hospital
City
Guri
State/Province
Gyeonggi-do
ZIP/Postal Code
471-701
Country
Korea, Republic of
Facility Name
Korea University Ansan Hospital
City
Ansan
State/Province
Gyeonggi
ZIP/Postal Code
425-707
Country
Korea, Republic of
Facility Name
Daegu Fatima Hospital
City
Daegu
State/Province
Gyeongsang
ZIP/Postal Code
701-600
Country
Korea, Republic of
Facility Name
Dongguk University International Hospital
City
Goyang
State/Province
Kyoungki-do
ZIP/Postal Code
410-773
Country
Korea, Republic of
Facility Name
Hallym Univesity Sacred Heart Hospital
City
Anyang
ZIP/Postal Code
430-070
Country
Korea, Republic of
Facility Name
Dong-A University Hospital
City
Busan
ZIP/Postal Code
602-715
Country
Korea, Republic of
Facility Name
Dongsan Medical Center
City
Daegu
ZIP/Postal Code
700-712
Country
Korea, Republic of
Facility Name
Chungnam National University Hospital
City
Daejeon
ZIP/Postal Code
301-721
Country
Korea, Republic of
Facility Name
Chosun University Hospital
City
Gwangju
ZIP/Postal Code
501-717
Country
Korea, Republic of
Facility Name
Inha University Hospital
City
Inchon
ZIP/Postal Code
400-103
Country
Korea, Republic of
Facility Name
Severance Hospital
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
KyungHee University Medical Center
City
Seoul
ZIP/Postal Code
130-702
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
Konkuk Univ. Hospital
City
Seoul
ZIP/Postal Code
143-729
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
32912058
Citation
Lee EJ, Kim JS, Chang DI, Park JH, Ahn SH, Cha JK, Heo JH, Sohn SI, Lee BC, Kim DE, Kim HY, Kim S, Kwon DY, Kim J, Seo WK, Lee J, Park SW, Koh SH, Kim JY, Choi-Kwon S, Kim MS, Lee JS. Post-Stroke Depressive Symptoms: Varying Responses to Escitalopram by Individual Symptoms and Lesion Location. J Geriatr Psychiatry Neurol. 2021 Nov;34(6):565-573. doi: 10.1177/0891988720957108. Epub 2020 Sep 10.
Results Reference
derived
PubMed Identifier
32023608
Citation
Lee EJ, Kim JS, Chang DI, Park JH, Ahn SH, Cha JK, Heo JH, Sohn SI, Lee BC, Kim DE, Kim HY, Kim S, Kwon DY, Kim J, Seo WK, Lee J, Park SW, Koh SH, Kim JY, Choi-Kwon S. Depressive Symptoms in Stroke Patients: Are There Sex Differences? Cerebrovasc Dis. 2020;49(1):19-25. doi: 10.1159/000506116. Epub 2020 Feb 5.
Results Reference
derived
PubMed Identifier
29886724
Citation
Lee EJ, Kim JS, Chang DI, Park JH, Ahn SH, Cha JK, Heo JH, Sohn SI, Lee BC, Kim DE, Kim HY, Kim S, Kwon DY, Kim J, Seo WK, Lee J, Park SW, Koh SH, Kim JY, Choi-Kwon S, Kim MS, Lee JS; EMOTION Investigators. Differences in Therapeutic Responses and Factors Affecting Post-Stroke Depression at a Later Stage According to Baseline Depression. J Stroke. 2018 May;20(2):258-267. doi: 10.5853/jos.2017.02712. Epub 2018 May 31.
Results Reference
derived
PubMed Identifier
29030421
Citation
Lee EJ, Oh MS, Kim JS, Chang DI, Park JH, Cha JK, Heo JH, Sohn SI, Kim DE, Kim HY, Kim J, Seo WK, Lee J, Park SW, Kim YJ, Lee BC; EMOTION investigators. Serotonin transporter gene polymorphisms may be associated with poststroke neurological recovery after escitalopram use. J Neurol Neurosurg Psychiatry. 2018 Mar;89(3):271-276. doi: 10.1136/jnnp-2017-316882. Epub 2017 Oct 13.
Results Reference
derived
PubMed Identifier
28012485
Citation
Kim JS, Lee EJ, Chang DI, Park JH, Ahn SH, Cha JK, Heo JH, Sohn SI, Lee BC, Kim DE, Kim HY, Kim S, Kwon DY, Kim J, Seo WK, Lee J, Park SW, Koh SH, Kim JY, Choi-Kwon S; EMOTION investigators. Efficacy of early administration of escitalopram on depressive and emotional symptoms and neurological dysfunction after stroke: a multicentre, double-blind, randomised, placebo-controlled study. Lancet Psychiatry. 2017 Jan;4(1):33-41. doi: 10.1016/S2215-0366(16)30417-5.
Results Reference
derived

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

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