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

NCT01278498 | Unknown Phase 4 DMC

• 1 other identifier: EMOTION
• Study Type: interventional
• Target: 444
• Locations: 1 country
• Sites: 16

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

Conditions

Depression

Keywords

Escitalopram; Depression; Stroke

Outcome Measures

Primary Outcomes (1)

• Occurrence rate of depression

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

  3 months

Secondary Outcomes (7)

• Prevention of depression

  3 months

• Prevention of emotional incontinence

  3, 6 months

• Prevention of anger proneness

  3, 6 months

• Recovery of neurologic dysfunction

  3, 6 months

• Improvement of cognitive function

  3, 6 months

Study Arms (2)

escitalopram

EXPERIMENTAL

prevention of poststroke depression in patients with acute stroke.

Drug: Escitalopram

placebo

PLACEBO COMPARATOR

prevention of poststroke depression in patients with acute stroke.

Drug: sugar pill

Interventions

Escitalopram DRUG

first week:5mg 2nd week\~12 week:10mg

Also known as: lexacure

escitalopram

sugar pill DRUG

first week:5mg 2nd week\~12 weeks:10mg

Also known as: Placebo

placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Asan Medical Center: lead
• Dong-A ST Co., Ltd.: collaborator

Study Sites (16)

Kangwon National University Hospital

Chuncheon, Gangwon-do, 200-722, South Korea

Location

Kwandong University College of Medicine Myongji Hospital

Gyeonggi-do, Goyang, 412-270, South Korea

Location

Korea University Ansan Hospital

Ansan, Gyeonggi-do, 425-707, South Korea

Location

Hanyang University Guri Hospital

Guri-si, Gyeonggi-do, 471-701, South Korea

Location

Daegu Fatima Hospital

Daegu, Gyeongsang, 701-600, South Korea

Location

Dongguk University International Hospital

Goyang, Kyoungki-do, 410-773, South Korea

Location

Hallym Univesity Sacred Heart Hospital

Anyang, 430-070, South Korea

Location

Dong-A University Hospital

Busan, 602-715, South Korea

Location

Dongsan Medical Center

Daegu, 700-712, South Korea

Location

Chungnam National University Hospital

Daejeon, 301-721, South Korea

Location

Chosun University Hospital

Gwangju, 501-717, South Korea

Location

Inha University Hospital

Inchon, 400-103, South Korea

Location

Severance Hospital

Seoul, 120-752, South Korea

Location

KyungHee University Medical Center

Seoul, 130-702, South Korea

Location

Asan Medical Center

Seoul, 138-736, South Korea

Location

Konkuk Univ. Hospital

Seoul, 143-729, South Korea

Location

Related Publications (5)

• 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.

  PMID: 32912058 DERIVED

• 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.

  PMID: 32023608 DERIVED

• 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.

  PMID: 29886724 DERIVED

• 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.

  PMID: 29030421 DERIVED

• 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.

  PMID: 28012485 DERIVED

MeSH Terms

Conditions

Depression; Stroke

Interventions

Escitalopram; Sugars

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Carbohydrates

Study Officials

• Jong Sung Kim, MD, PhD

  Department of Neurology, Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor, department of neurology

Study Record Dates

• First Submitted: January 18, 2011
• First Posted: January 19, 2011
• Study Start: January 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2015
• Last Updated: October 9, 2014

Record last verified: 2014-10

Locations

KR (16)