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DepressionPhase 4EMOTIONNCT01278498

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

A Phase 4 study testing Escitalopram and sugar pill in people with Depression, run by Asan Medical Center at 16 sites in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Depression
What is being tested?
Escitalopram and sugar pill
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
444 participants
Where
16 sitesSouth Korea
Study dates
Jan 2011to Dec 2015
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 9Show fewer
  • 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

Who cannot join

  • 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
Show all 16Show fewer
  • 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

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

South Korea16 sites

  • Korea University Ansan Hospital

    Ansan, Gyeonggi-do, 425-707

  • Hallym Univesity Sacred Heart Hospital

    Anyang, 430-070

  • Dong-A University Hospital

    Busan, 602-715

  • Kangwon National University Hospital

    Chuncheon, Gangwon-do, 200-722

  • Daegu Fatima Hospital

    Daegu, Gyeongsang, 701-600

  • Dongsan Medical Center

    Daegu, 700-712

  • Chungnam National University Hospital

    Daejeon, 301-721

  • Dongguk University International Hospital

    Goyang, Kyoungki-do, 410-773

  • Hanyang University Guri Hospital

    Guri-si, Gyeonggi-do, 471-701

  • Chosun University Hospital

    Gwangju, 501-717

  • Kwandong University College of Medicine Myongji Hospital

    Gyeonggi-do, Goyang, 412-270

  • Inha University Hospital

    Inchon, 400-103

  • Severance Hospital

    Seoul, 120-752

  • KyungHee University Medical Center

    Seoul, 130-702

  • Asan Medical Center

    Seoul, 138-736

  • Konkuk Univ. Hospital

    Seoul, 143-729

Other trials in South Korea

About this study

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

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

Read the 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.

Conditions
Depression
Being tested
Escitalopram, sugar pill
Keywords
Escitalopram, Depression, Stroke
Medical subject headings
Depression, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EscitalopramDrug

    Also called lexacure

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

  • sugar pillDrug

    Also called Placebo

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

Study groups in NCT01278498
Study groupRoleWhat they receive
escitalopramExperimentalprevention of poststroke depression in patients with acute stroke.
Receives: Drug: Escitalopram
placeboPlacebo comparatorprevention of poststroke depression in patients with acute stroke.
Receives: Drug: sugar pill

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Occurrence rate of depression

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

    Measured: 3 months

Secondary outcomes (7)

  1. Prevention of depression

    Measured: 3 months

  2. Prevention of emotional incontinence

    Measured: 3, 6 months

  3. Prevention of anger proneness

    Measured: 3, 6 months

  4. Recovery of neurologic dysfunction

    Measured: 3, 6 months

  5. Improvement of cognitive function

    Measured: 3, 6 months

  6. Improvement of quality of life

    Measured: 3, 6 months

  7. Improvement of caregiver burden

    Measured: 3, 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jan 2011 (estimated)
  2. Study startJan 2011
  3. Primary completionDec 2014 (estimated)
  4. Study completionDec 2015 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
444 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01278498
Sponsor's protocol ID
EMOTION
Acronym
EMOTION
Status last verified
Oct 2014
First submitted
18 Jan 2011
Last updated
9 Oct 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 32912058

  • 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.

    PubMed 32023608

  • 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.

    PubMed 29886724

  • 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.

    PubMed 29030421

  • 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.

    PubMed 28012485

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Escitalopram and sugar pill in people with Depression, run by Asan Medical Center at 16 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence rate of depression (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01278498, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2014.

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