Efficacy of early administration of escitalopram on depressive and emotional symptoms and neurological dysfunction after stroke

a multicentre, double-blind, randomised, placebo-controlled study

EMOTION investigators

Research output: Contribution to journalArticle

19 Citations (Scopus)

Abstract

Background Mood and emotional disturbances are common in patients with stroke, and adversely affect the clinical outcome. We aimed to evaluate the efficacy of early administration of escitalopram to reduce moderate or severe depressive symptoms and improve emotional and neurological dysfunction in patients with stroke. Methods This was a placebo controlled, double-blind trial done at 17 centres in South Korea. Patients who had had an acute stroke within the past 21 days were randomly assigned in a 1:1 ratio to receive oral escitalopram (10 mg/day) or placebo for 3 months. Randomisation was done with permuted blocks stratified by centre, via a web-based system. The primary endpoint was the frequency of moderate or severe depressive symptoms (Montgomery-Åsberg Depression Rating Scale [MADRS] ≥16). Endpoints were assessed at 3 months after randomisation in the full analysis set (patients who took study medication and underwent assessment of primary endpoint after randomisation), in all patients who were enrolled and randomly assigned (intention to treat), and in all patients who completed the trial (per-protocol analysis). This trial is registered with ClinicalTrials.gov, number NCT01278498. Findings Between Jan 27, 2011, and June 30, 2014, 478 patients were assigned to placebo (n=237) or escitalopram (n=241); 405 were included in the full analysis set (195 in the placebo group, 210 in the escitalopram group). The primary outcome did not differ by study group in the full analysis set (25 [13%] patients in the placebo group vs 27 [13%] in the escitalopram group; odds ratio [OR] 1·00, 95% CI 0·56–1·80; p>0·99) or in the intention-to-treat analysis (34 [14%] vs 35 [15%]; OR 1·01, 95% CI 0·61–1·69, p=0·96). The study medication was generally well tolerated; the most common adverse events were constipation (14 [6%] patients who received placebo vs 14 [6%] who received escitalopram), muscle pain (16 [7%] vs ten [4%]), and insomnia (12 [5%] vs 12 [5%]). Diarrhoea was more common in the escitalopram group (nine [4%] patients) than in the placebo group (two [1%] patients). Interpretation Escitalopram did not significantly reduce moderate or severe depressive symptoms in patients with acute stroke. Funding Dong-A Pharmaceutical and Ministry for Health, Welfare, and Family Affairs, South Korea.

Original languageEnglish
Pages (from-to)33-41
Number of pages9
JournalThe Lancet Psychiatry
Volume4
Issue number1
DOIs
Publication statusPublished - 2017 Jan 1

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Citalopram
Stroke
Placebos
Depression
Random Allocation
Republic of Korea
Odds Ratio
Intention to Treat Analysis
Affective Symptoms
Family Health
Myalgia
Sleep Initiation and Maintenance Disorders
Constipation
Clinical Protocols
Diarrhea

All Science Journal Classification (ASJC) codes

  • Psychiatry and Mental health
  • Biological Psychiatry

Cite this

@article{e854eefc2adb4a61a2272784de424495,
title = "Efficacy of early administration of escitalopram on depressive and emotional symptoms and neurological dysfunction after stroke: a multicentre, double-blind, randomised, placebo-controlled study",
abstract = "Background Mood and emotional disturbances are common in patients with stroke, and adversely affect the clinical outcome. We aimed to evaluate the efficacy of early administration of escitalopram to reduce moderate or severe depressive symptoms and improve emotional and neurological dysfunction in patients with stroke. Methods This was a placebo controlled, double-blind trial done at 17 centres in South Korea. Patients who had had an acute stroke within the past 21 days were randomly assigned in a 1:1 ratio to receive oral escitalopram (10 mg/day) or placebo for 3 months. Randomisation was done with permuted blocks stratified by centre, via a web-based system. The primary endpoint was the frequency of moderate or severe depressive symptoms (Montgomery-{\AA}sberg Depression Rating Scale [MADRS] ≥16). Endpoints were assessed at 3 months after randomisation in the full analysis set (patients who took study medication and underwent assessment of primary endpoint after randomisation), in all patients who were enrolled and randomly assigned (intention to treat), and in all patients who completed the trial (per-protocol analysis). This trial is registered with ClinicalTrials.gov, number NCT01278498. Findings Between Jan 27, 2011, and June 30, 2014, 478 patients were assigned to placebo (n=237) or escitalopram (n=241); 405 were included in the full analysis set (195 in the placebo group, 210 in the escitalopram group). The primary outcome did not differ by study group in the full analysis set (25 [13{\%}] patients in the placebo group vs 27 [13{\%}] in the escitalopram group; odds ratio [OR] 1·00, 95{\%} CI 0·56–1·80; p>0·99) or in the intention-to-treat analysis (34 [14{\%}] vs 35 [15{\%}]; OR 1·01, 95{\%} CI 0·61–1·69, p=0·96). The study medication was generally well tolerated; the most common adverse events were constipation (14 [6{\%}] patients who received placebo vs 14 [6{\%}] who received escitalopram), muscle pain (16 [7{\%}] vs ten [4{\%}]), and insomnia (12 [5{\%}] vs 12 [5{\%}]). Diarrhoea was more common in the escitalopram group (nine [4{\%}] patients) than in the placebo group (two [1{\%}] patients). Interpretation Escitalopram did not significantly reduce moderate or severe depressive symptoms in patients with acute stroke. Funding Dong-A Pharmaceutical and Ministry for Health, Welfare, and Family Affairs, South Korea.",
author = "{EMOTION investigators} and Kim, {Jong S.} and Lee, {Eun Jae} and Chang, {Dae Il} and Park, {Jong Ho} and Ahn, {Seong Hwan} and Cha, {Jae Kwan} and Jihoe Heo and Sohn, {Sung Il} and Lee, {Byung Chul} and Kim, {Dong Eog} and Kim, {Hahn Young} and Seongheon Kim and Kwon, {Do Young} and Jei Kim and Seo, {Woo Keun} and Jun Lee and Park, {Sang Won} and Koh, {Seong Ho} and Kim, {Jin Young} and Smi Choi-Kwon",
year = "2017",
month = "1",
day = "1",
doi = "10.1016/S2215-0366(16)30417-5",
language = "English",
volume = "4",
pages = "33--41",
journal = "The Lancet Psychiatry",
issn = "2215-0366",
publisher = "Elsevier Limited",
number = "1",

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TY - JOUR

T1 - Efficacy of early administration of escitalopram on depressive and emotional symptoms and neurological dysfunction after stroke

T2 - a multicentre, double-blind, randomised, placebo-controlled study

AU - EMOTION investigators

AU - Kim, Jong S.

AU - Lee, Eun Jae

AU - Chang, Dae Il

AU - Park, Jong Ho

AU - Ahn, Seong Hwan

AU - Cha, Jae Kwan

AU - Heo, Jihoe

AU - Sohn, Sung Il

AU - Lee, Byung Chul

AU - Kim, Dong Eog

AU - Kim, Hahn Young

AU - Kim, Seongheon

AU - Kwon, Do Young

AU - Kim, Jei

AU - Seo, Woo Keun

AU - Lee, Jun

AU - Park, Sang Won

AU - Koh, Seong Ho

AU - Kim, Jin Young

AU - Choi-Kwon, Smi

PY - 2017/1/1

Y1 - 2017/1/1

N2 - Background Mood and emotional disturbances are common in patients with stroke, and adversely affect the clinical outcome. We aimed to evaluate the efficacy of early administration of escitalopram to reduce moderate or severe depressive symptoms and improve emotional and neurological dysfunction in patients with stroke. Methods This was a placebo controlled, double-blind trial done at 17 centres in South Korea. Patients who had had an acute stroke within the past 21 days were randomly assigned in a 1:1 ratio to receive oral escitalopram (10 mg/day) or placebo for 3 months. Randomisation was done with permuted blocks stratified by centre, via a web-based system. The primary endpoint was the frequency of moderate or severe depressive symptoms (Montgomery-Åsberg Depression Rating Scale [MADRS] ≥16). Endpoints were assessed at 3 months after randomisation in the full analysis set (patients who took study medication and underwent assessment of primary endpoint after randomisation), in all patients who were enrolled and randomly assigned (intention to treat), and in all patients who completed the trial (per-protocol analysis). This trial is registered with ClinicalTrials.gov, number NCT01278498. Findings Between Jan 27, 2011, and June 30, 2014, 478 patients were assigned to placebo (n=237) or escitalopram (n=241); 405 were included in the full analysis set (195 in the placebo group, 210 in the escitalopram group). The primary outcome did not differ by study group in the full analysis set (25 [13%] patients in the placebo group vs 27 [13%] in the escitalopram group; odds ratio [OR] 1·00, 95% CI 0·56–1·80; p>0·99) or in the intention-to-treat analysis (34 [14%] vs 35 [15%]; OR 1·01, 95% CI 0·61–1·69, p=0·96). The study medication was generally well tolerated; the most common adverse events were constipation (14 [6%] patients who received placebo vs 14 [6%] who received escitalopram), muscle pain (16 [7%] vs ten [4%]), and insomnia (12 [5%] vs 12 [5%]). Diarrhoea was more common in the escitalopram group (nine [4%] patients) than in the placebo group (two [1%] patients). Interpretation Escitalopram did not significantly reduce moderate or severe depressive symptoms in patients with acute stroke. Funding Dong-A Pharmaceutical and Ministry for Health, Welfare, and Family Affairs, South Korea.

AB - Background Mood and emotional disturbances are common in patients with stroke, and adversely affect the clinical outcome. We aimed to evaluate the efficacy of early administration of escitalopram to reduce moderate or severe depressive symptoms and improve emotional and neurological dysfunction in patients with stroke. Methods This was a placebo controlled, double-blind trial done at 17 centres in South Korea. Patients who had had an acute stroke within the past 21 days were randomly assigned in a 1:1 ratio to receive oral escitalopram (10 mg/day) or placebo for 3 months. Randomisation was done with permuted blocks stratified by centre, via a web-based system. The primary endpoint was the frequency of moderate or severe depressive symptoms (Montgomery-Åsberg Depression Rating Scale [MADRS] ≥16). Endpoints were assessed at 3 months after randomisation in the full analysis set (patients who took study medication and underwent assessment of primary endpoint after randomisation), in all patients who were enrolled and randomly assigned (intention to treat), and in all patients who completed the trial (per-protocol analysis). This trial is registered with ClinicalTrials.gov, number NCT01278498. Findings Between Jan 27, 2011, and June 30, 2014, 478 patients were assigned to placebo (n=237) or escitalopram (n=241); 405 were included in the full analysis set (195 in the placebo group, 210 in the escitalopram group). The primary outcome did not differ by study group in the full analysis set (25 [13%] patients in the placebo group vs 27 [13%] in the escitalopram group; odds ratio [OR] 1·00, 95% CI 0·56–1·80; p>0·99) or in the intention-to-treat analysis (34 [14%] vs 35 [15%]; OR 1·01, 95% CI 0·61–1·69, p=0·96). The study medication was generally well tolerated; the most common adverse events were constipation (14 [6%] patients who received placebo vs 14 [6%] who received escitalopram), muscle pain (16 [7%] vs ten [4%]), and insomnia (12 [5%] vs 12 [5%]). Diarrhoea was more common in the escitalopram group (nine [4%] patients) than in the placebo group (two [1%] patients). Interpretation Escitalopram did not significantly reduce moderate or severe depressive symptoms in patients with acute stroke. Funding Dong-A Pharmaceutical and Ministry for Health, Welfare, and Family Affairs, South Korea.

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U2 - 10.1016/S2215-0366(16)30417-5

DO - 10.1016/S2215-0366(16)30417-5

M3 - Article

VL - 4

SP - 33

EP - 41

JO - The Lancet Psychiatry

JF - The Lancet Psychiatry

SN - 2215-0366

IS - 1

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