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-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.
  
  
  RESULTS
  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).
  
  
  CONCLUSIONS
  Escitalopram did not significantly reduce moderate or severe depressive symptoms in patients with acute stroke.
  
  
  BACKGROUND
  Dong-A Pharmaceutical and Ministry for Health, Welfare, and Family Affairs, South Korea.
authors.affiliation: Department of Neurology, University of Ulsan, Asan Medical Center, Seoul, South Korea. Electronic address: jongskim@amc.seoul.kr.
authors.forename: Jong S
authors.initials: JS
authors.lastname: Kim
authors.affiliation: Department of Neurology, University of Ulsan, Asan Medical Center, Seoul, South Korea.
authors.forename: Eun-Jae
authors.initials: EJ
authors.lastname: Lee
authors.affiliation: Department of Neurology, Kyung Hee University Medical Center, Seoul, South Korea.
authors.forename: Dae-Il
authors.initials: DI
authors.lastname: Chang
authors.affiliation: Department of Neurology, Seonam University, Myongji Hospital, Goyang, South Korea.
authors.forename: Jong-Ho
authors.initials: JH
authors.lastname: Park
authors.affiliation: Department of Neurology, Chosun University Hospital, Gwangju, South Korea.
authors.forename: Seong Hwan
authors.initials: SH
authors.lastname: Ahn
authors.affiliation: Department of Neurology, Dong-A University Hospital, Busan, South Korea.
authors.forename: Jae-Kwan
authors.initials: JK
authors.lastname: Cha
authors.affiliation: Department of Neurology, Yonsei University, Severance Hospital, Seoul, South Korea.
authors.forename: Ji Hoe
authors.initials: JH
authors.lastname: Heo
authors.affiliation: Department of Neurology, Keimyung University, Dongsan Medical Center, Daegu, South Korea.
authors.forename: Sung-Il
authors.initials: SI
authors.lastname: Sohn
authors.affiliation: Department of Neurology, Hallym University, Sacred Heart Hospital, Pyungchon, South Korea.
authors.forename: Byung-Chul
authors.initials: BC
authors.lastname: Lee
authors.affiliation: Department of Neurology, Dongguk University, Ilsan Hospital, Goyang, South Korea.
authors.forename: Dong-Eog
authors.initials: DE
authors.lastname: Kim
authors.affiliation: Department of Neurology, Konkuk University School of Medicine, Seoul, South Korea.
authors.forename: Hahn Young
authors.initials: HY
authors.lastname: Kim
authors.affiliation: Department of Neurology, Kangwon National University College of Medicine, Chuncheon, South Korea.
authors.forename: Seongheon
authors.initials: S
authors.lastname: Kim
authors.affiliation: Department of Neurology, Korea University, Ansan Hospital, Ansan, South Korea.
authors.forename: Do-Young
authors.initials: DY
authors.lastname: Kwon
authors.affiliation: Department of Neurology, Chungnam University Hospital, Daejeon, South Korea.
authors.forename: Jei
authors.initials: J
authors.lastname: Kim
authors.affiliation: Department of Neurology, Sungkyunkwan University, Samsung Medical Center, Seoul South Korea.
authors.forename: Woo-Keun
authors.initials: WK
authors.lastname: Seo
authors.affiliation: Department of Neurology, Yeungnam University Hospital, Daegu, South Korea.
authors.forename: Jun
authors.initials: J
authors.lastname: Lee
authors.affiliation: Department of Neurology, Daegu Fatima Hospital, Daegu, South Korea.
authors.forename: Sang-Won
authors.initials: SW
authors.lastname: Park
authors.affiliation: Department of Neurology, Hanyang University, Guri Hospital, Guri, South Korea.
authors.forename: Seong-Ho
authors.initials: SH
authors.lastname: Koh
authors.affiliation: Department of Psychiatry, Hyundai Hospital, Eumseong, South Korea.
authors.forename: Jin Young
authors.initials: JY
authors.lastname: Kim
authors.affiliation: College of Nursing, The Research Institute of Nursing Science, Seoul National University, Seoul, South Korea.
authors.forename: Smi
authors.initials: S
authors.lastname: Choi-Kwon
mesh_terms: D000368:Aged; D018687:Antidepressive Agents, Second-Generation / Q000008:administration & dosage*; D015283:Citalopram / Q000008:administration & dosage*; D003863:Depression / Q000517:prevention & control*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004644:Emotions; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009422:Nervous System Diseases / Q000517:prevention & control*; D017367:Selective Serotonin Reuptake Inhibitors / Q000008:administration & dosage*; D020521:Stroke / Q000503:physiopathology* / Q000523:psychology*; D016896:Treatment Outcome
chemical_list: D018687:Antidepressive Agents, Second-Generation; D015283:Citalopram; D017367:Selective Serotonin Reuptake Inhibitors