title: Dosage, effectiveness, and safety of sertraline treatment for posttraumatic stress disorder in a Japanese clinical setting: a retrospective study.
abstract: BACKGROUND
  Many of the posttraumatic stress disorder (PTSD) treatment guidelines recognize the use of selective serotonin reuptake inhibitors as first-line pharmacological treatment. In Japan, there were no published studies investigating the effectiveness and safety of sertraline for PTSD in a clinical setting.
  
  
  METHODS
  We conducted a retrospective medical chart review of the dosage, effectiveness, and safety of sertraline for the PTSD treatment in Japan. Data were collected from medical charts of patients of PTSD, caused by various types of trauma, who were treated with sertraline between July 2006 and October 2012 during their regular clinical practice. To evaluate the effectiveness, the investigators retrospectively assessed the severity and improvement of the symptoms using the Clinical Global Impressions - Severity and the Clinical Global Impressions - Improvement.
  
  
  RESULTS
  The study population was 122 Japanese patients aged ≥18 years with a diagnosis of PTSD who were treated with sertraline (median duration, 10.6 months). Doses ranged from 12.5 to 150 mg/day, mostly 25 and 50 mg/day. The median duration of observation was 10.8 months. Out of those, 50% of patients were regarded as responders by using the Clinical Global Impressions - Improvement at the end of sertraline treatment or the last observation. Two-thirds (65.6%) of patients improved in the severity of PTSD, as assessed by Clinical Global Impressions - Severity, whereas 32.8% showed no change, and 1.6% worsened. Subgroups analyses and logistic regression analyses suggested that the type of traumatic events was the factor with the highest influence on the response rate. The adverse events in this chart review were consistent with the known safety profile of sertraline. There were no reports of serious or severe adverse events considered to be related to sertraline.
  
  
  CONCLUSIONS
  Our study suggested the effectiveness of sertraline for the treatment of PTSD in a Japanese clinical setting, and the obtained safety profile was consistent with the generally known safety profile of sertraline.
  
  
  BACKGROUND
  ClinicalTrials.gov (Identification No. NCT01607593 ). Registered May 21, 2012.
authors.affiliation: Institute of Women's Health, Tokyo Women's Medical University, Shinjuku, Tokyo, Japan.
authors.forename: Toshiko
authors.initials: T
authors.lastname: Kamo
authors.affiliation: Department of Disaster Psychiatry, Fukushima Medical University, Fukushima, Fukushima, Japan.|Department of Neuropsychiatry, Kurume University School of Medicine, Kurume, Fukuoka, Japan.
authors.forename: Masaharu
authors.initials: M
authors.lastname: Maeda
authors.affiliation: Department of Neuropsychiatry, Kurume University School of Medicine, Kurume, Fukuoka, Japan.
authors.forename: Misari
authors.initials: M
authors.lastname: Oe
authors.affiliation: Hyogo Institute for Traumatic Stress, Kobe, Hyogo, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Kato
authors.affiliation: Department of Psychiatry, National Defense Medical College, Tokorozawa, Saitama, Japan.
authors.forename: Jun
authors.initials: J
authors.lastname: Shigemura
authors.affiliation: Clinical Statistics, Pfizer Japan Inc., Shibuya, Tokyo, Japan.
authors.forename: Kazuhiko
authors.initials: K
authors.lastname: Kuribayashi
authors.affiliation: Clinical Research, Pfizer Japan Inc., Shibuya, Tokyo, Japan. Yuko.Hoshino@pfizer.com.
authors.forename: Yuko
authors.initials: Y
authors.lastname: Hoshino
mesh_terms: D000328:Adult; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D061214:Patient Safety; D012189:Retrospective Studies; D017367:Selective Serotonin Reuptake Inhibitors / Q000008:administration & dosage*; D020280:Sertraline / Q000008:administration & dosage*; D013313:Stress Disorders, Post-Traumatic / Q000175:diagnosis / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D017367:Selective Serotonin Reuptake Inhibitors; D020280:Sertraline
keywords: Antidepressant; Chart review; Japan; Pharmacotherapy; Posttraumatic stress disorder (PTSD); Selective serotonin reuptake inhibitors (SSRI); Sertraline