title: Tachikawa project for prevention of posttraumatic stress disorder with polyunsaturated fatty acid (TPOP): study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Preclinical and clinical studies suggest that supplementation with omega-3 fatty acids after trauma might reduce subsequent posttraumatic stress disorder (PTSD). To date, we have shown in an open trial that PTSD symptoms in critically injured patients can be reduced by taking omega-3 fatty acids, hypothesized to stimulate hippocampal neurogenesis. The primary aim of the present randomized controlled trial is to examine the efficacy of omega-3 fatty acid supplementation in the secondary prevention of PTSD following accidental injury, as compared with placebo. This paper describes the rationale and protocol of this trial.
  
  
  METHODS
  The Tachikawa Project for Prevention of Posttraumatic Stress Disorder with Polyunsaturated Fatty Acid (TPOP) is a double-blinded, parallel group, randomized controlled trial to assess whether omega-3 fatty acid supplementation can prevent PTSD symptoms among accident-injured patients consecutively admitted to an intensive care unit. We plan to recruit accident-injured patients and follow them prospectively for 12 weeks. Enrolled patients will be randomized to either the omega-3 fatty acid supplement group (1,470 mg docosahexaenoic acid and 147 mg eicosapentaenoic acid daily) or placebo group. Primary outcome is score on the Clinician-Administered PTSD Scale (CAPS). We will need to randomize 140 injured patients to have 90% power to detect a 10-point difference in mean CAPS scores with omega-3 fatty acid supplementation compared with placebo. Secondary measures are diagnosis of PTSD and major depressive disorder, depressive symptoms, physiologic response in the experiment using script-driven imagery and acoustic stimulation, serum brain-derived neurotrophic factor, health-related quality of life, resilience, and aggression. Analyses will be by intent to treat. The trial was initiated on December 13 2008, with 104 subjects randomized by November 30 2012.
  
  
  CONCLUSIONS
  This study promises to be the first trial to provide a novel prevention strategy for PTSD among traumatized people.
  
  
  BACKGROUND
  ClinicalTrials.gov Identifier NCT00671099.
authors.affiliation: Department of Psychiatry, National Disaster Medical Center, 3256 Midoricho, 190-0014, Tachikawa, Tokyo, Japan. yutaka@ncnp.go.jp
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Matsuoka
authors.forename: Daisuke
authors.initials: D
authors.lastname: Nishi
authors.forename: Naohiro
authors.initials: N
authors.lastname: Yonemoto
authors.forename: Kei
authors.initials: K
authors.lastname: Hamazaki
authors.forename: Kenta
authors.initials: K
authors.lastname: Matsumura
authors.forename: Hiroko
authors.initials: H
authors.lastname: Noguchi
authors.forename: Kenji
authors.initials: K
authors.lastname: Hashimoto
authors.forename: Tomohito
authors.initials: T
authors.lastname: Hamazaki
mesh_terms: D019208:Brain-Derived Neurotrophic Factor / Q000097:blood; D019587:Dietary Supplements; D004281:Docosahexaenoic Acids / Q000627:therapeutic use; D004311:Double-Blind Method; D015118:Eicosapentaenoic Acid / Q000627:therapeutic use; D015525:Fatty Acids, Omega-3 / Q000627:therapeutic use; D005231:Fatty Acids, Unsaturated / Q000097:blood / Q000627:therapeutic use*; D006624:Hippocampus / Q000187:drug effects; D006801:Humans; D011569:Psychiatric Status Rating Scales; D011581:Psychological Tests; D013313:Stress Disorders, Post-Traumatic / Q000517:prevention & control*; D014947:Wounds and Injuries / Q000523:psychology
chemical_list: D019208:Brain-Derived Neurotrophic Factor; D015525:Fatty Acids, Omega-3; D005231:Fatty Acids, Unsaturated; D004281:Docosahexaenoic Acids; D015118:Eicosapentaenoic Acid