title: Eicosapentaenoic acid as an add-on to antidepressant medication for co-morbid major depression in patients with diabetes mellitus: a randomized, double-blind placebo-controlled study.
abstract: BACKGROUND
  Depression is common in individuals with diabetes. The present study is the first randomized controlled trial to test the efficacy of omega-3 ethyl-eicosapentaenoic acid (E-EPA) as adjuvant to antidepressant medication in the treatment of depression in adults with diabetes mellitus.
  
  
  METHODS
  In the VU University Medical Center, we conducted a 12-week, placebo-controlled, double-blind, parallel-group intervention study of E-EPA (1g/day) versus placebo in 25 diabetes patients meeting DSM-IV criteria for major depressive disorder, who were already using antidepressant medication. The primary outcome was severity of depressive symptoms, assessed by the Montgomery Asberg Depression Rating Scale (MADRS) at baseline and 12-week follow-up at two-weekly intervals. Blood samples were collected at baseline and at 12-week follow-up to determine EPA levels in erythrocyte membranes. Data were analyzed with ANOVA for repeated measures.
  
  
  RESULTS
  Thirteen participants were randomly assigned to E-EPA; 12 participants were given placebo. At 12-week follow-up, erythrocyte membranes from patients receiving E-EPA contained tripled levels of EPA, while no changes were noted in participants receiving placebo. In both groups, depressive symptoms significantly decreased over time (F=21.14, p<0.001), yet no significant differences were found between those treated with E-EPA versus placebo (F=1.63, p=0.17).
  
  
  CONCLUSIONS
  Although having sufficient study power, this study had a relatively small sample size. Small effects could not be detected, and dose-dependent effects could not be studied.
  
  
  CONCLUSIONS
  No evidence was found for the efficacy of adding E-EPA to antidepressants in reducing depressive symptoms in diabetic patients with co-morbid depression.
authors.affiliation: CoRPS - Center of Research on Psychology in Somatic diseases, Department of Medical Psychology and Neuropsychology, Tilburg University, Tilburg, The Netherlands.
authors.forename: M
authors.initials: M
authors.lastname: Bot
authors.forename: F
authors.initials: F
authors.lastname: Pouwer
authors.forename: J
authors.initials: J
authors.lastname: Assies
authors.forename: E H J M
authors.initials: EH
authors.lastname: Jansen
authors.forename: M
authors.initials: M
authors.lastname: Diamant
authors.forename: F J
authors.initials: FJ
authors.lastname: Snoek
authors.forename: A T F
authors.initials: AT
authors.lastname: Beekman
authors.forename: P
authors.initials: P
authors.lastname: de Jonge
mesh_terms: D000277:Adjuvants, Pharmaceutic / Q000627:therapeutic use; D000928:Antidepressive Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D003865:Major Depressive Disorder / Q000150:complications* / Q000188:drug therapy; D048909:Diabetes Complications / Q000188:drug therapy / Q000523:psychology*; D004311:Double-Blind Method; D015118:Eicosapentaenoic Acid / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011569:Psychiatric Status Rating Scales; D016896:Treatment Outcome
chemical_list: D000277:Adjuvants, Pharmaceutic; D000928:Antidepressive Agents; D015118:Eicosapentaenoic Acid