title: Suicidal risk during controlled clinical investigations of fluvoxamine.
abstract: BACKGROUND
  Suicide is a serious risk factor in major depressive disorder. Paradoxical emergence of suicidal ideation or behavior during antidepressant treatment has been reported in isolated cases. An evaluation was undertaken to assess the risk of suicidality during treatment with fluvoxamine, a serotonin selective reuptake inhibitor.
  
  
  METHODS
  Meta-analyses were conducted on pooled data from double-blind, randomized, placebo-controlled, parallel-group clinical trials. The primary outcome measure was the suicide item of the Hamilton Rating Scale for Depression. Tests for emergence of substantial suicidal ideation and improvement or worsening in suicidal ideation were performed using the Mantel-Haenszel adjusted incidence difference. The Breslow-Day test was used to test for lack of homogeneity across trials. Secondary analysis, which consisted of Pearson's chi-square test, was used to confirm the Mantel-Haenszel result.
  
  
  RESULTS
  In comparison to placebo, fluvoxamine was associated with significantly greater improvement in suicidal ideation (p = .01) and significantly less worsening of suicidal ideation (p < .01). No differences were found in the emergence of substantial suicidal ideation.
  
  
  CONCLUSIONS
  These findings demonstrate that fluvoxamine is not associated with an increased risk of emergence of substantial suicidal thoughts among depressed patients. On the contrary, the results are suggestive of a protective effect of fluvoxamine upon the risk of suicidal ideation.
authors.affiliation: Solvay Pharmaceuticals, Marietta, GA 30062, USA.
authors.forename: C
authors.initials: C
authors.lastname: Letizia
authors.forename: B
authors.initials: B
authors.lastname: Kapik
authors.forename: W D
authors.initials: WD
authors.lastname: Flanders
mesh_terms: D000328:Adult; D000929:Antidepressive Agents, Tricyclic / Q000627:therapeutic use; D003866:Depressive Disorder / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D016666:Fluvoxamine / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010919:Placebos; D011569:Psychiatric Status Rating Scales; D012307:Risk Factors; D017367:Selective Serotonin Reuptake Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D013405:Suicide / Q000523:psychology* / Q000706:statistics & numerical data; D013406:Suicide, Attempted / Q000523:psychology / Q000706:statistics & numerical data
chemical_list: D000929:Antidepressive Agents, Tricyclic; D016666:Fluvoxamine; D010919:Placebos; D017367:Selective Serotonin Reuptake Inhibitors