title: Efficacy of duloxetine for the treatment of generalized anxiety disorder: implications for primary care physicians.
abstract: OBJECTIVE
  This study examined the efficacy and tolerability of duloxetine, a dual reuptake inhibitor of serotonin and norepinephrine, for the treatment of patients with generalized anxiety disorder (GAD).
  
  
  METHODS
  Patients were ≥ 18 years old and recruited from 5 European countries, the United States, and South Africa. The study had a 9-week, multicenter, randomized, double-blind, fixed-dose, placebo-controlled, parallel-group design. A total of 513 patients (mean age = 43.8 years; 67.8% female) with a DSM-IV-defined GAD diagnosis received treatment with duloxetine 60 mg/day (N = 168), duloxetine 120 mg/day (N = 170), or placebo (N = 175). The primary efficacy measure was the Hamilton Rating Scale for Anxiety (HAM-A) total score. Secondary measures included the Sheehan Disability Scale, HAM-A psychic and somatic anxiety factor scores, and HAM-A response, remission, and sustained improvement rates. The study was conducted from July 2004 to September 2005.
  
  
  RESULTS
  Both groups of duloxetine-treated patients demonstrated significantly greater improvements in anxiety symptom severity compared with placebo-treated patients as measured by HAM-A total score and HAM-A psychic and somatic anxiety factor scores (p values ranged from ≤ .01 to ≤ .001). Duloxetine-treated patients had greater functional improvements in Sheehan Disability Scale global and specific domain scores (p ≤ .001) than placebo-treated patients. Both duloxetine doses also resulted in significantly greater HAM-A response, remission, and sustained improvement rates compared with placebo (p values ranged from ≤ .01 to ≤ .001). The rate of study discontinuation due to adverse events was 11.3% for duloxetine 60 mg and 15.3% for duloxetine 120 mg versus 2.3% for placebo (p ≤ .001).
  
  
  CONCLUSIONS
  The results of this study demonstrate that duloxetine 60 mg/day and 120 mg/day were efficacious and well tolerated and thus may provide primary care physicians with a useful pharmacologic intervention for GAD.
  
  
  BACKGROUND
  ClinicalTrials.gov identifier NCT00122824.
authors.affiliation: University of Kuopio, Kuopio, Finland. hannujuhani.koponen@uku.fi
authors.forename: Hannu
authors.initials: H
authors.lastname: Koponen
authors.forename: Christer
authors.initials: C
authors.lastname: Allgulander
authors.forename: Janelle
authors.initials: J
authors.lastname: Erickson
authors.forename: Eduardo
authors.initials: E
authors.lastname: Dunayevich
authors.forename: Yili
authors.initials: Y
authors.lastname: Pritchett
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Detke
authors.forename: Susan G
authors.initials: SG
authors.lastname: Ball
authors.forename: James M
authors.initials: JM
authors.lastname: Russell