title: Efficacy and safety of duloxetine in the treatment of older adult patients with generalized anxiety disorder: a randomized, double-blind, placebo-controlled trial.
abstract: OBJECTIVE
  This was a flexible-dosed study to evaluate the efficacy and safety of duloxetine 30-120 mg once daily in the treatment of generalized anxiety disorder (GAD) in older adult patients.
  
  
  METHODS
  Patients with GAD, who were at least 65 years of age, were randomly assigned to double-blind treatment with either duloxetine (N = 151) or placebo (N = 140). The primary efficacy measure was the Hamilton Anxiety Rating Scale (HAM-A) total score, and the primary endpoint was at week 10. Global functioning was assessed by the Sheehan Disability Scale (SDS). Safety and tolerability was assessed by the occurrence of treatment-emergent adverse events, serious adverse events, laboratory analyses, and vital signs. Analyses were conducted on an intent-to-treat basis.
  
  
  RESULTS
  The overall baseline mean HAM-A total score was 24, and SDS global score was 14. Completion rates were 75% for placebo and 76% for duloxetine. At week 10, duloxetine was superior to placebo on mean changes from baseline in HAM-A total scores (-15.9 vs. -11.7, p < 0.001) and in SDS global scores (-8.6 vs. -5.4, p < 0.001). Treatment-emergent adverse events occurred in ≥5% of duloxetine-treated patients and twice the rate than with placebo including constipation (9% vs. 4%, p = 0.06), dry mouth (7% vs. 1%, p = 0.02), and somnolence (6% vs. 2%, p = 0.14).
  
  
  CONCLUSIONS
  Duloxetine treatment was efficacious in the improvement of anxiety and functioning in older adult patients with GAD, and the safety profile was consistent with previous GAD studies.
authors.affiliation: Eli Lilly and Company, Indianapolis, IN, USA.
authors.forename: Karla J
authors.initials: KJ
authors.lastname: Alaka
authors.forename: William
authors.initials: W
authors.lastname: Noble
authors.forename: Angel
authors.initials: A
authors.lastname: Montejo
authors.forename: Héctor
authors.initials: H
authors.lastname: Dueñas
authors.forename: Autar
authors.initials: A
authors.lastname: Munshi
authors.forename: Jeffrey R
authors.initials: JR
authors.lastname: Strawn
authors.forename: Alan
authors.initials: A
authors.lastname: Lenox-Smith
authors.forename: Jonna
authors.initials: J
authors.lastname: Ahl
authors.forename: Leszek
authors.initials: L
authors.lastname: Bidzan
authors.forename: Brita
authors.initials: B
authors.lastname: Dorn
authors.forename: Susan
authors.initials: S
authors.lastname: Ball
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000928:Antidepressive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001008:Anxiety Disorders / Q000188:drug therapy* / Q000523:psychology; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D000068736:Duloxetine Hydrochloride; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011569:Psychiatric Status Rating Scales; D017367:Selective Serotonin Reuptake Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D013876:Thiophenes / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D000928:Antidepressive Agents; D000068736:Duloxetine Hydrochloride; D017367:Selective Serotonin Reuptake Inhibitors; D013876:Thiophenes
keywords: anxiety; duloxetine; functioning