Efficacy and safety of duloxetine in the treatment of older adult patients with generalized anxiety disorder: a randomized, double-blind, placebo-controlled trial.

摘要: Objective This was a flexible-dosed study to evaluate the efficacy and safety of duloxetine 30–120 mg once daily in treatment generalized anxiety disorder (GAD) older adult patients. Methods Patients with GAD, who were at least 65 years age, randomly assigned double-blind either (N = 151) or placebo (N = 140). The primary measure Hamilton Anxiety Rating Scale (HAM-A) total score, endpoint week 10. Global functioning assessed by Sheehan Disability (SDS). Safety tolerability occurrence treatment-emergent adverse events, serious laboratory analyses, vital signs. Analyses conducted on an intent-to-treat basis. Results The overall baseline mean HAM-A score 24, SDS global 14. Completion rates 75% for 76% duloxetine. At 10, superior changes from scores (−15.9 vs. −11.7, p < 0.001) (−8.6 −5.4, p < 0.001). Treatment-emergent events occurred ≥5% duloxetine-treated patients twice rate than including constipation (9% 4%, p = 0.06), dry mouth (7% 1%, p = 0.02), somnolence (6% 2%, p = 0.14). Conclusion Duloxetine efficacious improvement profile consistent previous GAD studies. © 2014 Authors. International Journal Geriatric Psychiatry published John Wiley & Sons, Ltd.