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Clinical Trial
. 2014 Sep;29(9):978-86.
doi: 10.1002/gps.4088. Epub 2014 Feb 20.

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

Karla J Alaka  1 , William Noble, Angel Montejo, Héctor Dueñas, Autar Munshi, Jeffrey R Strawn, Alan Lenox-Smith, Jonna Ahl, Leszek Bidzan, Brita Dorn, Susan Ball
Affiliations
Free PMC article
Clinical Trial

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

Karla J Alaka et al. Int J Geriatr Psychiatry. 2014 Sep.
Free PMC article

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).

Conclusion: 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.

Keywords: anxiety; duloxetine; functioning.

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Figures

Figure 1
Figure 1
Consort diagram of recruitment and patient flow through the study.
Figure 2
Figure 2
Least squares mean change from baseline to endpoint in HAM-A total score (MMRM analysis).
Figure 3
Figure 3
Least squares mean change from baseline to endpoint on the Sheehan Disability Scale items and Global Functioning Impairment scores (MMRM analysis).
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