International journal of geriatric psychiatryMar 20, 2014

Duloxetine’s safety and effectiveness for treating anxiety in older adults: a controlled clinical trial

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Updated Mar 28, 2026

Abstract

Duloxetine treatment resulted in a mean change from baseline in Hamilton Anxiety Rating Scale scores of -15.9 compared to -11.7 for placebo at week 10.

Older adults with generalized anxiety disorder (GAD) showed significant improvement in anxiety and functioning scores when treated with duloxetine compared to placebo.
Duloxetine was associated with greater reductions in both Hamilton Anxiety Rating Scale scores and Sheehan Disability Scale global scores.
Completion rates for the study were similar between the duloxetine (76%) and placebo (75%) groups.
Treatment-emergent adverse events occurred in 5% or more of patients taking duloxetine, with rates higher than those in the placebo group for certain side effects.
Commonly reported adverse events included constipation, dry mouth, and somnolence.

Simplified

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.

Key numbers

-15.9

Mean Change in HAM-A Score

Duloxetine vs. placebo at week 10

71.3%

Response Rate

Duloxetine vs. placebo

7.3%

Dry Mouth Incidence

Duloxetine vs. placebo (1.4%)

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Duloxetine’s safety and effectiveness for treating anxiety in older adults: a controlled clinical trial

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