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Duloxetine May Prevent Relapses in Adults With Generalised Anxiety Disorder: Presented at ADAA

By Mike Fillon

SAVANNAH, Ga -- March 10, 2008 -- A new study shows that once-daily doses of duloxetine 60 to 120 mg may prevent relapses in adults with generalised anxiety disorder (GAD), according to a study presented here at the Anxiety Disorders Association of America (ADAA) 28th Annual Conference.

According to the ADAA, GAD is characterised by persistent, excessive, and unrealistic worry about everyday things. This worry occurs on more days than not for at least 6 months. ADAA estimates there are 6.8 million people with GAD, and women are twice as likely to be affected as men.

This new study initially included 887 patients with a mean age of 43.3 years and diagnosed with GAD according to the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision. Patients entered open-label treatment with duloxetine 60 to 120 mg for 26 weeks followed by a 26-week double-blind treatment. The initial cohort was 61% female.

Treatment response was defined as at least a 50% improvement in the total score to a score of at least 11 on the Hamilton Anxiety Rating Scale, and a clinician improvement rating of "much improved" or "very much improved" for the last two visits of open-label treatment. Patients who completed open-label treatment and met this definition were randomly assigned to receive duloxetine (n = 216) or placebo (n = 213) for the 26-week double-blind continuation phase.

Mean age of those who completed the study was 45 years in the duloxetine group and 46 years in the placebo group.

The primary outcome measure was percent of patients who relapsed, defined as either a 2-point or greater increase from double-blind randomisation in Clinical Global Impressions-Severity rating to a score of 4 or greater, or discontinuation due to lack of efficacy. Role functioning and quality of life were assessed using the Sheehan Disability Scale and the Quality of Life Enjoyment and Satisfaction Questionnaire (Short-Form), respectively.

During the double-blind continuation phase, 41.8% of placebo-treated patients relapsed compared with 13.7% of duloxetine-treated patients (P <= .001). On secondary efficacy and functioning measures, placebo-treated patients significantly worsened compared with duloxetine-treated patients (P <= .001, each comparison). Rates of discontinuation due to adverse events were 13.6% during the open-label phase and 1.9% in the double-blind continuation phase for duloxetine-treated patients.

Common adverse effects after the open label phase were nausea (28.3%), headache (18.7%), dry mouth (14.3%), diarrhoea (14.2%), and dizziness (13.4%). After the double-blind phase, 3.7% of those taking duloxetine complained of dizziness compared with 9.9% of those taking placebo. Headaches were reported by 5.6% in the duloxetine group and 5.2% of the placebo group. Also, 6.6% of the placebo group reported anxiety compared with 2.8% of the duloxetine group.

"We found duloxetine 60 to 120 mg once-daily treatment was efficacious [and] associated with significantly lower relapse rates than placebo," said Susan G. Ball, Research Scientist, Lilly Research Laboratories, Indianapolis, Indiana, in a presentation on March 7th. "We also found a greater maintenance of quality of life and daily functioning, and it was generally well tolerated during this 1-year study."

Funding for this study was provided by Eli Lilly and Company and Boehringer Ingelheim GmbH.


[Presentation title: Duloxetine 60 to 120 mg Once Daily Treatment for the Prevention of Relapse in Adults With Generalized Anxiety Disorder. Abstract 17]

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