Efficacy of agomelatine in more anxious elderly depressed patients. A randomized, double-blind study vs placebo.
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Agomelatine, has been shown to be effective and well-tolerated, in treating: major depressive disorder, anxiety symptoms of depression (1,2) and Generalized Anxiety Disorder (3,4). The present analysis evaluate the antidepressant efficacy of agomelatine in the more anxious elderly depressed patients >= 65 years, based on a score of the HAMD combined items 10 and 11 >= 5 at baseline. In this 8-week international double-blind randomized study, among 222 elderly depressed out-patients randomized, 119 were more anxious: 82 in the agomelatine 25-50 mg group and 37 in the placebo group. In the total population, the mean HAM-D total score significantly decreased from baseline to endpoint with agomelatine vs placebo, p=0.013. In the more anxious population, the decrease on the mean HAM-D total score was also significantly higher with agomelatine (from 27.8 alpha 3.0 to 12.2 alpha 7.9) vs placebo (from 28.1 alpha 3.3 to 16.3 alpha 8.8) with a difference in favor of agomelatine of 4.14 (SE=1.57), p=0.010. The response rate (on HAM-D) was higher on agomelatine (68.3%) than on placebo (40.5%), p=0.004. On the three SDS scores, patients reported significantly less symptom-related impairments on agomelatine than on placebo on work/daily activities (p=0.001), in social life (p=0.020), and in family life (p=0.010). In these patients, most common reported adverse events and more frequent on agomelatine were somnolence, headache, nausea, diarrhoea, upper respiratory tract infection and pain in extremity. There was no transaminases increase. This results show that agomelatine is efficacious in the treatment of more anxious elderly depressed patients.