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dc.contributor.authorHeun, Reinhard
dc.identifier.citationEuropean Neuropsychopharmacology. 2014; 24: S403-S404.language
dc.description.abstractWith an increasingly ageing population, there is a growing need to develop novel ways to treat depression in the elderly. Few published placebo-controlled study results in elderly depressed patients reached a clinical difference of at least 2 points vs placebo on the HAM-D total score, while no positive trial in patients older than 75 years has been published yet [1-3]. The present analysis assesses the 24-week antidepressant efficacy and safety of agomelatine 25-50 mg versus placebo in elderly out-patients suffering from moderate to severe Major Depressive Disorder (MDD). Agomelatine being indicated in patients aged less than 75 years, results in this sub-population are presented. In this phase III, international, randomized, double-blind trial, 222 patients aged of at least 65 years were randomized to receive agomelatine 25-50 mg (n = 151) or placebo (n = 71). Among the 146 patients who entered the 18-week double-blind extension period (109 on agomelatine and 37 on placebo), 116 completed the 24 week treatment period (88 on agomelatine and 28 on placebo). In the FAS (N = 218), the mean HAM-D17 total score significantly decreased from baseline to endpoint with agomelatine (from 26.9+2.8 to 12.3+8.9) vs placebo (from 26.8+3.2 to 15.3+8.9) with a significant difference in favor of agomelatine of 2.90 (SE = 1.20), p = 0.017. In the more severe patients (HAM-D17 total score >25 and CGI-S >5 at baseline), the clinical benefit was reinforced with a significant difference in favor of agomelatine of 3.67 (SE = 1.57), p = 0.022. In patients <75 years (N = 149), the observed difference vs placebo was 3.57 (1.51), p = 0.019. The response rate to treatment (decrease in HAM-D17 total score from baseline of at least 50%) was significantly higher with agomelatine than with placebo: 61% vs 43% respectively in the FAS (p = 0.013), 69% vs 49% respectively in the more severe patients (p = 0.024) and 63% vs 41% in patients <75 years (p = 0.010). More patients were remitters (HAM-D17 total score <7) with agomelatine than with placebo 34% vs 23% respectively in the FAS (NS), 38% vs 24% respectively in the more severe patients (NS) and 40% vs 22% in patients <75 years, p = 0.034. In terms of functional outcome there was a significant improvement in the agomelatine group as compared to placebo with a difference on the SDS total score of: 3.23 (1.15), p = 0.006 in the FAS, 3.43 (1.42), p = 0.021 in the more severe patients and 3.53 (1.42), p = 0.015 in patients <75 years. The most frequent emergent adverse events (in at least 5% of patients) were: somnolence (6.6%), headache (6.0%) and diarrhea (5.3%) on agomelatine, nasopharyngitis (7.0%), headache, dizziness and fatigue (5.6% each) on placebo. Two patients in agomelatine group (1 aged >75 years) with normal liver enzyme values at baseline had potentially clinically significant transaminases increase (>3ULN). All values normalized after agomelatine discontinuation. These results demonstrate the long-term antidepressant efficacy of agomelatine combined with a good tolerability profile and social functioning benefits in elderly MDD patients over 24 weekslanguage
dc.subjectDepressive Disorderlanguage
dc.subjectDrug Therapylanguage
dc.subjectGeriatric Psychiatrylanguage
dc.titleSustained efficacy and safety of agomelatine versus placebo over 24 weeks in elderly out-patients suffering from major depressive disorderlanguage

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