Objective: Long-term treatment of major depressive disorder in an older population presents many concerns. This report describes the efficacy and safety of duloxetine, a dual reuptake inhibitor of serotonin and norepinephrine, in the treatment of MDD in elderly (age >65) patients, and provides comparisons with results obtained in younger (age <65)patients.
Design: Data were obtained from a 52-week, open-label study in which patients with MDD (age <65: n=1178; age >/=65: n=101) received duloxetine treatment (80 mg/d to 120 mg/d).
Materials and Methods: Efficacy measures included the Clinical Global Impression of Severity (CGI-S) scale, Hamilton Rating Scale for Depression (HAMD17) total score, Beck Depression Inventory-II (BDI-II), Patient Global Impression of Improvement (PGI-I) scale, and the Sheehan Disability Scale (SDS).
Results: Significant improvement (p<.001) in both clinician- (CGI-S) and patient-rated (PGI-I) measures of improvement were observed at Week 1 and sustained throughout the study in both elderly and younger patients. Mean changes in CGI-S total score were significantly greater for younger patients (age <65) at Weeks 2, 3, and 4 of treatment, compared with patients aged >65. At all subsequent visits, no significant differences existed between age groups. Among the treatment-emergent, adverse events most commonly reported, rates of insomnia, and headache were significantly lower for elderly patients compared with the younger group (insomnia: 21.8% vs. 32.1%, p=.034; headache: 15.8% vs. 31.7%, p<.001). No adverse event occurred significantly more frequently in the older age group.
Conclusion: In this study, the safety and efficacy of duloxetine for the long-term treatment of MDD were found to be comparable in elderly and younger patients.
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