Efficacy and tolerability of duloxetine treatment in elderly patients with major depressive disorder and concurrent anxiety symptoms.
OBJECTIVE
To compare the efficacy and tolerability of duloxetine 60mg/day versus placebo in treating elderly patients with major depressive disorder (MDD) and concurrent anxiety symptoms.


METHODS
Patients (>/=65) were randomized to eight weeks of treatment with duloxetine 60mg/day (n=207) or placebo (n=104). Anxiety measures were analyzed for all patients, by age (<75 and >/=75), and in patients having concurrent high anxiety (HAMD(17), item 10; Psychic Anxiety baseline score of 2, 3, or 4). Psychic Anxiety, Somatic Anxiety item 11, and the Anxiety/Somatization subscale were analyzed for all patients and subgroups by mean change from baseline to endpoint and repeated measures. Tolerability was assessed via treatment-emergent adverse events (TEAEs), and adverse events were reported as the reason for discontinuation. The analyses presented are primarily post hoc in nature.


RESULTS
Duloxetine produced significantly greater reductions than placebo in Psychic Anxiety (least-squares mean change: -0.62 vs. -0.18, p<0.001) and the Anxiety/Somatization subscale (-1.88 vs. -0.99, p=0.002). Repeated measures analyses showed separation between the treatment groups beginning at Week 1 for Psychic Anxiety and Week 4 for the Anxiety/Somatization subscale. Significant improvement occurred in the <75 and >/=75 age groups for Psychic Anxiety, but only the <75 group for the Anxiety/Somatization subscale. Duloxetine-treated patients with high anxiety showed significant improvement compared with placebo-treated patients on Psychic Anxiety, Anxiety/Somatization subscale, the 17-item Hamilton Depression Rating Scale (HAMD(17)) total score, and several other measures. Duloxetine and placebo had similar TEAE rates and discontinuation rates due to adverse events.


CONCLUSIONS
Duloxetine (60mg/day) was efficacious and tolerable in elderly patients with MDD and concurrent anxiety symptoms.
Russell
James
J
Raskin
Joel
J
Wiltse
Curtis
C
Walker
Daniel
D
Brawman-Mintzer
Olga
O