OBJECTIVE: Management of depression in elderly patients presents a significant medical challenge, and there is a need for further clinical trials. The authors examined the efficacy and tolerability of escitalopram and fluoxetine versus placebo in the treatment of elderly patients with major depressive disorder (MDD). METHODS: This was an 8-week, randomized, double-blind comparison of the efficacy and tolerability of escitalopram (10 mg/day) and fluoxetine (20 mg/day), to placebo in elderly patients with MDD. The prospectively defined primary efficacy parameter was the change from baseline in mean Montgomery-Asberg Depression Rating Scale (MADRS) total score at endpoint, using last observation carried forward. RESULTS: The intent-to-treat set comprised 517 patients; the escitalopram group included 173 patients; fluoxetine, 164 patients; and placebo, 180 patients. Mean age was 75 years, with a range of 65 to 93. Formally, this was a "failed study" (i.e., neither active treatment was superior to placebo), and the efficacy results should, therefore, be interpreted with caution. On the basis of the primary efficacy parameter, fluoxetine showed significantly lower efficacy than both escitalopram and placebo, which were not significantly different from each other. Rates of withdrawal because of adverse events/lack of efficacy were: placebo (2.8%/4.4%, respectively), escitalopram (9.8%/1.7%, respectively), and fluoxetine (12.2%/1.8%, respectively). No single adverse event occurred at an incidence > or =10% in escitalopram-treated patients. CONCLUSIONS: Both escitalopram and fluoxetine were well tolerated by elderly patients with MDD. Neither demonstrated superior efficacy on primary endpoint versus placebo.
RCT Entities:
OBJECTIVE: Management of depression in elderly patients presents a significant medical challenge, and there is a need for further clinical trials. The authors examined the efficacy and tolerability of escitalopram and fluoxetine versus placebo in the treatment of elderly patients with major depressive disorder (MDD). METHODS: This was an 8-week, randomized, double-blind comparison of the efficacy and tolerability of escitalopram (10 mg/day) and fluoxetine (20 mg/day), to placebo in elderly patients with MDD. The prospectively defined primary efficacy parameter was the change from baseline in mean Montgomery-Asberg Depression Rating Scale (MADRS) total score at endpoint, using last observation carried forward. RESULTS: The intent-to-treat set comprised 517 patients; the escitalopram group included 173 patients; fluoxetine, 164 patients; and placebo, 180 patients. Mean age was 75 years, with a range of 65 to 93. Formally, this was a "failed study" (i.e., neither active treatment was superior to placebo), and the efficacy results should, therefore, be interpreted with caution. On the basis of the primary efficacy parameter, fluoxetine showed significantly lower efficacy than both escitalopram and placebo, which were not significantly different from each other. Rates of withdrawal because of adverse events/lack of efficacy were: placebo (2.8%/4.4%, respectively), escitalopram (9.8%/1.7%, respectively), and fluoxetine (12.2%/1.8%, respectively). No single adverse event occurred at an incidence > or =10% in escitalopram-treated patients. CONCLUSIONS: Both escitalopram and fluoxetine were well tolerated by elderly patients with MDD. Neither demonstrated superior efficacy on primary endpoint versus placebo.
Authors: Bret R Rutherford; Jane Tandler; Patrick J Brown; Joel R Sneed; Steven P Roose Journal: Am J Geriatr Psychiatry Date: 2013-11-05 Impact factor: 4.105
Authors: Winfried Rief; Yvonne Nestoriuc; Anna von Lilienfeld-Toal; Imis Dogan; Franziska Schreiber; Stefan G Hofmann; Arthur J Barsky; Jerry Avorn Journal: Drug Saf Date: 2009 Impact factor: 5.606
Authors: Glenda M MacQueen; Benicio N Frey; Zahinoor Ismail; Natalia Jaworska; Meir Steiner; Ryan J Van Lieshout; Sidney H Kennedy; Raymond W Lam; Roumen V Milev; Sagar V Parikh; Arun V Ravindran Journal: Can J Psychiatry Date: 2016-08-02 Impact factor: 4.356
Authors: Benoit H Mulsant; Daniel M Blumberger; Zahinoor Ismail; Kiran Rabheru; Mark J Rapoport Journal: Clin Geriatr Med Date: 2014-06-14 Impact factor: 3.076