Efficacy of duloxetine on cognition, depression, and pain in elderly patients with major depressive disorder: An 8-week, double-blind, placebo-controlled trial

Joel Raskin, Curtis G. Wiltse, Alan Siegal, Javaid Sheikh, Jimmy Xu, James J. Dinkel, Benjamin T. Rotz, Richard C. Mohs

Research output: Contribution to journalArticle

232 Citations (Scopus)

Abstract

Objective: This study compared the effects of duloxetine, 60 mg/day, versus placebo on cognition, depression, and pain in elderly patients with recurrent major depressive disorder. Method: Patients were randomly assigned (2:1) to duloxetine, 60 mg/day (N=207), or placebo (N=104) for 8 weeks in a double-blind study. The primary outcome measure was a prespecified composite cognitive score composed of four individual tests. Secondary measures included the Geriatric Depression Scale, the Hamilton Depression Rating Scale, the Visual Analogue Scale assessing pain, and standard safety and tolerability assessments. Results: Patients had a median age of 72 years (range=65-90). Duloxetine demonstrated significantly greater improvement in the composite cognitive score versus placebo (least-squares mean change from baseline to endpoint: 1.95 versus 0.76), driven by improved verbal learning and memory. Duloxetine treatment showed significantly greater baseline-to-endpoint reductions in both Hamilton depression scale (-6.49 versus -3.72) and Geriatric Depression Scale (-4.07 versus-1.34) total scores compared with placebo. Hamilton depression scale response (37.3% versus 18.6%) and remission (27.4% versus 14.7%) rates at endpoint were significantly higher for duloxetine than for placebo. Duloxetine significantly improved Visual Analogue Scale scores for back pain and time in pain while awake versus placebo. Significantly fewer patients receiving duloxetine withdrew from the study because of lack of efficacy (2.9% versus 9.6%); the incidences of discontinuation due to adverse events were similar for duloxetine and placebo (9.7% versus 8.7%). Conclusions: Duloxetine improved cognition, depression, and some pain measures and was safe and well tolerated in elderly patients with recurrent major depressive disorder.

Original languageEnglish
Pages (from-to)900-909
Number of pages10
JournalAmerican Journal of Psychiatry
Volume164
Issue number6
DOIs
Publication statusPublished - Jun 2007

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Major Depressive Disorder
Cognition
Placebos
Depression
Pain
Geriatrics
Duloxetine Hydrochloride
Verbal Learning
Pain Measurement
Back Pain
Least-Squares Analysis
Visual Analog Scale
Double-Blind Method
Outcome Assessment (Health Care)
Safety
Incidence

ASJC Scopus subject areas

  • Psychiatry and Mental health

Cite this

Efficacy of duloxetine on cognition, depression, and pain in elderly patients with major depressive disorder : An 8-week, double-blind, placebo-controlled trial. / Raskin, Joel; Wiltse, Curtis G.; Siegal, Alan; Sheikh, Javaid; Xu, Jimmy; Dinkel, James J.; Rotz, Benjamin T.; Mohs, Richard C.

In: American Journal of Psychiatry, Vol. 164, No. 6, 06.2007, p. 900-909.

Research output: Contribution to journalArticle

Raskin, Joel ; Wiltse, Curtis G. ; Siegal, Alan ; Sheikh, Javaid ; Xu, Jimmy ; Dinkel, James J. ; Rotz, Benjamin T. ; Mohs, Richard C. / Efficacy of duloxetine on cognition, depression, and pain in elderly patients with major depressive disorder : An 8-week, double-blind, placebo-controlled trial. In: American Journal of Psychiatry. 2007 ; Vol. 164, No. 6. pp. 900-909.
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abstract = "Objective: This study compared the effects of duloxetine, 60 mg/day, versus placebo on cognition, depression, and pain in elderly patients with recurrent major depressive disorder. Method: Patients were randomly assigned (2:1) to duloxetine, 60 mg/day (N=207), or placebo (N=104) for 8 weeks in a double-blind study. The primary outcome measure was a prespecified composite cognitive score composed of four individual tests. Secondary measures included the Geriatric Depression Scale, the Hamilton Depression Rating Scale, the Visual Analogue Scale assessing pain, and standard safety and tolerability assessments. Results: Patients had a median age of 72 years (range=65-90). Duloxetine demonstrated significantly greater improvement in the composite cognitive score versus placebo (least-squares mean change from baseline to endpoint: 1.95 versus 0.76), driven by improved verbal learning and memory. Duloxetine treatment showed significantly greater baseline-to-endpoint reductions in both Hamilton depression scale (-6.49 versus -3.72) and Geriatric Depression Scale (-4.07 versus-1.34) total scores compared with placebo. Hamilton depression scale response (37.3{\%} versus 18.6{\%}) and remission (27.4{\%} versus 14.7{\%}) rates at endpoint were significantly higher for duloxetine than for placebo. Duloxetine significantly improved Visual Analogue Scale scores for back pain and time in pain while awake versus placebo. Significantly fewer patients receiving duloxetine withdrew from the study because of lack of efficacy (2.9{\%} versus 9.6{\%}); the incidences of discontinuation due to adverse events were similar for duloxetine and placebo (9.7{\%} versus 8.7{\%}). Conclusions: Duloxetine improved cognition, depression, and some pain measures and was safe and well tolerated in elderly patients with recurrent major depressive disorder.",
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