What is the clinical evidence from this study?

Study design: RCT. Population: recurrent major depressive disorder (n=311). Intervention: Duloxetine vs. Placebo. Primary outcome: prespecified composite cognitive score composed of four individual tests.

What question did this study set out to answer?

This study aims to compare the effects of duloxetine versus placebo on cognition, depression, and pain in elderly patients with major depressive disorder.

June 1, 2007American Journal of Psychiatry

Efficacy of Duloxetine on Cognition, Depression, and Pain in Elderly Patients With Major Depressive Disorder: An 8-Week, Double-Blind, Placebo-Controlled Trial

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Key result

Duloxetine significantly improved the composite cognitive score compared with placebo (mean change 1.95 vs 0.76) in elderly patients with recurrent major depressive disorder.

Why the study?

Does duloxetine improve cognition, depression, and pain in elderly patients with recurrent major depressive disorder?

Population

311 elderly patients with recurrent major depressive disorder, median age 72 years (range 65-90)

Comparison

Duloxetine 60 mg/day for 8 weeks vs Placebo for 8 weeks

Design

RCT, Randomly assigned (2:1), Double-blind

Follow-up

8 weeks

Authors

JRJoel RaskinBioVentures (United States)CWCurtis G. WiltseUniversity of Wisconsin–Superior ASAlan P. SiegalYale University

Discussion

Member takes

Implication

Supports duloxetine for cognitive symptoms in elderly recurrent MDD; extends prior depression trials to cognition.

Key Points

This study aims to compare the effects of duloxetine versus placebo on cognition, depression, and pain in elderly patients with major depressive disorder.
Randomly assigned 311 elderly patients with major depressive disorder to receive duloxetine 60 mg/day or placebo for 8 weeks in a double-blind design.
Evaluated primary outcome through a composite cognitive score and secondary measures including depression and pain scales.
Duloxetine resulted in a greater improvement in the cognitive score (1.95 vs. 0.76) compared to placebo.
Significantly higher response (37.3% vs. 18.6%) and remission rates (27.4% vs. 14.7%) were observed for duloxetine on the Hamilton depression scale.
Duloxetine improved Visual Analogue Scale scores for pain, with fewer withdrawals due to lack of efficacy (2.9% vs. 9.6%) compared to placebo.

Study Design

Type

RCT (n=311)

Blinding

Double-blind

Randomization

2:1

Structured PICO

Does duloxetine improve cognition, depression, and pain in elderly patients with recurrent major depressive disorder?

Population

311 elderly patients (median age 72, range 65-90) with recurrent major depressive disorder, randomized 2:1 to duloxetine or placebo for 8 weeks.

Intervention

Duloxetine 60 mg/day for 8 weeks

Comparator

Placebo for 8 weeks

Outcome

Prespecified composite cognitive score composed of four individual testscomposite

Main Result

Absolute Event Rate: 1.95% vs 0.76%

Duloxetine 60 mg/day for 8 weeks significantly improved cognition, depression, and pain measures compared to placebo in elderly patients with recurrent major depressive disorder.

Cite This Study

Raskin et al. (2007) conducted an RCT in recurrent major depressive disorder (n=311). Duloxetine vs. Placebo was evaluated on prespecified composite cognitive score composed of four individual tests. Duloxetine significantly improved the composite cognitive score compared with placebo (mean change 1.95 vs 0.76) in elderly patients with recurrent major depressive disorder.

synapsesocial.com/papers/6a5b8ce8a816a06aba1244b3 https://doi.org/10.1176/ajp.2007.164.6.900

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Efficacy of Duloxetine on Cognition, Depression, and Pain in Elderly Patients With Major Depressive Disorder: An 8-Week, Double-Blind, Placebo-Controlled Trial

Discussion

Member takes

Implication

Key Points

Study Design

Structured PICO

Main Result

Cite This Study

Efficacy of Duloxetine on Cognition, Depression, and Pain in Elderly Patients With Major Depressive Disorder: An 8-Week, Double-Blind, Placebo-Controlled Trial

Discussion

Member takes

Implication

Key Points

Study Design

Structured PICO

Main Result

Cite This Study

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