Source: Haematologica  |  Posted 6 years ago

By Steve Pridgeon

VANCOUVER, CANADA -- November 10, 2005 -- Elderly patients who are treated with duloxetine experienced improved cognition and reduced symptoms of depression, according to research presented at the 55[^]th[] annual conference of the Canadian Psychiatric Association (CPA).

Significant improvement was also seen in some pain measures compared to placebo, said senior investigator Joel Raskin, MD, Medical Advisor, Eli Lilly and Company, Indianapolis, Indiana, United States.

According to Dr. Raskin, elderly patients with major depressive disorder (MDD) often have cognitive impairment. Duloxetine is a dual inhibitor that acts on both norepinephrine and 5-HT receptors. These systems are known to contribute to cognitive deficits, making duloxetine a good candidate for use in elderly patients.

Investigators conducted a multicenter, double-blind, placebo-controlled study with 311 patients, who were randomised 2:1 to either duloxetine or placebo. The trial continued for 8 weeks, followed by a 1-week, double-blind discontinuation phase.

The primary outcome measure was a composite cognitive score based on tests of verbal learning and memory, selective attention and executive function. Secondary measures included the Geriatric Depression Scale (GDS), 17-item Hamilton Depression Scale (HAMD[_]17[]), Visual Analogue Scale (VAS) for pain, Clinical Global Impression - Severity Scale (CGI-S), and 36-item Short Form Survey (SF-36).

Patients on duloxetine demonstrated greater improvement in the cognitive tests than those on placebo (P = .013). Response and remission rates as measured by HAMD17 were approximately twice those of placebo. VAS scores showed that duloxetine was superior to placebo for back pain and time in pain while awake. Pain reductions were significant at week 1 and were maintained through the study period.

"Significantly more placebo than duloxetine patients discontinued owing to lack of efficacy [9.6% vs. 2.9%]," the authors said.

Adverse event rates were similar in the placebo and treatment groups. No elevation of blood pressure was seen in study subjects.

The investigators concluded that duloxetine improved cognitive functions, reduced depression and some measures of pain, and was safe and well tolerated in elderly patients with major depressive disorder.

This presentation was funded by Lilly Research Laboratories.

[Presentation title: Duloxetine versus Placebo in the Treatment of Elderly Patients With Major Depressive Disorder. Abstract P-17]