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Title: Duloxetine (Cymbalta) Improves Depression and Cognition Measures in Depressed Elderly

"Duloxetine (Cymbalta) Improves Depression and Cognition Measures in Depressed Elderly"

By Bruce Sylvester ATLANTA, GA -- May 31, 2005 -- Duloxetine (Cymbalta) appears to be effective and well tolerated for improving both cognition and depression measures in elderly patients with major depressive disorder. Lead investigator Joel Raskin, MD, medical advisor at Eli Lilly and Company, Indianapolis, Indiana, United States, reported the findings here on May 25[^th at the American Psychiatric Association (APA) Annual Meeting.

"We saw significantly greater improvement in composite cognitive scoring for duloxetine, especially notable in memory and verbal learning skills," Dr. Raskin said. "This adds to our growing knowledge about the efficacy of Cymbalta, and particularly in relationship to the treatment of elderly patients, a growing and vulnerable population."

The investigators randomized 207 subjects to 8 weeks of duloxetine 60 mg once daily and 104 to placebo. They used a primary outcome measure of composite cognitive scoring based on five cognitive tests of verbal learning and memory, selective attention, and executive functioning. Secondary measures were Geriatric Depression Scale (GDS), 17-item Hamilton Depression Scale (HAMD17), Visual Analogue Scale (VAS) for pain, Clinical Global Impression - Severity Scale (CGI-Severity), and 36-item Short Form Survey (SF-36).

Duloxetine subjects had significantly greater improvement in cognitive composite scores versus placebo (P = .013), and significantly greater reductions in HAMD17 and GDS scores versus placebo.

"Duloxetine HAMD17 response and remission rates were approximately twice those of placebo," the authors noted.

Duloxetine subjects also showed greater improvement on CGI-severity, VAS for back pain, pain-while-awake and five of the SF-36 measures.

There was no significant difference in rates of discontinuation in the two study groups (9.7% duloxetine vs. 8.7% placebo), but more discontinuations for lack of efficacy in the placebo group (9.6% vs. 2.9%).

Adverse events included dry mouth, nausea, constipation, dizziness, diarrhea, fatigue, and somnolence, with rates of discontinuation-emergent adverse events being similar for duloxetine and placebo (14.2% vs. 10.0%).

"Duloxetine 60 mg QD produced rapid and significant improvement vs. placebo in GDS, HAMD17 and CGI-S, as well as some pain measures in elderly MDD [major depressive disorder] patients," the authors concluded. "Duloxetine was safe and well tolerated in elderly MDD patients."

The study was supported by Eli Lilly and Company.

[Presentation title: Duloxetine Versus Placebo in the Treatment of Elderly Patients With MDD. Abstract NR727]

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