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Duloxetine Treatment and Rate of Sexual Dysfunction in Patients With Depression: Presented at APA

SAN FRANCISCO -- May 26, 2009 -- Researchers found no significant difference between duloxetine and placebo in the incidence of treatment-emergent sexual dysfunction (TESD) in patients with major depressive disorder (MDD). The study was presented here at the 162nd Annual Meeting of the American Psychiatric Association (APA).

However, in patients not experiencing a recurrence of MDD, a significantly lower incidence of TESD was found in patients treated with duloxetine compared with placebo. The high rate of TESD with placebo suggests that depression itself is playing a major role.

Michael Detke, MD, Lilly Research Laboratories, Indianapolis, Indiana, and MedAvante, Hamilton, New Jersey, and colleagues evaluated the effects of long-term duloxetine treatment on the incidence of sexual dysfunction. "In acute treatment, what we have found is that a lot of patients have sexual dysfunction as part of their depression."

The study enrolled 514 patients. In the initial phase, patients received 60 to 120 mg of duloxetine per day for a maximum of 34 weeks. Those who were assessed to be responders to the therapy received additional maintenance treatment.

For the purposes of this study, among the initial response were a 17-item Hamilton Depression Rating Scale score of 9 and a Clinical Global Impressions - Severity score of 2.

Of those patients who underwent the initial phase of treatment, 288 were assessed to be responsive to the therapy. Patients were randomised to receive either a placebo or additional duloxetine therapy as part of the 52-week maintenance phase.

Endpoints for this phase of the study were evaluations using the Arizona Sexual Experience Scale as part of the overall assessment for TESD.

At baseline, the researchers assessed that 65% of study participants were experiencing sexual dysfunction. At the end of the first phase of therapy, the results demonstrated that 78% of those who did not respond to duloxetine and 58% of those who did respond still experienced sexual dysfunction.

Among patients who did not meet the criteria for sexual dysfunction at baseline, 43% of those who did not respond to duloxetine and 32% of those who did not respond, continued to experience TESD.

Among patients who continued in the maintenance phase, the researchers observed a nonsignificant difference (P = .08) in TESD rates between patients receiving placebo and those receiving duloxetine.

A significant difference was observed in TESD rates in patients with recurrent MDD receiving placebo (40%) and those receiving duloxetine (7%, P = .046).

Funding for this study was provided by Eli Lilly and Company and Boehringer Ingelheim GmbH.

[Presentation title: Course of Sexual Functioning During Long-Term Duloxetine Treatment in Patients With Recurrent Major Depressive Disorder. Abstract NR4-039]

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