The antidepressant duloxetine, at a once-daily dose of 60 mg, significantly reduced non-specific pain and emotional symptoms associated with depression in a new, eight-week, placebo-controlled study of 327 adult patients with at least moderate pain and major depression. The results were presented today at the 15th European Congress of Psychiatry (AEP) in Madrid, Spain.
Duloxetine, a member of a class of drugs commonly referred to as serotonin and norepinephrine reuptake inhibitors (SNRIs), is approved in more than 70 countries for the treatment of major depression.
?Whereas traditionally, the focus has been on treating only emotional symptoms of depression, we now know that the presence of physical symptoms, specifically pain, can obscure the diagnosis and complicate the management of patients,? said Professor Koen Demyttenaere, Department of Psychiatry at University Hospital Gasthuisberg in Belgium and lead study investigator. ?In this study of depressed patients with at least moderate pain, duloxetine helped by significantly reducing both painful and emotional symptoms of depression, and in decreasing the interference of pain with functioning.?
In the study:
Average pain scores, the primary outcome measured, decreased significantly among patients treated with duloxetine by 45 percent (on an 11-point Likert scale from 5.7 at baseline to 3.13 at the final visit in Week 8) compared with a decrease of 29 percent (from 5.7 to 4.06) among those taking placebo (p< 0.001).Duloxetine significantly reduced core emotional symptoms, as assessed by the Montgomery-Asberg Depression Rating Scale (MADRS), by 56 percent (from an average score of 29.6 at baseline to 12.91 at Week 8), compared with a 39-percent reduction (from 29.6 to 18.29) in patients taking placebo (p<0.0001).53 percent of duloxetine-treated patients reached remission (MADRS <12) by the end of the study, compared with 29 percent of placebo-treated patients (p< 0.0001).Compared with placebo, duloxetine-treated patients also experienced a significantly better outcome in response to pain (>30% reduction from baseline in average pain severity) and improved daily functioning not limited by pain (BPI interference subscale).
10.5 percent of study patients treated with duloxetine and 5.5 percent of patients treated with placebo discontinued treatment because of adverse events. The most commonly reported adverse events among those taking duloxetine were nausea (24.7 percent for duloxetine-treated patients, vs. 7.9 percent for those taking placebo), excessive sweating (11.7 percent vs. 2.4 percent), dry mouth (10.5 percent vs. 3.6 percent), headache (7.4 percent vs. 9.1 percent), fatigue (8.0 percent vs. 1.8 percent), dizziness (5.6 percent vs. 3.6 percent), and constipation (5.6 percent vs. 1.2 percent).