Painful physical symptoms (PPS) in major depressive disorder (MDD) can obscure the diagnosis and impair treatment outcome. Antidepressants inhibiting serotonin and norepinephrine reuptake (SNRI) can be effective in the treatment of both emotional and PPS in MDD. This study evaluated efficacy and safety of duloxetine, an SNRI, in the treatment of patients with moderate pain associated with depression.

In this double-blind, placebo-controlled, European, 8-week study, outpatients ≥18 years of age, presenting with major depression (Montgomery-Asberg Depression Rating Scale [MADRS] ≥20 and Clinical Global Impression-Severity [CGI-S] ≥4) and moderate pain (brief pain inventory [BPI] average pain score ≥3) not attributable to a diagnosed pain syndrome were randomized to either placebo (N=165) or duloxetine 60mg (N=162) once daily. Primary outcome measure was the BPI average pain score at endpoint. Secondary measures were MADRS total score, CGI-S, PGI-I, SCL-90 R, response and remission in MDD, safety, and tolerability.

Duloxetine compared with placebo significantly (P <.001) improved the mean change of both BPI average pain (-2.57 vs. -1.64) and MADRS total scores (-16.69 vs. -11.31) with significant separation after 1 or 2 weeks. Remission in MDD (53% vs. 29%) and response rates in pain and MDD were significantly higher in duloxetine-treated patients. Duloxetine separated on most secondary outcome measures from placebo. Treatment-emergent adverse events (≥10%) observed in duloxetine- treated patients were nausea, hyperhydrosis, and dry mouth.

These results support duloxetine's efficacy and tolerability in the treatment of PPS and emotional symptoms in patients with moderate pain associated with depression.