The objective of this paper is to better understand the relationship of
pain and mood in patients with
fibromyalgia and comorbid
major depressive disorder (MDD). Pooled data from 4 double-blind, placebo-controlled, randomized trials of
duloxetine hydrochloride 60-120mg/day in patients with
fibromyalgia were included (N=1332). Of these, 350 (26% [147 placebo, 203
duloxetine]) had comorbid MDD (per Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Text Revision criteria) and were included in these analyses. Primary measures included Brief
Pain Inventory average
pain; Hamilton Depression Rating Scale or Beck Depression Inventory. Logistic regression was used to evaluate the consistency of treatment effect across various subgroups. Path analysis was used to assess the effect of
duloxetine on improvement in
pain in the presence of improvement in mood and vice versa. Results indicated that 69% of improvement in
pain was a direct effect of treatment, with improvement in mood accounting for 31% of
pain response. In conclusion, consistent with our hypothesis,
duloxetine produced a substantial direct effect on
pain improvement and change in mood exerted a modest indirect effect on
pain improvements in patients with
fibromyalgia and MDD. Hence, both direct and indirect
analgesic and
antidepressant properties appear to be relevant for the treatment of these comorbid patients with
duloxetine.