An open-label clinical trial of milnacipran in fibromyalgia syndrome with co-morbid depressive symptoms.

OBJECTIVE

To evaluate the efficacy of the serotonin and noradrenaline reuptake inhibiting antidepressant, milnacipran, in patients with fibromyalgia syndrome and co-morbid depression.

METHODS

Twenty patients with fibromyalgia syndrome and co-morbid depressive symptoms were treated with the serotonin and noradrenaline reuptake inhibitor, milnacipran, in an open label study. The initial dose of milnacipran was 30 mg/day which could be increased as needed up to 100 mg/day. Patients were evaluated at baseline and after 4, 8 and 12 weeks of treatment. Pain level and global symptomatology were determined using visual analogue scales. Pain was also accessed by use of the face scale, while the severity of depression was determined using the Zung self-rating depression scale.

RESULTS

Two patients withdrew because of persistent nausea. Pain and general symptomatology were significantly improved at the end of the study, with five patients having a reduction in pain of greater than 50%. Post-hoc analysis showed that the 11 patients who were no longer depressed at the end of the study had the greatest improvement in pain and overall FMS symptomatology.

CONCLUSIONS

The data suggest that milnacipran may be effective in the treatment of FMS, especially when associated with depression. Qnt] Psych Clin Pract 2004; 8: 47-51).