Duloxetine hydrochloride, a dual reuptake inhibitor of serotonin and norepinephrine, was evaluated for its therapeutic efficacy, safety, and tolerability in the treatment of depression in patients with multiple sclerosis (MS). Lifetime depression prevalence approaches 50% in MS patients.
The aim of the study was to assess the safety and efficacy of duloxetine for treatment of depression in MS patients.
An open-label study evaluated the efficacy of 12 weeks of duloxetine administration (maximal dose = 60 mg/d) in MS patients with clinical depression. The Beck scale score variation after 4 (T1) and 12 (T2) weeks of treatment was used for the primary outcome measurement, whereas secondary outcome was measured using the Modified Fatigue Impact Scale. Safety was evaluated by recording treatment-related adverse events, monitoring vital signs, and recording frequency and reasons for interruption or discontinuation of treatment.
Seventy-five patients were enrolled in the study. Sixty-three patients completed the study by continuing duloxetine treatment for 12 weeks (T2). Twelve subjects dropped out of the study because of adverse effects or noncompliance. Nausea was the most common adverse event reported. A significant reduction in the Beck Depression Inventory and Modified Fatigue Impact Scale scores, after both 4 and 12 weeks of therapy, was observed.
The results suggest that duloxetine is well tolerated, safe, and effective in reducing depression and fatigue in MS patients.