Adjunct Modafinil for Fatigue and Wakefulness in Major Depressive Disorder

In this study, patients with partial response to antidepressants given for at least six weeks prior were enrolled in this six-week, randomized, double-blind, placebo-controlled, multicenter study. Patients received modafinil (100 mg/day to 400 mg/day) or placebo as adjunct treatment to ongoing antidepressant therapy. Changes in fatigue and daytime sleepiness were evaluated using the Fatigue Severity Scale (FSS) and Epworth Sleepiness Scale (ESS), and adverse events were recorded.

Of 136 patients randomized, 118 (87%) completed this study. Most patients were fatigued (82%) and half (51%) were sleepy. Modafinil rapidly improved fatigue and daytime wakefulness, with significantly greater mean changes from baseline than placebo in FSS scores at week 2 (p<0.05) and in ESS scores at week 1 (p<0.01). Modafinil was generally tolerated. These results indicate that modafinil may be a useful adjunct for the management of fatigue and sleepiness in patients who are partial responders to antidepressant therapy. Ref: Psychiatric Times