Adjunct modafinil for the
short-term treatment of fatigue and sleepiness in patients with major depressive
disorder:
a preliminary double-blind, placebo-controlled study.
DeBattista C, Doghramji K,
Menza MA, Rosenthal MH, Fieve RR
Department of Psychiatry and Behavioral Sciences
Stanford University Medical Center
401 Quarry Road, Room 2137, Stanford, CA 94305.
debattista@leland.stanford.edu
J Clin Psychopharmacol. 2004 Feb; 24(1): 87-90
Abstract
BACKGROUND: Fatigue and sleepiness are
primary symptoms of depression that may not resolve with antidepressant therapy.
Modafinil is a novel agent that has been shown to improve wakefulness and lessen
fatigue in a variety of conditions. In this study, we examined the utility of
modafinil as an adjunct therapy to treat fatigue and sleepiness in patients with
major depression who are partial responders to antidepressants.
METHOD: Patients with partial response to anti-depressant therapy given for at
least a 6-week period for a current major depressive episode (DSM-IV criteria)
were enrolled in this 6-week, randomized, double-blind, placebo-controlled,
parallel-group, multicenter study. Patients received once-daily doses (100-400
mg) of modafinil or matching placebo as adjunct treatment to ongoing
antidepressant therapy. The effects of modafinil were evaluated using the
Hamilton Rating Scale for Depression (HAM-D), the Fatigue Severity Scale (FSS),
the Epworth Sleepiness Scale (ESS), the Clinical Global Impression of Change
(CGI-C), and the Medical Outcomes Study 36-Item Short-Form Health Survey
(SF-36). Adverse events were monitored throughout the study. RESULTS: One
hundred thirty-six patients were randomized to treatment, with 118 patients
(87%) completing the study. Most patients (82%) were fatigued, and one half of
patients (51%) were sleepy. Modafinil rapidly improved fatigue and daytime
wakefulness, with significantly greater mean improvements from baseline than
placebo in fatigue (FSS) scores at week 2 (p < .05) and sleepiness (ESS) scores
at week 1 (p < .01); the differences between modafinil and placebo at week 6
were not statistically significant. Assessment of the augmentation effects of
modafinil (HAM-D, CGI-C, and SF-36) did not significantly distinguish modafinil
from placebo. Modafinil was well tolerated in combination with a variety of
antidepressants.
CONCLUSION: Modafinil may be a useful adjunct therapy for the short-term
management of residual fatigue and sleepiness in patients who are partial
responders to antidepressant therapy.
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