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A Prospective Trial of Modafinil as an Adjunctive Treatment of Major Depression

DeBattista, Charles MD; Lembke, Anna MD; Solvason, H. Brent MD, PhD; Ghebremichael, Rahwa BA; Poirier, Jennifer PhD

Journal of Clinical Psychopharmacology: February 2004 - Volume 24 - Issue 1 - p 87-90
doi: 10.1097/01.jcp.0000104910.75206.b9
Brief Reports

Abstract: Modafinil is a wake-promoting agent approved by the Federal Drug Administration for the treatment of narcolepsy. Preliminary evidence indicates that modafinil may improve fatigue and excessive sleepiness associated with a variety of conditions. The purpose of this study was to investigate the utility of modafinil as an adjunctive treatment of depressed patients. Subjects with a history of major depression with partial response on a stable therapeutic dose of an antidepressant were eligible to participate. All subjects endorsed complaints of significant fatigue and/or excessive sleepiness on clinical assessment. Modafinil was added to their existing regimen at a dose of 100 to 400 mg/d for 4 weeks. Subjects were assessed at 2-week intervals for improvement using the standard depression scales (HDRS, BDI, CGI), fatigue scales (VASF, FSI), and a neuropsychologic battery. Thirty-five subjects were entered and 31 subjects completed the 4-week trial. Significant improvements were seen across all 3 measures of depression (HDRS, BDI, CGIS) and both measures of fatigue (VASF, FSI). On the neurocognitive battery, significant gains in the Stroop Interference Test were seen at 4 weeks, whereas the other cognitive tests showed no change. Modafinil may be a useful and a well-tolerated adjunctive agent to standard antidepressants in the treatment of major depression.

Stanford University School of Medicine, Depression Research Clinic, 401 Quarry Road, Stanford, CA.

Received December 4, 2002; accepted after revision June 4, 2003.

Address correspondence and reprint requests to Charles DeBattista, MD, Stanford University School of Medicine, Depression Research Clinic, 401 Quarry Road, Stanford, CA 94305-5723. E-mail: debattista@stanford.edu.

© 2004 Lippincott Williams & Wilkins, Inc.