title: A prospective trial of modafinil as an adjunctive treatment of major depression.
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.
authors.affiliation: Stanford University School of Medicine, Depression Research Clinic, Stanford, CA 94305-5723, USA. debattista@stanford.edu
authors.forename: Charles
authors.initials: C
authors.lastname: DeBattista
authors.forename: Anna
authors.initials: A
authors.lastname: Lembke
authors.forename: H Brent
authors.initials: HB
authors.lastname: Solvason
authors.forename: Rahwa
authors.initials: R
authors.lastname: Ghebremichael
authors.forename: Jennifer
authors.initials: J
authors.lastname: Poirier
mesh_terms: D000328:Adult; D000368:Aged; D000928:Antidepressive Agents / Q000494:pharmacology / Q000627:therapeutic use; D001559:Benzhydryl Compounds / Q000494:pharmacology / Q000627:therapeutic use*; D003865:Major Depressive Disorder / Q000175:diagnosis / Q000188:drug therapy*; D039721:Diagnostic and Statistical Manual of Mental Disorders; D006970:Disorders of Excessive Somnolence / Q000188:drug therapy; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D004361:Drug Tolerance; D005221:Fatigue / Q000188:drug therapy; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D000077408:Modafinil; D011446:Prospective Studies; D011569:Psychiatric Status Rating Scales; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000928:Antidepressive Agents; D001559:Benzhydryl Compounds; D000077408:Modafinil