A Placebo-Controlled Evaluation of Adjunctive Modafinil in the Treatment of Bipolar Depression

• DOI: 10.1176/appi.ajp.2007.06060981
• Publication Date: 2007-08-01T21:33:50Z
• Authors: Mark A. Frye; Heinz Grunze; Trisha Suppes; Susan L. McElroy; Paul E. Keck; Jorge Walden; Gabriele S. Leverich; Lori L. Altshuler; Shoshanna Nakelsky; Sun Hwang; Jim Mintz; Robert M. Post
• Keywords: Hypomania; Adjunctive treatment; Depression

Objective: Modafinil is approved by the U.S. Food and Drug Administration for improving wakefulness in patients with excessive sleepiness associated narcolepsy, obstructive sleep apnea, shift-work disorder. This study was conducted to evaluate efficacy safety of adjunctive modafinil bipolar depression, which often characterized fatigue. Method: Eighty-five depression that inadequately responsive a mood stabilizer or without concomitant antidepressant therapy were randomly assigned receive (N=41) placebo (N=44) 6 weeks. The primary outcome measure baseline-to-endpoint change score on Inventory Depressive Symptoms—Clinician Rated (IDS). Results: IDS significantly greater group (mean dose, 177 mg/day) compared group. Improvement depressive symptoms week 2, this improvement maintained at weeks 4, 5, 6. Both response remission rates higher (44% 39%) (23% 18%). During 6-week period, there no difference between groups treatment-emergent hypomania mania (six five group) hospitalization (one each group). Conclusions: These data suggest doses 100–200 mg day may improve