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| |  Armodafinil Improves Excessive Sleepiness Associated With Treated Obstructive Sleep Apnoea in Patients With Depression: Presented at ENS By Chris Berrie MILAN, Italy -- June 25, 2009 -- Armodafinil is generally well tolerated and significantly improves overall clinical conditions in patients with residual excessive sleepiness associated with continuous positive airway pressure (CPAP)-treated obstructive sleep apnoea (OSA) who have a comorbid major depressive disorder (MDD) or dysthymic disorder requiring antidepressant monotherapy, according to researchers here at the 19th Meeting of the European Neurological Society (ENS). Andrew Krystal, MD, Department of Psychiatry and Sleep Disorders Center, Duke University Medical Center, Durham, North Carolina, presented the multicentre, randomised, double-blind, placebo-controlled, parallel-group study on June 23 . The study included 249 patients aged 18 to 65 years with OSA and residual excessive sleepiness even with adherence to CPAP therapy. Diagnosis of MDD or dysthymic disorder with ongoing antidepressant treatment was also specified. Patients were randomised to placebo (n = 124) or armodafinil (n = 125) as a single morning dose over 12 weeks. Armodafinil started at 50 mg/day and increased by 50-mg increments (days 2, 5, and 8) to 200 mg/day. The proportion of patients with at least minimal improvement in Clinical Global Impression of Severity of Illness score was significantly greater for armodafinil (69%) than for placebo (53%; P = .012). Improvement was seen for armodafinil over placebo in the Maintenance of Wakefulness Test, but the difference was not significant (2.6 vs 1.1 minutes; P = .30). In addition, significant benefits for armodafinil over placebo were seen for Epworth Sleepiness Scale score (-6.3 vs -4.8; P = .0027) and Functional Outcomes of Sleep Questionnaire score (+2.2 vs +1.7; P = .0308). A beneficial trend for armodafinil was seen in the Brief Fatigue Inventory score (-8.3 vs -4.4; P = .0523). The incidence of adverse events was similar for the treatment groups, and, although insomnia was more common among patients receiving armodafinil (7% vs 2% for placebo), nighttime sleep was comparable. Both treatment groups saw mildly reduced depressive symptoms, and no adverse events occurred relating to suicidal ideation, mania, or hypomania. "It does appear to be possible to treat cases of daytime sleepiness of patients with OSA who are treated with CPAP and who are taking selective serotonin reuptake inhibitors," said Dr. Krystal. Funding for this study was provided by Cephalon Inc. [Presentation title: A Randomised, Double-Blind, Placebo-Controlled Study With Armodafinil in Patients With Residual Excessive Sleepiness Associated With CPAP-Treated Obstructive Sleep Apnoea and Comorbid Depressive Disorders. Abstract P353]
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