A double-blind, placebo-controlled study of armodafinil for excessive sleepiness in patients with treated obstructive sleep apnea and comorbid depression

Journal of Clinical Psychiatry

Volumn 71, Issue 1, 2010, Pages 32-40

  Krystal, Andrew D ^a   Harsh, John R ^b   Yang, Ronghua R ^c   Rippon, Gregory A ^c   Lankford, D Alan ^d  

^a DUKE UNIVERSITY MEDICAL CENTER   (United States)

^b UNIVERSITY OF SOUTHERN MISSISSIPPI   (United States)

^c CEPHALON INC   (United States)

^d Sleep Disorders Center of Georgia   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARMODAFINIL; CITALOPRAM; DULOXETINE; ESCITALOPRAM; FLUOXETINE; PAROXETINE; PLACEBO; SERTRALINE; VENLAFAXINE; ANTIDEPRESSANT AGENT; BENZHYDRYL DERIVATIVE; CENTRAL STIMULANT AGENT; MODAFINIL;

ADULT; AGED; AGGRESSION; AGITATION; AIRWAY PRESSURE; ANXIETY DISORDER; ARTICLE; CLINICAL TRIAL; COMORBIDITY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIAGNOSTIC AND STATISTICAL MANUAL OF MENTAL DISORDERS; DOUBLE BLIND PROCEDURE; DRUG DOSE INCREASE; DRUG DOSE REDUCTION; DRUG DOSE TITRATION; DRUG TOLERABILITY; DYSTHYMIA; FEMALE; HALLUCINATION; HAMILTON SCALE; HEADACHE; HUMAN; HYPOMANIA; INSOMNIA; INTERNATIONAL CLASSIFICATION OF DISEASES; MAJOR DEPRESSION; MALE; NAUSEA; NERVOUSNESS; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RESTLESSNESS; SELF REPORT; SIDE EFFECT; SLEEP; SLEEP APNEA SYNDROME; SLEEP DISORDER; SOMNOLENCE; SUICIDAL IDEATION; TREATMENT OUTCOME; XEROSTOMIA; MIDDLE AGED; MULTICENTER STUDY; POSITIVE END EXPIRATORY PRESSURE; PSYCHOLOGICAL RATING SCALE;

ANTIDEPRESSIVE AGENTS; BENZHYDRYL COMPOUNDS; CENTRAL NERVOUS SYSTEM STIMULANTS; CONTINUOUS POSITIVE AIRWAY PRESSURE; DEPRESSIVE DISORDER, MAJOR; DISORDERS OF EXCESSIVE SOMNOLENCE; DOUBLE-BLIND METHOD; DYSTHYMIC DISORDER; FEMALE; HUMANS; MALE; MIDDLE AGED; PSYCHIATRIC STATUS RATING SCALES; SLEEP APNEA SYNDROMES;

EID: 77449125950     PISSN: 01606689     EISSN: None     Source Type: Journal    
DOI: 10.4088/JCP.09m05536gry     Document Type: Article

References (42)

1. American Academy of Sleep Medicine. International Classification of Sleep Disorders: Diagnostic and Coding Manual. 2nd ed. Westchester, IL: American Academy of Sleep Medicine; 2005.
2. Patel SR, White DP, Malhotra A, et al. Continuous positive airway pressure therapy for treating sleepiness in a diverse population with obstructive sleep apnea: results of a meta-analysis. Arch Intern Med. 2003;163(5):565-571.
3. Giles TL, Lasserson TJ, Smith BJ, et al. Continuous positive airways pressure for obstructive sleep apnoea in adults. Cochrane Database Syst Rev. 2006;(1)CD001106.
4. Weaver TE, Maislin G, Dinges DF, et al. Relationship between hours of CPAP use and achieving normal levels of sleepiness and daily functioning. Sleep. 2007;30(6):711-719.
5. Saunamäki T, Jehkonen M. Depression and anxiety in obstructive sleep apnea syndrome: a review. Acta Neurol Scand. 2007;116(5):277-288.
6. Carney RM, Howells WB, Freedland KE, et al. Depression and obstructive sleep apnea in patients with coronary heart disease. Psychosom Med. 2006;68(3):443-448.
7. Cross RL, Kumar R, Macey PM, et al. Neural alterations and depressive symptoms in obstructive sleep apnea patients. Sleep. 2008;31(8):1103- 1109.
8. Bardwell WA, Ancoli-Israel S, Dimsdale JE. Comparison of the effects of depressive symptoms and apnea severity on fatigue in patients with obstructive sleep apnea: a replication study. J Affect Disord. 2007;97(1-3):181-186.
9. Yue W, Hao W, Liu P, et al. A case-control study on psychological symptoms in sleep apnea-hypopnea syndrome. Can J Psychiatry. 2003;48(5):318-323.
10. Sforza E, de Saint Hilaire Z, Pelissolo A, et al. Personality, anxiety and mood traits in patients with sleep-related breathing disorders: effect of reduced daytime alertness. Sleep Med. 2002;3(2):139-145.
11. Fava M. Daytime sleepiness and insomnia as correlates of depression. J Clin Psychiatry. 2004;65(suppl 16):27-32.
12. Chen Y, Kelton CM, Jing Y, et al. Utilization, price, and spending trends for antidepressants in the US Medicaid Program. Res Social Adm Pharm. 2008;4(3):244-257.
13. Pirraglia PA, Stafford RS, Singer DE. Trends in prescribing of selective serotonin reuptake inhibitors and other newer antidepressant agents in adult primary care. Prim Care Companion J Clin Psychiatry. 2003;5(4):153-157.
14. Beasley CM Jr, Koke SC, Nilsson ME, et al. Adverse events and treatment discontinuations in clinical trials of fluoxetine in major depressive disorder: an updated meta-analysis. Clin Ther. 2000;22(11):1319-1330.
15. Bull SA, Hunkeler EM, Lee JY, et al. Discontinuing or switching selective serotonin-reuptake inhibitors. Ann Pharmacother. 2002;36(4):578-584.
16. Danjou P, Hackett D. Safety and tolerance profile of venlafaxine. Int Clin Psychopharmacol. 1995;10(suppl 2):15-20.
17. Papakostas GI, Homberger CH, Fava M. A meta-analysis of clinical trials comparing mirtazapine with selective serotonin reuptake inhibitors for the treatment of major depressive disorder. J Psychopharmacol. 2008;22(8):843-848.
18. Rutledge T, Reis VA, Linke SE, et al. Depression in heart failure a metaanalytic review of prevalence, intervention effects, and associations with clinical outcomes. J Am Coll Cardiol. 2006;48(8):1527-1537.
19. van Melle JP, de Jonge P, Spijkerman TA, et al. Prognostic association of depression following myocardial infarction with mortality and cardiovascular events: a meta-analysis. Psychosom Med. 2004;66(6):814-822.
20. Robertson P Jr, Hellriegel ET. Clinical pharmacokinetic profile of modafinil. Clin Pharmacokinet. 2003;42(2):123-137.
21. Hirshkowitz M, Black JE, Wesnes K, et al. Adjunct armodafinil improves wakefulness and memory in obstructive sleep apnea/hypopnea syndrome. Respir Med. 2007;101(3):616-627.
22. Roth T, White D, Schmidt-Nowara W, et al. Effects of armodafinil in the treatment of residual excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome: a 12-week, multicenter, double-blind, randomized, placebo-controlled study in nCPAP-adherent adults. Clin Ther. 2006;28(5):689-706.
23. Roth T, Czeisler CA, Walsh JK, et al. Randomized, double-blind, placebo-controlled study of armodafinil for the treatment of excessive sleepiness associated with chronic shift work sleep disorder [abstract]. Neuropsychopharmacology. 2005;30:S140.
24. Harsh JR, Hayduk R, Rosenberg R, et al. The efficacy and safety of armodafinil as treatment for adults with excessive sleepiness associated with narcolepsy. Curr Med Res Opin. 2006;22(4):761-774.
25. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) adopts consolidated guideline on good clinical practice in the conduct of clinical trials on medicinal products for human use. Int Dig Health Legis. 1997;48(2):231-234.
26. Dickel MJ, Mosko SS. Morbidity cut-offs for sleep apnea and periodic leg movements in predicting subjective complaints in seniors. Sleep. 1990;13(2):155-166.
27. Kushida CA, Morgenthaler TI, Littner MR, et al; American Academy of Sleep. Practice parameters for the treatment of snoring and obstructive sleep apnea with oral appliances: an update for 2005. Sleep. 2006;29(2):240-243.
28. Lavie P. Incidence of sleep apnea in a presumably healthy working population: a significant relationship with excessive daytime sleepiness. Sleep. 1983;6(4):312-318.
29. Zammit G, Erman M, Wang-Weigand S, et al. Evaluation of the efficacy and safety of ramelteon in subjects with chronic insomnia. J Clin Sleep Med. 2007;3(5):495-504.
30. Kribbs NB, Pack AI, Kline LR, et al. Objective measurement of patterns of nasal CPAP use by patients with obstructive sleep apnea. Am Rev Respir Dis. 1993;147(4):887-895.
31. Guy W. ECDEU Assessment Manual for Psychopharmacology. US Department of Health, Education and Welfare publication (ADM) 76-338. Rockville, MD: National Institute of Mental Health, 1976:218-222.
32. Johns MW. A new method for measuring daytime sleepiness: the Epworth Sleepiness Scale. Sleep. 1991;14(6):540-545.
33. Hamilton M. A rating scale for depression. J Neurol Neurosurg Psychiatry. 1960;23:56-62.
34. Sheehan DV, Lecrubier Y, Janavs J, et al. Mini-International Neuropsychiatric Interview (MINI). Tampa, FL: University of South Florida, Institute for Research in Psychiatry, and Paris, France: INSERM-Hôpital de la Salpêtrière; 1994.
35. Poceta JS, Timms RM, Jeong DU, et al. Maintenance of Wakefulness Test in obstructive sleep apnea syndrome. Chest. 1992;101(4):893-897.
36. Walsleben JA, Kapur VK, Newman AB, et al. Sleep and reported daytime sleepiness in normal subjects: the Sleep Heart Health Study. Sleep. 2004;27(2):293-298.
37. Rush AJ, Trivedi MH, Ibrahim HM, et al. The 16-Item Quick Inventory of Depressive Symptomatology (QIDS), clinician rating (QIDS-C), and self-report (QIDS-SR): a psychometric evaluation in patients with chronic major depression. Biol Psychiatry. 2003;54(5):573-583.
38. Benjamini Y, Hochberg Y. Controlling the false discovery rate: a practical and powerful approach to multiple testing. J R Stat Soc B. 1995;57:289-300.
39. Walsh BT, Seidman SN, Sysko R, et al. Placebo response in studies of major depression: variable, substantial, and growing. JAMA. 2002;287(14):1840-1847.
40. DeBattista C, Doghramji K, Menza MA, et al; Modafinil in Depression Study Group. Adjunct modafinil for the short-term treatment of fatigue and sleepiness in patients with major depressive disorder: a preliminary double-blind, placebo-controlled study. J Clin Psychiatry. 2003;64(9):1057-1064.
41. Dunlop BW, Crits-Christoph P, Evans DL, et al. Coadministration of modafinil and a selective serotonin reuptake inhibitor from the initiation of treatment of major depressive disorder with fatigue and sleepiness: a double-blind, placebo-controlled study. J Clin Psychopharmacol. 2007;27(6):614-619.
42. Fava M, Thase ME, DeBattista C. A multicenter, placebo-controlled study of modafinil augmentation in partial responders to selective serotonin reuptake inhibitors with persistent fatigue and sleepiness. J Clin Psychiatry. 2005;66(1):85-93.