Adjunctive armodafinil for major depressive episodes associated with bipolar I disorder: A randomized, multicenter, double-blind, placebo-controlled, proof-of-concept study

Journal of Clinical Psychiatry

Volumn 71, Issue 10, 2010, Pages 1363-1370

  Calabrese, Joseph R ^a   Ketter, Terence A ^b   Youakim, James M ^c   Tiller, Jane M ^c   Yang, Ronghua ^c   Frye, Mark A ^d  

^a CASE WESTERN RESERVE UNIVERSITY   (United States)

^b STANFORD UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c CEPHALON INC   (United States)

^d MAYO CLINIC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARMODAFINIL; LITHIUM; OLANZAPINE; PLACEBO; VALPROIC ACID;

ADD ON THERAPY; ADULT; ANXIETY; ARTICLE; BIPOLAR DEPRESSION; BIPOLAR I DISORDER; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DEPRESSION; DIARRHEA; DOUBLE BLIND PROCEDURE; DRUG DOSE INCREASE; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG WITHDRAWAL; FEMALE; HUMAN; HYPOMANIA; INSOMNIA; MAJOR CLINICAL STUDY; MAJOR DEPRESSION; MALE; MANIA; MORNING DOSAGE; MULTICENTER STUDY; NAUSEA; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RESTLESSNESS; SIDE EFFECT; SOMNOLENCE; UPPER RESPIRATORY TRACT INFECTION; URTICARIA; WEIGHT GAIN; XEROSTOMIA;

ADOLESCENT; ADULT; AGED; ANTIDEPRESSIVE AGENTS; ANTIMANIC AGENTS; BENZHYDRYL COMPOUNDS; BENZODIAZEPINES; BIPOLAR DISORDER; DEPRESSIVE DISORDER, MAJOR; DOUBLE-BLIND METHOD; DRUG RESISTANCE; DRUG THERAPY, COMBINATION; FEMALE; HUMANS; LITHIUM COMPOUNDS; MALE; MIDDLE AGED; VALPROIC ACID;

EID: 78149321657     PISSN: 01606689     EISSN: None     Source Type: Journal    
DOI: 10.4088/JCP.09m05900gry     Document Type: Article

References (35)

1. Judd LL, Schettler PJ, Solomon DA, et al. Psychosocial disability and work role function compared across the long-term course of bipolar I, bipolar II and unipolar major depressive disorders. J Affect Disord. 2008;108(1-2):49-58. doi:10.1016/j.jad.207.06.014 PubMed
2. Weissman MM, Bland RC, Canino GJ, et al. Cross-national epidemiology of major depression and bipolar disorder. JAMA. 1996;276(4):293-299. doi:10.101/jama.276.4.293 PubMed
3. Merikangas KR, Akiskal HS, Angst J, et al. Lifetime and 12-month prevalence of bipolar spectrum disorder in the National Comorbidity Survey Replication. Arch Gen Psychiatry. 2007;64(5):543-552. doi:10.101/archpsyc.64.5. 543 PubMed
4. Akiskal HS, Akiskal KK, Lancrenon S, et al. Validating the bipolar spectrum in the French National EPIDEP Study: overview of the phenomenology and relative prevalence of its clinical prototypes. J Affect Disord. 2006;96(3):197-205. doi:10.1016/j.jad.206.05.015 PubMed
5. Judd LL, Akiskal HS, Schettler PJ, et al. The long-term natural history of the weekly symptomatic status of bipolar I disorder. Arch Gen Psychiatry. 2002;59(6):530-537. doi:10.101/archpsyc.59.6.530 PubMed
6. Kupka RW, Altshuler LL, Nolen WA, et al. Three times more days depressed than manic or hypomanic in both bipolar I and bipolar II disorder. Bipolar Disord. 2007;9(5):531-535. doi:10.1/j.139-5618.207.0467.x PubMed
7. Goodwin FK, Jamison KR. Suicide. In: Manic-Depressive Illness: Bipolar Disorders and Recurrent Depression. 2nd ed. New York, NY: Oxford University Press; 2007:247-272.
8. Allison DB, Newcomer JW, Dunn AL, et al. Obesity among those with mental disorders: a National Institute of Mental Health meeting report. Am J Prev Med. 2009;36(4):341-350. doi:10.1016/j.amepre.208.1.020 PubMed
9. Miller BJ, Paschall CB 3rd, Svendsen DP. Mortality and medical comorbidity among patients with serious mental illness. Psychiatr Serv. 2006;57(10):1482-1487. doi:10.176/api.ps.57.10.1482 PubMed
10. Post RM, Denicoff KD, Leverich GS, et al. Morbidity in 258 bipolar outpatients followed for 1 year with daily prospective ratings on the NIMH Life Chart Method. J Clin Psychiatry. 2003;64(6):680-690, quiz 738-739. doi:10.408/JCP.v64n0610 PubMed
11. Tondo L, Isacsson G, Baldessarini R. Suicidal behaviour in bipolar disorder: risk and prevention. CNS Drugs. 2003;17(7):491-511. doi:10.2165/023210-20317070-03 PubMed (Pubitemid 36693704)
12. Frye MA, Grunze H, Suppes T, et al. A placebo-controlled evaluation of adjunctive modafinil in the treatment of bipolar depression. Am J Psychiatry. 2007;164(8):1242-1249. doi:10.176/api.ajp.207.06060981 PubMed
13. 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. doi:10.1016/j.rmed.206.06.07 PubMed
14. 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. doi:10.1016/j.clinthera.206.05.013 PubMed
15. Czeisler CA, Walsh JK, Wesnes KA, et al. Armodafinil for treatment of excessive sleepiness associated with shift work disorder: a randomized controlled study. Mayo Clin Proc. 2009;84(11):958-972. doi:10.4065/84.1.958 PubMed
16. 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. doi:10.185/0307906X1050 PubMed
17. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Harmonised Tripartite Guideline: Guideline for Good Clinical Practice, E6(R1). Current Step 4 version. 10 June 1996. http://www.ich.org/LOB/media/ MEDIA482.pdf. Accessed November 20, 2009.
18. First MB, Spitzer RL, Gibbon M, et al. Structured Clinical Interview for DSM-IV-TR Axis I Disorders. New York, NY: Biometrics Research, New York State Psychiatric Institute; 2002.
19. 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. doi:10.1016/S06-323(02)0186-8 PubMed
20. Spearing MK, Post RM, Leverich GS, et al. Modification of the Clinical Global Impressions (CGI) scale for use in bipolar illness (BP): the CGI-BP. Psychiatry Res. 1997;73(3):159-171. doi:10.1016/S0165-1781(97)0123-6 PubMed
21. Young RC, Biggs JT, Ziegler VE, et al. A rating scale for mania: reliability, validity and sensitivity. Br J Psychiatry. 1978;133(5):429-435. doi:10.192/bjp.13.5.429 PubMed
22. Hamilton M. The assessment of anxiety states by rating. Br J Med Psychol. 1959;32(1):50-55. PubMed
23. Åsberg M, Montgomery SA, Perris C, et al. A comprehensive psychopathological rating scale. Acta Psychiatr Scand suppl. 1978;57(271):5-27. doi:10.1/j.160-047.1978.tb02357.x
24. Rush AJ, Gullion CM, Basco MR, et al. The Inventory of Depressive Symptomatology (IDS): psychometric properties. Psychol Med. 1996;26(3):477-486. doi:10.1017/S0329170358 PubMed
25. Oquendo MA, Halberstam B, Mann JJ. Risk factors for suicidal behavior: the utility and limitations of research instruments. In: First MB, ed. Standardized Assessment for the Clinician. Washington, DC: American Psychiatric Publishing; 2003:103-130.
26. Endicott J, Nee J, Harrison W, et al. Quality of Life Enjoyment and Satisfaction Questionnaire: a new measure. Psychopharmacol Bull. 1993;29(2):321-326. PubMed
27. Posner K, Melvin GA, Stanley B, et al. Factors in the assessment of suicidality in youth. CNS Spectr. 2007;12(2):156-162. PubMed
28. Müller MJ, Himmerich H, Kienzle B, et al. Differentiating moderate and severe depression using the Montgomery-Åsberg Depression Rating Scale (MADRS). J Affect Disord. 2003;77(3):255-260. doi:10.1016/S0165-0327(02)0120-9 PubMed
29. Tohen M, Vieta E, Calabrese J, et al. Efficacy of olanzapine and olanzapine- fluoxetine combination in the treatment of bipolar I depression. Arch Gen Psychiatry. 2003;60(11):1079-1088. doi:10.101/archpsyc.60.1.1079 PubMed
30. Calabrese JR, Keck PE Jr, Macfadden W, et al. A randomized, double-blind, placebo-controlled trial of quetiapine in the treatment of bipolar I or II depression. Am J Psychiatry. 2005;162(7):1351-1360. doi:10.176/api.ajp.162.7. 1351 PubMed
31. Thase ME, Macfadden W, Weisler RH, et al; BOLDER II Study Group. Efficacy of quetiapine monotherapy in bipolar I and II depression: a double-blind, placebo-controlled study (the BOLDER II Study). J Clin Psychopharmacol. 2006;26(6):600-609. doi:10.1097/01.jcp.0248603.76231.b7 PubMed
32. Perlis RH. Treatment of bipolar disorder: the evolving role of atypical antipsychotics. Am J Manag Care. 2007;13(suppl):S178-S188. PubMed
33. Goodwin GM; Consensus Group of the British Association for Psychopharmacology. Evidence-based guidelines for treating bipolar disorder: revised second edition - recommendations from the British Association for Psychopharmacology. J Psychopharmacol. 2009;23(4): 346-388. doi:10.17/ 02698109102919 PubMed
34. Sachs GS, Nierenberg AA, Calabrese JR, et al. Effectiveness of adjunctive antidepressant treatment for bipolar depression. N Engl J Med. 2007;356(17):1711-1722. doi:10.1056/NEJMoa064135 PubMed
35. van der Loos ML, Mulder PG, Hartong EG, et al, for the LamLit Study Group. Efficacy and safety of lamotrigine as add-on treatment to lithium in bipolar depression: a multicenter, double-blind, placebo-controlled trial. J Clin Psychiatry. 2009;70(2):223-231. doi:10.408/JCP.08m04152 PubMed