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Original Article

A randomized, double-blind, placebo-controlled study of flexible doses of levomilnacipran ER (40–120 mg/day) in patients with major depressive disorder

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Pages 10-19 | Accepted 09 Jan 2014, Published online: 16 Jan 2014

References

  • Bromet E, Andrade LH, Hwang I, et al. Cross-national epidemiology of DSM-IV major depressive episode. BMC Med 2011;9:90
  • World Health Organization. The world health report 2004: Changing History. Annex Table 3: Burden of disease in DALYs by cause, sex, and mortality stratum in WHO regions, estimates for 2002. Geneva, Switzerland: World Health Organization, 2004. Available from: http://www.who.int/whr/2004/en/report04_en.pdf. [Last accessed 23 January 2014]
  • Rush AJ, Trivedi MH, Wisniewski SR, et al. Acute and longer-term outcomes in depressed outpatients requiring one or several treatment steps: a STAR*D report. Am J Psychiatry 2006;163:1905-17
  • Romera I, Perez V, Menchon JM, et al. Early switch strategy in patients with major depressive disorder: a double-blind, randomized study. J Clin Psychopharmacol 2012;32:479-86
  • Thase ME. Effectiveness of antidepressants: comparative remission rates. J Clin Psychiatry 2003;64(2 Suppl):3-7
  • Kelly K, Posternak M, Alpert JE. Toward achieving optimal response: understanding and managing antidepressant side effects. Dialogues Clin Neurosci 2008;10:409-18
  • Bull SA, Hu XH, Hunkeler EM, et al. Discontinuation of use and switching of antidepressants: influence of patient-physician communication. JAMA 2002;288:1403-9
  • Hu XH, Bull SA, Hunkeler EM, et al. Incidence and duration of side effects and those rated as bothersome with selective serotonin reuptake inhibitor treatment for depression: patient report versus physician estimate. J Clin Psychiatry 2004;65:959-65
  • Qaseem A, Snow V, Denberg TD, et al. Using second-generation antidepressants to treat depressive disorders: a clinical practice guideline from the American College of Physicians. Ann Intern Med 2008;149:725-33
  • Gueorguieva R, Mallinckrodt C, Krystal JH. Trajectories of depression severity in clinical trials of duloxetine: insights into antidepressant and placebo responses. Arch Gen Psychiatry 2011;68:1227-37
  • Guirguis-Blake J. Effectiveness of antidepressants compared with placebo for depression in primary care. Am Fam Physician 2010;82:42
  • Auclair AL, Martel JC, Assie MB, et al. Levomilnacipran (F2695), a norepinephrine-preferring SNRI: profile in vitro and in models of depression and anxiety. Neuropharmacology 2013;70:338-47
  • Deecher DC, Beyer CE, Johnston G, et al. Desvenlafaxine succinate: a new serotonin and norepinephrine reuptake inhibitor. J Pharmacol Exp Ther 2006;318:657-65
  • Montgomery S, Mansuy L, Ruth A, et al. Efficacy and safety of levomilnacipran sustained release in moderate to severe major depressive disorder: a randomized, double-blind, placebo-controlled, proof-of-concept study. J Clin Psychiatry 2013;74:363-9
  • Sambunaris A, Bose A, Gommoll C, et al. A Phase III, double-blind, placebo-controlled, flexible-dose study of levomilnacipran ER in patients with major depressive disorder. J Clin Psychopharmacol 2014;34:47-56
  • Asnis G, Bose A, Gommoll C, et al. The efficacy and safety of levomilnacipran SR 40 mg, 80 mg, or 120 mg in major depressive disorder: a phase III, randomized, double-blind, placebo-controlled study. J Clin Psychiatry 2013;74:242-8
  • Bakish D, Bose A, Gommoll C, et al. Levomilnacipran ER 40 mg and 80 mg in major depressive disorder: a phase III, randomized, double-blind, fixed-dose, placebo-controlled study. J Psychiatry Neurosci 2014;39:40-9
  • APA. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, 4th edn. Text Revision. Washington, DC: American Psychiatric Association, 2000
  • Sheehan DV, Lecrubier Y, Sheehan KH, et al. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry 1998;59(20 Suppl):22-33
  • Montgomery SA, Asberg M. A new depression scale designed to be sensitive to change. Br J Psychiatry 1979;134:382-9
  • Posner K, Brown GK, Stanley B, et al. The Columbia-Suicide Severity Rating Scale: initial validity and internal consistency findings from three multisite studies with adolescents and adults. Am J Psychiatry 2011;168:1266-77
  • Sheehan DV, Harnett-Sheehan K, Raj BA. The measurement of disability. Int Clin Psychopharmacol 1996;11(3 Suppl):89-95
  • Hamilton M. A rating scale for depression. J Neurol Neurosurg Psychiatry 1960;23:56-62
  • Guy W. ECDEU Assessment Manual for Psychopharmacology. “Clinical Global Impressions.” Rockville, MD: National Institute of Mental Health, p 218–22. DHEW Publication No. 76-338. 1976
  • McGahuey CA, Gelenberg AJ, Laukes CA, et al. The Arizona Sexual Experience Scale (ASEX): reliability and validity. J Sex Marital Ther 2000;26:25-40
  • Ware JE Jr. SF-36 health survey update. Spine (Phila Pa 1976) 2000;25:3130-9
  • Kenward MG, Molenberghs G, Thijs H. Pattern-mixture models with proper time dependence. Biometrika 2003;90:53-71
  • Watkins PB, Seligman PJ, Pears JS, et al. Using controlled clinical trials to learn more about acute drug-induced liver injury. Hepatology 2008;48:1680-9
  • Walsh BT, Seidman SN, Sysko R, et al. Placebo response in studies of major depression: variable, substantial, and growing. JAMA 2002;287:1840-7
  • Sonawalla SB, Rosenbaum JF. Placebo response in depression. Dialogues Clin Neurosci 2002;4:105-13
  • Rutherford BR, Roose SP. A model of placebo response in antidepressant clinical trials. Am j psychiatry 2013;170:723-33
  • Khan A, Khan S, Brown WA. Are placebo controls necessary to test new antidepressants and anxiolytics? Int J Neuropsychopharmacol 2002;5:193-7
  • Hooper M, Amsterdam J. Do clinical trials reflect drug potential? A review of FDA evaluation of new antidepressants. Poster Presented at the 39th Annual Meeting New Clinical Drug Evaluation Unit June 1–4; Boca Raton, FL, 1999
  • Bridge JA, Birmaher B, Iyengar S, et al. Placebo response in randomized controlled trials of antidepressants for pediatric major depressive disorder. Am J Psychiatry 2009;166:42-9
  • Khin NA, Chen YF, Yang Y, et al. Exploratory analyses of efficacy data from major depressive disorder trials submitted to the US Food and Drug Administration in support of new drug applications. J Clin Psychiatry 2011;72:464-72
  • Papakostas GI, Fava M. Does the probability of receiving placebo influence clinical trial outcome? A meta-regression of double-blind, randomized clinical trials in MDD. Eur Neuropsychopharmacol 2009;19:34-40
  • Khan A, Khan SR, Walens G, et al. Frequency of positive studies among fixed and flexible dose antidepressant clinical trials: an analysis of the food and drug administration summary basis of approval reports. Neuropsychopharmacology 2003;28:552-7
  • Khan A, Kolts RL, Thase ME, et al. Research design features and patient characteristics associated with the outcome of antidepressant clinical trials. Am J Psychiatry 2004;161:2045-9
  • Nemeroff CB. The burden of severe depression: a review of diagnostic challenges and treatment alternatives. J Psychiatr Res 2007;41:189-206
  • Khan A, Leventhal RM, Khan SR, et al. Severity of depression and response to antidepressants and placebo: an analysis of the Food and Drug Administration database. J Clin Psychopharmacol 2002;22:40-5
  • Kirsch I, Deacon BJ, Huedo-Medina TB, et al. Initial severity and antidepressant benefits: a meta-analysis of data submitted to the Food and Drug Administration. PLoS Med 2008;5:e45
  • Robinson DS, Rickels K. Concerns about clinical drug trials. J Clin Psychopharmacol 2000;20:593-6
  • Stahl SM, Grady MM, Moret C, et al. SNRIs: their pharmacology, clinical efficacy, and tolerability in comparison with other classes of antidepressants. CNS Spectr 2005;10:732-47
  • McGahuey CA, Delgado PL, Gelenberg AJ. Assessment of sexual dysfunction using the Arizona Sexual Experiences Scale (ASEX) and implications for the treatment of depression. Psychiat Ann 1999;29:39-45