A randomized, double-blind, duloxetine-referenced study comparing efficacy and tolerability of 2 fixed doses of vortioxetine in the acute treatment of adults with MDD

Psychopharmacology

Volumn 232, Issue 12, 2015, Pages 2061-2070

  Mahableshwarkar, Atul R ^a   Jacobsen, Paula L ^a   Chen, Yinzhong ^a   Serenko, Michael ^a   Trivedi, Madhukar H ^b  

^a TAKEDA DEVELOPMENT CENTER AMERICAS   (United States)

^b UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER   (United States)

Author keywords

Antidepressant; ASEX; MDD; Multimodal; Treatment emergent sexual dysfunction

Indexed keywords

DULOXETINE; PLACEBO; VORTIOXETINE; ANTIDEPRESSANT AGENT; PIPERAZINE DERIVATIVE; SEROTONIN UPTAKE INHIBITOR; SULFIDE;

ACUTE DRUG ADMINISTRATION; ADULT; AGED; ARIZONA SEXUAL EXPERIENCES SCALE; ARTICLE; CLINICAL ASSESSMENT TOOL; COLUMBIA SUICIDE SEVERITY RATING SCALE; CONSTIPATION; CONTROLLED STUDY; DIARRHEA; DISCONTINUATION EMERGENT SIGNS AND SYMPTOMS CHECKLIST; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; ELECTROCARDIOGRAPHY; FATIGUE; FEMALE; HEADACHE; HUMAN; INSOMNIA; LABORATORY TEST; MAJOR CLINICAL STUDY; MAJOR DEPRESSION; MALE; MONTGOMERY ASBERG DEPRESSION RATING SCALE; MULTICENTER STUDY; NAUSEA; PARALLEL DESIGN; PHYSICAL EXAMINATION; PRIORITY JOURNAL; PSYCHOLOGICAL RATING SCALE; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; SCORING SYSTEM; SEXUAL DYSFUNCTION; SUICIDAL BEHAVIOR; SUICIDAL IDEATION; TREATMENT DURATION; TREATMENT RESPONSE; UPPER RESPIRATORY TRACT INFECTION; VITAL SIGN; VOMITING; XEROSTOMIA; ADOLESCENT; COMPARATIVE STUDY; COMPLICATION; DEPRESSIVE DISORDER, MAJOR; DOSE RESPONSE; DRUG EFFECTS; MIDDLE AGED; PSYCHOLOGY; YOUNG ADULT;

ADOLESCENT; ADULT; AGED; ANTIDEPRESSIVE AGENTS; DEPRESSIVE DISORDER, MAJOR; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; DULOXETINE HYDROCHLORIDE; ELECTROCARDIOGRAPHY; FATIGUE; FEMALE; HUMANS; MALE; MIDDLE AGED; PIPERAZINES; PSYCHIATRIC STATUS RATING SCALES; SEROTONIN UPTAKE INHIBITORS; SLEEP INITIATION AND MAINTENANCE DISORDERS; SUICIDAL IDEATION; SULFIDES; YOUNG ADULT;

EID: 84929358849     PISSN: 00333158     EISSN: 14322072     Source Type: Journal    
DOI: 10.1007/s00213-014-3839-0     Document Type: Article

References (29)

1. Alvarez E, Perez V, Dragheim M, Loft H, Artigas F (2012) A double-blind, randomized, placebo-controlled, active reference study of Lu AA21004 in patients with major depressive disorder. Int J Neuropsychopharmacol 15:589-600
2. Baldwin DS, Hansen T, Florea I (2012a) Vortioxetine (Lu AA21004) in the long-term open-label treatment of major depressive disorder. Curr Med Res Opin 28:1717-1724
3. Baldwin DS, Loft H, Dragheim M (2012b) A randomised, double-blind, placebo controlled, duloxetine-referenced, fixed-dose study of three dosages of Lu AA21004 in acute treatment of major depressive disorder (MDD). Eur Neuropsychopharmacol 22:482-491
4. Bang-Andersen B, Ruhland T, Jørgensen M, Smith G, Frederiksen K, Jensen KG, Zhnog H, Nielsen SM, Hogg S, Mørk A, Stensbøl TB (2011) Discovery of 1-[2-(2,4-dimethylphenylsulfanyl)phenyl]piperazine (Lu AA21004): a novel multimodal compound for the treatment of major depressive disorder. J Med Chem 54:3206-3221
5. Boulenger JP, Loft H, Florea I (2012) A randomized clinical study of Lu AA21004 in the prevention of relapse in patients with major depressive disorder. J Psychopharmacol 26:1408-1416
6. Boulenger JP, Loft H, Olsen CK (2014) Efficacy and safety of vortioxetine (Lu AA21004), 15 and 20 mg/day: a randomised, double-blind, placebo-controlled, duloxetine-referenced study in the acute treatment of adult patients with major depressive disorder. Int Clin Psyhcopharmacol 29:138-149
7. Bridge JA, Birmaher B, Iyengar S, Barbe RP et al (2009) Placebo response in randomized controlled trials of antidepressants for pediatric major depressive disorder. Am J Psychiatr 166:42-49
8. Brunoni AR, Lopes M, Kaptchuk TJ, Fregni F (2009) Placebo response of non-pharmacological and pharmacological trials in major depression: a systematic review and meta-analysis. PLoS One 4:e4824
9. Delgado PL, Brannan SK, Mallinckrodt CH, Tran PV, McNamara RK, Watkin JG, Detke MJ (2005) Sexual functioning assessed in 4 double-blind placebo- and paroxetine-controlled trials of duloxetine for major depressive disorder. J Clin Psychiatr 66:686-692
10. Guy W (1976) Clinical global impressions (028-CGI). Revised ed. Rockville, MD: U.S. Dept. of Health, Education, and Welfare, Public Health Service, Alcohol, Drug Abuse, and Mental Health Administration, National Institute of Mental Health, Psychopharmacology Research Branch, Division of Extramural Research Programs; 217-222.
11. Hamilton M (1959) The assessment of anxiety states by rating. Br J Med Psychol 32:50-55
12. Henigsberg N, Mahableshwarkar AR, Jacobsen P, Chen Y, Thase ME (2012) A randomized, double-blind, placebo-controlled 8-week trial of the efficacy and tolerability of multiple doses of Lu AA21004 in adults with major depressive disorder. J Clin Psychiatr 73:953-959
13. Jacobsen P, Mahableshwarkar AR, Serenko M, Chan S, Trivedi M (2013) A randomized, double-blind, placebo-controlled study of the efficacy and safety of vortioxetine 10 mg and 20 mg in adults with major depressive disorder [abstract]. American Psychiatric Association (APA) 166th Annual Meeting 2013 (manuscript submitted for publication J Clin Psych)
14. Jain R, Mahableshwarkar A, Jacobson P, Chen Y, Thase ME (2013) A randomized, double-blind, placebo-controlled 6-weeks trial of the efficacy and tolerability of 5 mg vortioxetine in adults with major depressive disorder. Int J Neuropsychopharmacol 16:313-321
15. Katona C, Hansen T, Olsen CK (2012) A randomized, double-blind, placebo-controlled, duloxetine-referenced, fixed-dose study comparing the efficacy and safety of Lu AA21004 in elderly patients with major depressive disorder. Int Clin Psychopharmacol 27:215-223
16. Khan A, Bhat A, Kolts R, Thase ME et al (2010) Why has the antidepressant-placebo difference in antidepressant clinical trials diminished over the past three decades? CNS Neurosci Ther 16:217-226
17. Mahableshwarkar AR, Jacobsen PL, Serenko M, Chen Y, Trivedi M (2013a) A duloxetine-referenced fixed dose study comparing efficacy and safety of 2 vortioxetine doses in the acute treatment of adult MDD patients [abstract]. American Psychiatric Association (APA) 166th Annual Meeting 2013 (manuscript submitted for publication J Clin Psych)
18. Mahableshwarkar AR, Jacobsen PL, Chen Y (2013b) A randomized, double-blind trial of 2.5 mg and 5 mg vortioxetine (Lu AA21004) versus placebo for 8 weeks in adults with major depressive disorder. Curr Med Res Opin 29:217-226
19. McGahuey CA, Gelenberg AJ, Laukes CA, Moreno FA, Delgado PL, McKnoght KM, Manber R (2000) The Arizona Sexual Experience Scale (ASEX): reliability and validity. J Sex Marital Ther 26:25-40
20. Montgomery SA, Asberg M (1979) A new depression scale designed to be sensitive to change. Br J Psychiatr 134:382-389
21. Mørk A, Pehrson A, Brennum L, Nielsen SM, Zhong H, Lassen AB, Miller S, Westrich L, Boyle NJ, Sanchez C, Fischer CW, Liebenberg N, Wegener G, Bundgaard C, Hogg S, Bang-Andersen B, Stensbøl TB (2012) Pharmacological effects of Lu AA21004: a novel multimodal compound for the treatment of major depressive disorder. J Pharmacol Exp Ther 340:666-675
22. Mundt JC, Greist JH, Jefferson JW, Katzelnick DJ et al (2007) Is it easier to find what you are looking for if you think you know what it looks like? J Clin Psychopharmacol 27:121-125
23. Pehrson AL, Cremers T, Betry C, van der Hart MG, Jørgensen L, Madsen M, Haddjeri N, Ebert B, Sanchez C (2013) Lu AA21004, a novel multimodal antidepressant, produces regionally selective increases of multiple neurotransmitters - a rat microdialysis and electrophysiology study. Eur Neuropsychopharmacol 23:133-145
24. Posner K, Brown GK, Stanley B, Brent DA, Yershova KV, Oguendo MA, Currier GW, Melvin GA, Greenhill L, Shen S, Mann JJ (2011) The Columbia-Suicide Severity Rating Scale: initial validity and internal consistency findings from three multisite studies with adolescents and adults. Am J Psychiatr 168:1266-1277
25. Rush AJ, Trivedi MH, Wisniewski SR, Nierenberg AA, Stewart JW, Warden D, Niederehe G, Thase ME, Lavori PW, Lebowitz BD, McGrath PJ, Rosenbaum JF, Sackeim HA, Kupfer DJ, Luther J, Fava M (2006) Acute and longer-term outcomes in depressed outpatients requiring one or several treatment steps: a STAR∗D report. Am J Psychiatr 163:1905-1917
26. Sanchez C, Asin K, Artigas F (2014) Vortioxetine, a novel antidepressant with multimodal activity: review of preclinical and clinical data. Pharmacol Ther. doi: 10.1016/j.pharmthera.2014.07.001
27. Serretti A, Chiesa A (2009) Treatment-emergent sexual dysfunction related to antidepressants: a meta-analysis. J Clin Psychopharmacol 29:259-266
28. Sheehan DV, Harnett-Sheehan K, Raj BA (1996) The measurement of disability. Int Clin Psychopharmacol 11:89-95
29. Trivedi MH, Rush AJ, Wisniewski SR, Nierenberg AA, Warden D, Ritz L, Norquist G, Howland RH, Lebowitz B, McGrath PJ, Shores-Wilson K, Biggs MM, Balasubramani GK, Fava M (2006) Evaluation of outcomes with citalopram for depression using measurement-based care in STAR∗D: implications for clinical practice. Am J Psychiatr 163:28-40