Safety and tolerability of vortioxetine (15 and 20 mg) in patients with major depressive disorder: Results of an open-label, flexible-dose, 52-week extension study

International Clinical Psychopharmacology

Volumn 30, Issue 5, 2015, Pages 255-264

  Jacobsen, Paula L ^a   Harper, Linda ^b   Chrones, Lambros ^a   Chan, Serena ^a   Mahableshwarkar, Atul R ^a  

^a TAKEDA DEVELOPMENT CENTER AMERICAS   (United States)

^b CNS Healthcare   (United States)

Author keywords

antidepressant; major depressive disorder; vortioxetine

Indexed keywords

AGOMELATINE; DULOXETINE; PLACEBO; VORTIOXETINE; ANTIDEPRESSANT AGENT; PIPERAZINE DERIVATIVE; SULFIDE;

ACUTE CHOLECYSTITIS; ADULT; AGED; ANXIETY; ARTICLE; BREAST CANCER; CLINICAL EFFECTIVENESS; CLINICAL GLOBAL IMPRESSION SCALE; COLUMBIA SUICIDE SEVERITY RATING SCALE; CONSTIPATION; CONTROLLED STUDY; DIARRHEA; DOUBLE BLIND PROCEDURE; DRUG DOSE INCREASE; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; EJACULATION DISORDER; ERECTILE DYSFUNCTION; FEMALE; HAMILTON ANXIETY SCALE; HEADACHE; HUMAN; INSOMNIA; LIVER TOXICITY; LONG TERM CARE; LONG TERM EXPOSURE; MAJOR CLINICAL STUDY; MAJOR DEPRESSION; MALE; MALE SEXUAL DYSFUNCTION; MONTGOMERY ASBERG DEPRESSION RATING SCALE; MULTICENTER STUDY; NAUSEA; OPEN STUDY; PHASE 3 CLINICAL TRIAL; PHYSICAL EXAMINATION; PRIORITY JOURNAL; QTC INTERVAL; RANDOMIZED CONTROLLED TRIAL; RATING SCALE; RHINOPHARYNGITIS; SEXUAL DYSFUNCTION; SHEEHAN DISABILITY SCALE; SIDE EFFECT; SUICIDAL IDEATION; SUICIDE ATTEMPT; TREATMENT DURATION; UPPER RESPIRATORY TRACT INFECTION; VIRAL UPPER RESPIRATORY TRACT INFECTION; VITAL SIGN; VOMITING; WEIGHT GAIN; CLINICAL TRIAL; DEPRESSIVE DISORDER, MAJOR; MIDDLE AGED; TREATMENT OUTCOME;

ADULT; ANTIDEPRESSIVE AGENTS; DEPRESSIVE DISORDER, MAJOR; DOUBLE-BLIND METHOD; FEMALE; HUMANS; MALE; MIDDLE AGED; PIPERAZINES; SULFIDES; TREATMENT OUTCOME;

EID: 84939515594     PISSN: 02681315     EISSN: 14735857     Source Type: Journal    
DOI: 10.1097/YIC.0000000000000081     Document Type: Article

References (28)

1. Alam MY, Jacobsen PL, Chen Y, Serenko M, Mahableshwarkar AR. (2014). Safety, tolerability, and efficacy of vortioxetine (Lu AA21004) in major depressive disorder: results of an open-label, flexible-dose, 52-week extension study. Int Clin Psychopharmacol 29: 36-44
2. Angst J. (1992). How recurrent and predictable is depressive disorder?. In: Montgomery S, Rouillon F, editors Long-term treatment of depression; perspectives in psychiatry Vol 3. Chichester, UK: John Wiley & Sons. p. 13
3. Baldwin DS, Hansen T, Florea I. (2012). Vortioxetine (Lu AA21004) in the longterm open-label treatment of major depressive disorder. Curr Med Res Opin 28: 1717-1724
4. Bang-Andersen B, Ruhland T, Jørgensen M, Smith G, Frederiksen K, Jensen KG, et al. (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. Cooke MJ, Waring WS. (2013). Citalopram and cardiac toxicity. Eur J Clin Pharmacol 69: 755-760
6. Corruble E, Guelfi JD. (2000). Pain complaints in depressed inpatients. Psychopathology 33: 307-309
7. Filippov G, Christens P. (2013). P.2.b.011 Vortioxetine (Lu AA21004) 15 and 20 mg/day: open-label long-term safety and tolerability in major depressive disorder (abstract). Eur Neuropsychopharmacol 23: S325
8. Florea I, Dragheim M, Loft H. (2012). P.2.c.010 The multimodal antidepressant Lu AA21004: open-label long-term safety and tolerability study in major depressive disorder. Eur Neuropsychopharmacol 22: S255-S256
9. Gilmer WS, Trivedi MH, Rush AJ, Wisniewski SR, Luther J, Howland RH, et al. (2005). Factors associated with chronic depressive episodes: a preliminary report from the STAR-D project. Acta Psychiatr Scand 112: 425-433
10. Jacobsen PL, Mahableshwarkar A, Serenko M, Chan S, Trivedi M. (2015a). 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. J Clin Psychiatry (in press
11. Jacobsen PL, Mahableshwarkar AR, Chen Y, Chrones L, Clayton AH. (2015b). A randomized, double-blind, head-to-head, flexible-dose study of vortioxetine versus escitalopram on sexual functioning in adults with well-treated major depressive disorder experiencing treatment-emergent sexual dysfunction. J Sex Med (in press
12. Kessler RC, Birnbaum HG, Shahly V, Bromet E, Hwang I, McLaughlin KA, et al. (2010). Age differences in the prevalence and co-morbidity of DSM-IV major depressive episodes: results from the WHO World Mental Health Survey Initiative. Depress Anxiety 27: 351-364
13. Kroenke K, Price RK. (1993). Symptoms in the community. Prevalence, classification, and psychiatric comorbidity. Arch Intern Med 153: 2474-2480
14. Mahableshwarkar AR, Jacobsen P, Serenko M, Chen Y, Trivedi M. (2015a). A randomized, double-blind, placebo-controlled study of the efficacy and safety of 2 doses of vortioxetine in adults with major depressive disorder. J Clin Psychiatry (in press
15. Mahableshwarkar AR, Jacobsen PL, Chen Y, Serenko M, Trivedi MH. (2015b). 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 (Berl) [Epub ahead of print
16. Montastruc F, Scotto S, Vaz IR, Guerra LN, Escudero A, Sáinz M, et al. (2014). Hepatotoxicity related to agomelatine and other new antidepressants: a case/noncase approach with information from the Portuguese, French, Spanish, and Italian pharmacovigilance systems. J Clin Psychopharmacol 34: 327-330
17. Montgomery SA. (2006). Why do we need new and better antidepressants?. Int Clin Psychopharmacol 21 (Suppl 1): S1-S10
18. Montgomery SA, Nielsen RZ, Poulsen LH, Häggström L. (2014). A randomised, double-blind study in adults with major depressive disorder with an inadequate response to a single course of selective serotonin reuptake inhibitor or serotonin-noradrenaline reuptake inhibitor treatment switched to vortioxetine or agomelatine. Hum Psychopharmacol 29: 470-482
19. Mørk A, Pehrson A, Brennum LT, Nielsen SM, Zhong H, Lassen AB, et al. (2012). Pharmacological effects of Lu AA21004: a novel multimodal compound for the treatment of major depressive disorder. J Pharmacol Exp Ther 340: 666-675
20. Mørk A, Montezinho LP, Miller S, Trippodi-Murphy C, Plath N, Li Y, et al. (2013). Vortioxetine (Lu AA21004), a novel multimodal antidepressant, enhances memory in rats. Pharmacol Biochem Behav 105: 41-50
21. Mueller TI, Leon AC, Keller MB, Solomon DA, Endicott J, Coryell W, et al. (1999). Recurrence after recovery from major depressive disorder during 15 years of observational follow-up. Am J Psychiatry 156: 1000-1006
22. National Collaborating Centre for Mental Health (NCCMH) (2010). National Institute for Health and Clinical Excellence: Guidance Depression: the treatment and management of depression in adults (updated edition). Leicester, UK: The British Psychological Society & The Royal College of Psychiatrists
23. Papakostas GI. (2014). Cognitive symptoms in patients with major depressive disorder and their implications for clinical practice. J Clin Psychiatry 75: 8-14
24. Pehrson AL, Sanchez C. (2014). Serotonergic modulation of glutamate neurotransmission as a strategy for treating depression and cognitive dysfunction. CNS Spectr 19: 121-133
25. Pehrson AL, Cremers T, Bétry C, van Der Hart MG, Jørgensen L, Madsen M, et al. (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
26. Torpey DC, Klein DN. (2008). Chronic depression: update on classification and treatment. Curr Psychiatry Rep 10: 458-464
27. Wang Y, Nomikos GG, Karim A, Munsaka M, Serenko M, Liosatos M, et al. (2013). Effect of vortioxetine on cardiac repolarization in healthy adult male subjects: results of a thorough QT/QTc study. Clin Pharmacol Drug Dev 2: 298-309
28. Westrich L, Pehrson A, Zhong H, Nielsen SM, Frederiksen K, Stensbol TB, et al. (2012). In vitro and in vivo effects for the multimodal antidepressant vortioxetine (Lu AA21004) at human and rat targets. Int J Psychiatry Clin Pract 16: 47