A randomized, double-blind, fixed-dose study comparing the efficacy and tolerability of vortioxetine 2.5 and 10 mg in acute treatment of adults with generalized anxiety disorder

Human Psychopharmacology

Volumn 29, Issue 1, 2014, Pages 64-72

  Mahableshwarkar, Atul R ^a   Jacobsen, Paula L ^a   Serenko, Michael ^a   Chen, Yinzhong ^a  

^a TAKEDA DEVELOPMENT CENTER AMERICAS   (United States)

Author keywords

general anxiety disorder; multimodal therapy; vortioxetine

Indexed keywords

PLACEBO; VORTIOXETINE;

ADULT; ARTICLE; CLINICAL GLOBAL IMPRESSION SCALE; CONSTIPATION; CONTROLLED STUDY; DIARRHEA; DOUBLE BLIND PROCEDURE; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; GENERALIZED ANXIETY DISORDER; HAMILTON ANXIETY SCALE; HOSPITAL ANXIETY AND DEPRESSION SCALE; HUMAN; INFECTION; INGUINAL HERNIA; MALE; MULTICENTER STUDY; NAUSEA; OUTCOME ASSESSMENT; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; PSYCHOPHARMACOTHERAPY; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; RISK ASSESSMENT; SELF REPORT; SHEEHAN DISABILITY SCALE; SHORT FORM 36; SPONTANEOUS ABORTION; TREATMENT RESPONSE; VOMITING; XEROSTOMIA; YOUNG ADULT;

GENERAL ANXIETY DISORDER; MULTIMODAL THERAPY; VORTIOXETINE;

ADULT; ANTI-ANXIETY AGENTS; ANXIETY DISORDERS; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; FEMALE; HUMANS; LEAST-SQUARES ANALYSIS; MALE; MIDDLE AGED; PIPERAZINES; PSYCHIATRIC STATUS RATING SCALES; SULFIDES; TREATMENT OUTCOME;

EID: 84892624637     PISSN: 08856222     EISSN: 10991077     Source Type: Journal    
DOI: 10.1002/hup.2371     Document Type: Article

References (27)

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. American Psychiatric Association. 2000. Anxiety disorder. In Diagnostic & Statistics Manual, 4th edn. American Psychiatric Association; 427-485.
3. Baldwin DS, Nutt DJ,. 2012. On assessing potential efficacy for vortioxetine in generalized anxiety disorder. Eur Neuropsychopharmacol 22: 841-843.
4. Baldwin DS, Waldman S, Allgulander C,. 2011. Evidence-based pharmacological treatment of generalized anxiety disorder. Int J Neuropsychopharmacol 14: 697-710.
5. Baldwin DS, Loft H, Florea I,. 2012. Lu AA21004, a multimodal psychotropic agent, in the prevention of relapse in adult patients with generalized anxiety disorder. Int Clin Psychopharmacol 27: 197-207.
6. Bandelow B, Zohar J, Hollander E, et al,. 2008. World Federation of Societies of Biological Psychiatry (WFSBP) guidelines for the pharmacological treatment of anxiety, obsessive-compulsive and post-traumatic stress disorders-first revision. World J Biol Psychiatry 9: 248-312.
7. Bang-Andersen B, Ruhland T, Jorgensen M, 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.
8. Bidzan L, Mahableshwarkar AR, Jacobsen P, Yan M, Sheehan DV,. 2012. Vortioxetine (Lu AA21004) in generalized anxiety disorder: results of an 8-week, multinational, randomized, double-blind, placebo-controlled clinical trial. Eur Neuropsychopharmacol 22: 847-857.
9. Bobes J, Caballero L, Vilardaga I, Rejas J,. 2011. Disability and health-related quality of life in outpatients with generalised anxiety disorder treated in psychiatric clinics: is there still room for improvement? Ann Gen Psychiatry 10: 7.
10. 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.
11. Boulenger JP, Loft H, Olsen CK,. 2013. Efficacy and safety of vortioxetine (Lu AA21004), 15 and 20 mg/day: a randomized, double-blind, placebo-controlled, duloxetine-referenced study in the acute treatment of adult patients with major depressive disorder. Int Clin Psychopharmacol [Epub ahead of print].
12. 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, pp. 217-222.
13. 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 Psychiatry 73: 953-959.
14. Hidalgo RB, Tupler LA, Davidson JR,. 2007. An effect-size analysis of pharmacologic treatments for generalized anxiety disorder. J Psychopharmacol 21: 864-872.
15. Jain R, Mahableshwarkar A, Jacobson P, Chen Y, Thase ME,. 2013. A randomized, double-blind, placebo-controlled 6-wk trial of the efficacy and tolerability of 5 mg vortioxetine in adults with major depressive disorder. Int J Neuropsychopharmacol 16: 313-321.
16. Khan A, Khan S, Brown WA,. 2002. Are placebo controls necessary to test new antidepressants and anxiolytics? Int J Neuropsychopharmacol 5: 193-197.
17. Khin NA, Chen YF, Yang Y, Yang P, Laughren TP,. 2011. 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 72: 464-472.
18. Mork A, Montezinho LC, Hovelso N, et al,. 2011. Lu AA21004, a novel antidepressant, modulates neurotransmitter levels and theta oscillations, and exerts pro-cognitive effects in rats. Eur Neuropsychopharmacol 21: s407-s408.
19. Mork A, Pehrson A, Brennum L, 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. Pehrson AL, Cremers T, Betry C, 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.
21. Posner K, Oquendo MA, Gould M, Stanley B, Davies M,. 2007. Columbia Classification Algorithm of Suicide Assessment (C-CASA): classification of suicidal events in the FDA's pediatric suicidal risk analysis of antidepressants. Am J Psychiatry 164: 1035-1043.
22. Rothschild AJ, Mahableshwarkar AR, Jacobsen P, Yan M, Sheehan DV,. 2012. Vortioxetine (Lu AA21004) 5mg in generalized anxiety disorder: results of an 8-week randomized, double-blind, placebo-controlled clinical trial in the United States. Eur Neuropsychopharmacol 22: 858-866.
23. Sheehan KH, Sheehan DV,. 2008. Assessing treatment effects in clinical trials with the discan metric of the Sheehan Disability Scale. Int Clin Psychopharmacol 23: 70-83.
24. Swinson RP, Antony MM, Bleau PB,. 2006. Clinical practice guidelines: management of anxiety disorders. Can J Psychiatry 51: 51s-55s.
25. Ware JE, Jr., Sherbourne CD,. 1992. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care 30: 473-483.
26. Westrich L, Pehrson A, Zhong H, 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.
27. Zigmond AS, Snaith RP,. 1983. The hospital anxiety and depression scale. Acta Psychiatr Scand 67: 361-370.