Efficacy and safety of vilazodone in major depressive disorder: A randomized, double-blind, placebo-controlled trial

Journal of Clinical Psychiatry

Volumn 75, Issue 11, 2014, Pages e1291-e1298

  Croft, Harry A ^a   Pomara, Nunzio ^b   Gommoll, Carl ^c   Chen, Dalei ^c   Nunez, Rene ^c   Mathews, Maju ^c  

^a San Antonio Psychiatric Research Center   (United States)

^b NEW YORK UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c FOREST RESEARCH INSTITUTE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CREATINE KINASE; PLACEBO; VILAZODONE; BENZOFURAN DERIVATIVE; INDOLE DERIVATIVE; PIPERAZINE DERIVATIVE; SEROTONIN UPTAKE INHIBITOR;

ADULT; ANXIETY; ARTICLE; CLINICAL GLOBAL IMPRESSION SCALE; CONTROLLED STUDY; CREATINE KINASE BLOOD LEVEL; DEPRESSION; DIARRHEA; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG DOSE INCREASE; DRUG EFFECT; DRUG EFFICACY; DRUG OVERDOSE; DRUG RESPONSE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; EJACULATION DISORDER; ERECTILE DYSFUNCTION; FEMALE; HUMAN; INSOMNIA; IRRITABILITY; MAJOR CLINICAL STUDY; MAJOR DEPRESSION; MALE; MONTGOMERY ASBERG DEPRESSION RATING SCALE; MULTICENTER STUDY; NAUSEA; ORTHOSTATIC HYPOTENSION; PARALLEL DESIGN; PARESTHESIA; PRIORITY JOURNAL; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; SEXUAL DYSFUNCTION; SIDE EFFECT; SUICIDAL IDEATION; SUICIDE ATTEMPT; UPPER RESPIRATORY TRACT INFECTION; WEIGHT GAIN; DEPRESSIVE DISORDER, MAJOR; MIDDLE AGED; TREATMENT OUTCOME; YOUNG ADULT;

ADULT; BENZOFURANS; DEPRESSIVE DISORDER, MAJOR; DOUBLE-BLIND METHOD; HUMANS; INDOLES; MALE; MIDDLE AGED; PIPERAZINES; PLACEBOS; SEROTONIN UPTAKE INHIBITORS; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84922396936     PISSN: 01606689     EISSN: 15552101     Source Type: Journal    
DOI: 10.4088/JCP.14m08992     Document Type: Article

References (30)

1. Zimmerman M, Posternak M, Friedman M, et al. Which factors influence psychiatrists' selection of antidepressants? Am J Psychiatry. 2004;161(7):1285-1289. doi:10.176/api.ajp.161.7.1285 PubMed
2. Nutt DJ. Relationship of neurotransmitters to the symptoms of major depressive disorder. J Clin Psychiatry. 2008;69(suppl E1):4-7. PubMed
3. Taylor MJ. Rapid onset of true antidepressant action. Curr Psychiatry Rep. 2007;9(6):475-479. doi:10.107/s1920-07-064-0 PubMed
4. Taylor MJ, Freemantle N, Geddes JR, et al. Early onset of selective serotonin reuptake inhibitor antidepressant action: systematic review and metaanalysis. Arch Gen Psychiatry. 2006;63(11):1217-1223. doi:10.101/archpsyc.63.1.1217 PubMed
5. Trivedi MH, Rush AJ, Wisniewski SR, et al; STAR∗D Study Team. Evaluation of outcomes with citalopram for depression using measurement-based care in STAR∗D: implications for clinical practice. Am J Psychiatry. 2006;163(1):28-40. doi:10.176/api.ajp.163.1.28 PubMed
6. Zajecka JM. Treating depression to remission. J Clin Psychiatry. 2003;64(suppl 15):7-12. PubMed
7. Albert PR, François BL. Modifying 5-HT1A receptor gene expression as a new target for antidepressant therapy. Front Neurosci. 2010;4:35. PubMed
8. Blier P, Ward NM. Is there a role for 5-HT1A agonists in the treatment of depression? Biol Psychiatry. 2003;53(3):193-203. doi:10.1016/S06-323(02)01643-8 PubMed
9. Portella MJ, de Diego-Adeliño J, Ballesteros J, et al. Can we really accelerate and enhance the selective serotonin reuptake inhibitor antidepressant effect? a randomized clinical trial and a meta-analysis of pindolol in nonresistant depression. J Clin Psychiatry. 2011;72(7):962-969. doi:10.408/JCP.09m05827blu PubMed
10. Khan A, Cutler AJ, Kajdasz DK, et al. A randomized, double-blind, placebocontrolled, 8-week study of vilazodone, a serotonergic agent for the treatment of major depressive disorder. J Clin Psychiatry. 2011;72(4):441-447. doi:10.408/JCP.10m06596 PubMed
11. Rickels K, Athanasiou M, Robinson DS, et al. Evidence for efficacy and tolerability of vilazodone in the treatment of major depressive disorder: A randomized, double-blind, placebo-controlled trial. J Clin Psychiatry. 2009;70(3):326-333. doi:10.408/JCP.08m04637 PubMed
12. Robinson DS, Kajdasz DK, Gallipoli S, et al. A 1-year, open-label study assessing the safety and tolerability of vilazodone in patients with major depressive disorder. J Clin Psychopharmacol. 2011;31(5):643-646. PubMed
13. Liebowitz M, Croft HA, Kajdasz DK, et al. The safety and tolerability profile of vilazodone, a novel antidepressant for the treatment of major depressive disorder. Psychopharmacol Bull. 2011;44(3).
14. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision. Washington, DC: American Psychiatric Association; 2000.
15. Montgomery SA, Asberg M. A new depression scale designed to be sensitive to change. Br J Psychiatry. 1979;134(4):382-389. doi:10.192/bjp.134.4.382 PubMed
16. 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(12):1266-1277. doi:10.176/api.ajp.201.101704 PubMed
17. Guy W. The clinician global severity and impression scales. In: ECDEU Assessment Manual for Psychopharmacology. US Dept Health, Education, and Welfare publication (ADM) 76-338. Rockville, MD: National Institute of Mental Health; 1976;218-222.
18. Hamilton M. A rating scale for depression. J Neurol Neurosurg Psychiatry. 1960;23(1):56-62. doi:10.136/jnp.23.1.56 PubMed
19. Kenward MG, Roger JH. Small sample inference for fixed effects from restricted maximum likelihood. Biometrics. 1997;53(3):983-997. doi:10.2307/25358 PubMed
20. Kenward MG, Molenberghs G, Thijs H. Pattern-mixture models with proper time dependence. Biometrika. 2003;90(1):53-71. doi:10.1093/biomet/90.1.53
21. Watkins PB, Seligman PJ, Pears JS, et al. Using controlled clinical trials to learn more about acute drug-induced liver injury. Hepatology. 2008;48(5):1680-1689. doi:10.102/hep.263 PubMed
22. 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(4):464-472. doi:10.408/JCP.10m06191 PubMed
23. Montgomery SA, Möller HJ. Is the significant superiority of escitalopram compared with other antidepressants clinically relevant? Int Clin Psychopharmacol. 2009;24(3):111-118. doi:10.1097/YIC.0b013e32832a8eb2 PubMed
24. Rao S, Zisook S. Anxious depression: clinical features and treatment. Curr Psychiatry Rep. 2009;11(6):429-436. doi:10.107/s1920-09-065-2 PubMed
25. Wiethoff K, Bauer M, Baghai TC, et al. Prevalence and treatment outcome in anxious versus nonanxious depression: results from the German Algorithm Project. J Clin Psychiatry. 2010;71(8):1047-1054. doi:10.408/JCP.09m05650blu PubMed
26. Ferguson JM. SSRI antidepressant medications: adverse effects and tolerability. Prim Care Companion J Clin Psychiatry. 2001;3(1):22-27. doi:10.408/PC.v03n0105 PubMed
27. Clayton AH, Montejo AL. Major depressive disorder, antidepressants, and sexual dysfunction. J Clin Psychiatry. 2006;67(suppl 6):33-37. PubMed
28. Clayton AH, Pradko JF, Croft HA, et al. Prevalence of sexual dysfunction among newer antidepressants. J Clin Psychiatry. 2002;63(4):357-366. doi:10.408/JCP.v63n0414 PubMed
29. 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(7):959-965. doi:10.408/JCP.v65n0712 PubMed
30. Clayton AH, Kennedy SH, Edwards JB, et al. The effect of vilazodone on sexual function during the treatment of major depressive disorder. J Sex Med. 2013;10(10):2465-2476. PubMed