Efficacy and safety of vilazodone 20 and 40mg in major depressive disorder: A randomized, double-blind, placebo-controlled trial

International Clinical Psychopharmacology

Volumn 30, Issue 2, 2015, Pages 67-74

  Mathews, Maju ^a   Gommoll, Carl ^a   Chen, Dalei ^a   Nunez, Rene ^a   Khan, Arif ^b,c  

^a FOREST RESEARCH INSTITUTE   (United States)

^b Northwest Clinical Research Center   (United States)

^c DUKE UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

5 HT1A partial agonist; antidepressant; major depressive disorder; selective serotonin reuptake inhibitor; sexual dysfunction; vilazodone

Indexed keywords

CITALOPRAM; PLACEBO; VILAZODONE; ANTIDEPRESSANT AGENT; BENZOFURAN DERIVATIVE; INDOLE DERIVATIVE; PIPERAZINE DERIVATIVE;

ADULT; AGED; ANORGASMIA; ARTICLE; CLINICAL GLOBAL IMPRESSION SCALE; CONTROLLED STUDY; DIARRHEA; DISEASE SEVERITY; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; EJACULATION DISORDER; FATIGUE; FEMALE; HEADACHE; HUMAN; INSOMNIA; LIBIDO DISORDER; MAJOR DEPRESSION; MALE; MONTGOMERY ASBERG DEPRESSION RATING SCALE; MULTICENTER STUDY; NAUSEA; PREMATURE EJACULATION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; SEXUAL DYSFUNCTION; SEXUAL FUNCTION; SUICIDAL IDEATION; TREATMENT RESPONSE; UPPER RESPIRATORY TRACT INFECTION; VOMITING; XEROSTOMIA; ADOLESCENT; CLINICAL TRIAL; DEPRESSIVE DISORDER, MAJOR; DOSE RESPONSE; MIDDLE AGED; PSYCHOLOGICAL RATING SCALE; TREATMENT OUTCOME; YOUNG ADULT;

ADOLESCENT; ADULT; AGED; ANTIDEPRESSIVE AGENTS; BENZOFURANS; CITALOPRAM; DEPRESSIVE DISORDER, MAJOR; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; FEMALE; HUMANS; INDOLES; MALE; MIDDLE AGED; PIPERAZINES; PSYCHIATRIC STATUS RATING SCALES; TREATMENT OUTCOME; VILAZODONE HYDROCHLORIDE; YOUNG ADULT;

EID: 84922400825     PISSN: 02681315     EISSN: 14735857     Source Type: Journal    
DOI: 10.1097/YIC.0000000000000057     Document Type: Article

References (24)

1. APA (2000). Diagnostic and Statistical Manual of Mental Disorders, text revision. 4th ed. Washington, DC: American Psychiatric Association.
2. Bull SA, Hu XH, Hunkeler EM, Lee JY, Ming EE, Markson LE, Fireman B (2002). Discontinuation of use and switching of antidepressants: influence of patientphysician communication. JAMA 288:1403-1409.
3. Cassano P, Fava M (2004). Tolerability issues during long-term treatment with antidepressants. Ann Clin Psychiatry 16:15-25.
4. Chen X, Luo X, Capizzi T (2005). The application of enhanced parallel gatekeeping strategies. Stat Med 24:1385-1397.
5. Clayton AH, McGarvey EL, Clavet GJ, Piazza L (1997). Comparison of sexual functioning in clinical and nonclinical populations using the Changes in Sexual Functioning Questionnaire (CSFQ). Psychopharmacol Bull 33:747-753.
6. Demyttenaere K, Enzlin P, Dewé W, Boulanger B, De Bie J, De Troyer W, Mesters P (2001). Compliance with antidepressants in a primary care setting, 2: the influence of gender and type of impairment. J Clin Psychiatry 62 Suppl 22:34-37.
7. Guy W (1976). The clinician global severity and impression scales. ECDEU assessment manual for psychopharmacology. Rockville, MD: National Institute of Mental Health 218-222.
8. Hamilton M (1959). The assessment of anxiety states by rating. Br J Med Psychol 32:50-55.
9. Hochberg Y (1988). A Sharper Bonferroni procedure for multiple tests of significance. Biometrika 75:800-802.
10. Hu XH, Bull SA, Hunkeler EM, Ming E, Lee JY, Fireman B, Markson LE (2004). 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 65:959-965.
11. Kenward MG, Molenberghs G, Thijs H (2003). Pattern-mixture models with proper time dependence. Biometrika 90:53-71.
12. Khan A, Cutler AJ, Kajdasz DK, Gallipoli S, Athanasiou M, Robinson DS, et al. (2011). A randomized, double-blind, placebo-controlled, 8-week study of vilazodone, a serotonergic agent for the treatment of major depressive disorder. J Clin Psychiatry 72:441-447.
13. Melander H, Salmonson T, Abadie E, van Zwieten-Boot B (2008). A regulatory Apologia-a review of placebo-controlled studies in regulatory submissions of new-generation antidepressants. Eur Neuropsychopharmacol 18:623-627.
14. Montgomery SA, Asberg M (1979). A new depression scale designed to be sensitive to change. Br J Psychiatry 134:382-389.
15. Montgomery SA, Möller HJ (2009). Is the significant superiority of escitalopram compared with other antidepressants clinically relevant? Int Clin Psychopharmacol 24:111-118.
16. Papakostas GI (2008). Tolerability of modern antidepressants. J Clin Psychiatry 69 (Suppl E1):8-13.
17. Pomara N, Gommoll C, Chen D, Nunez R, Mathews M, Croft H (2013). Efficacy and safety of vilazodone in major depressive disorder: a randomized, doubleblind, placebo-controlled trial. Neuropsychopharmacol S378-S379.
18. Posner K, Brown GK, Stanley B, Brent DA, Yershova KV, Oquendo MA, et al. (2011). The Columbia-Suicide Severity Rating Scale: initial validity and internal consistency findings from three multisite studies with adolescents and adults. Am J Psychiatry 168:1266-1277.
19. Rickels K, Athanasiou M, Robinson DS, Gibertini M, Whalen H, Reed CR (2009). Evidence for efficacy and tolerability of vilazodone in the treatment of major depressive disorder: a randomized, double-blind, placebo-controlled trial. J Clin Psychiatry 70:326-333.
20. Robinson DS, Kajdasz DK, Gallipoli S, Whalen H, Wamil A, Reed CR (2011). A 1-year, open-label study assessing the safety and tolerability of vilazodone in patients with major depressive disorder. J Clin Psychopharmacol 31:643-646.
21. Rush AJ (2007). STAR, D: what have we learned? Am J Psychiatry 164:201-204.
22. Rush AJ, Trivedi MH, Wisniewski SR, Stewart JW, Nierenberg AA, Thase ME, et al. STAR, D Study Team (2006). Bupropion-SR, sertraline, or venlafaxine-XR after failure of SSRIs for depression. N Engl J Med 354:1231-1242.
23. Targum SD, Hassman H, Pinho M, Fava M (2012). Development of a clinical global impression scale for fatigue. J Psychiatr Res 46:370-374.
24. Watkins PB, Seligman PJ, Pears JS, Avigan MI, Senior JR (2008). Using controlled clinical trials to learn more about acute drug-induced liver injury. Hepatology 48:1680-1689.