Evaluating the efficacy of vilazodone in achieving remission in patients with major depressive disorder: post-hoc analyses of a phase IV trial.
The aim of this study was to evaluate the efficacy of vilazodone using different definitions of remission. Post-hoc analyses were carried out using data from an 8-week, multicenter, randomized, double-blind, placebo-controlled trial of vilazodone 40 mg/day in adults with major depressive disorder (NCT01473394). The primary efficacy endpoint was a mean change in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score; additional measures included the Clinical Global Impressions-Severity (CGI-S) and Hamilton Rating Scale for Anxiety (HAMA) scores. In addition to treatment response (MADRS≥50% improvement), post-hoc analyses were carried out for remission of depressive symptoms [MADRS score≤10; MADRS≤5 (complete remission)], anxiety symptoms (HAMA≤7), and combined depression and anxiety symptoms (MADRS/HAMA≤10/≤7), as well as for overall symptom severity (CGI-S=1). Odds ratios (ORs) and numbers needed to treat (NNTs) were also calculated. Significant outcomes were obtained with vilazodone versus placebo for MADRS response (50.6 vs. 33.3%, OR=2.04, P<0.001, NNT=6), remission (34.0 vs. 21.8%, OR=1.82, P=0.003, NNT=9), and complete remission (18.2 vs. 8.3%, OR=2.42, P=0.002, NNT=11). More patients receiving vilazodone rather than placebo also met remission criteria for HAMA (48.8 vs. 35.2%, OR=1.82, P=0.002, NNT=8), MADRS/HAMA (32.1 vs. 20.4%, OR=1.83, P=0.004, NNT=9), and CGI-S (24.1 vs. 11.5%, OR=2.41, P<0.001, NNT=8). Treatment with vilazodone 40 mg/day may help adult patients with major depressive disorder achieve remission of depression and/or anxiety symptoms.
aDepartment of Psychiatry and Behavioral Sciences, New York Medical College, Valhalla, New York bForest Research Institute, Jersey City, New Jersey, USA.
Leslie
L
Citrome
Carl P
CP
Gommoll
Xiongwen
X
Tang
Rene
R
Nunez
Maju
M
Mathews
D000293:Adolescent; D000328:Adult; D000928:Antidepressive Agents / Q000627:therapeutic use; D001572:Benzofurans / Q000627:therapeutic use*; D003865:Major Depressive Disorder / Q000175:diagnosis* / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007211:Indoles / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D015233:Models, Statistical; D010879:Piperazines / Q000627:therapeutic use*; D011569:Psychiatric Status Rating Scales; D012074:Remission Induction; D063189:Symptom Assessment; D000069503:Vilazodone Hydrochloride; D055815:Young Adult
D000928:Antidepressive Agents; D001572:Benzofurans; D007211:Indoles; D010879:Piperazines; D000069503:Vilazodone Hydrochloride