This poster was presented at the 29th Annual U.S. Psychiatric & Mental Health Congress, held October 21-24, 2016, in San Antonio, Texas.
Background: Four randomized, double-blind, placebo (PBO)-controlled studies of vilazodone (VLZ) 20-40 mg/d were conducted in adults with major depressive disorder (MDD) (8 weeks: NCT00285376, NCT00683592, NCT01473394; 10 weeks: NCT01473381). Change from baseline in Clinical Global Impression of Severity (CGI-S) score was included as an efficacy parameter in all studies. To assess the proportion of patients achieving clinically meaningful improvement, a post hoc analysis was conducted using categorical shifts in disease severity based on CGI-S scores at baseline and end of treatment (EOT).
Methods: Analyses were conducted in the pooled intent-to-treat population (N=2218). Categorical improvements in global disease severity were defined as follows: CGI-S score ≥4 (moderately ill or worse) at baseline and CGI-S score ≤2 (normal or borderline ill) at EOT; or CGI-S score ≥5 (markedly ill or worse) at baseline and CGI-S score ≤2 at EOT. Categorical shifts were analyzed using a logistic regression model.
Results: At baseline, 2217 patients were moderately ill or worse (placebo=964, VLZ=1253) and 979 were markedly ill or worse (PBO=435, VLZ=544). In patients with baseline CGI-S score ≥4, the proportion who improved to CGI-S score ≤2 at EOT was significantly higher with VLZ than with PBO (40.0% vs 27.8%; odds ratio [OR]=1.7, P<.001; number needed to treat [NNT]=9). Similar results were found in patients with baseline CGI-S score ≥5 (36.8% vs 25.5%; OR=1.7, P<.001; NNT=9).
Conclusions: Categorical shift analyses, defined using baseline and EOT CGI-S scores, showed that more patients had clinically meaningful improvements in global disease severity with VLZ 20-40 mg/d versus PBO.