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Psych Congress  

Categorical Improvements in Disease Severity in MDD Patients Treated with Vilazodone: Post Hoc Analysis of 4 Randomized, Placebo-Controlled Trials

Raffaele Migliore, MA
Suresh Durgam, MD
Changzheng Chen, PhD
John Edwards, MD, MBA
Carl Gommoll, MS
Leslie Citrome, MD, MPH
Allergan, Inc.

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.

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