Early and sustained improvement with vilazodone in adult patients with major depressive disorder: post hoc analyses of two phase III trials

Abstract

Objective:

To retrospectively examine the timing of depressive symptom improvement in patients treated with vilazodone, a selective serotonin reuptake inhibitor (SSRI) and 5-HT_1A partial agonist.

Research design and methods:

Post hoc analyses were conducted on pooled data from two phase III, multicenter, 8 week, double-blind, randomized, controlled trials (RCTs) of vilazodone 40 mg/day or placebo in adult patients with major depressive disorder (MDD).

Clinical trial registration:

ClinicalTrials.gov identifier: NCT00285376.

ClinicalTrials.gov identifier: NCT00683592.

Main outcome measures:

Montgomery–Åsberg Depression Rating Scale (MADRS) total score least squares (LS) mean change from baseline to Week 8; MADRS single items LS mean change from baseline; MADRS responder analyses: response = ≥50% reduction in baseline score; cumulative response = proportion of patients at each assessment who achieved response that was sustained at all subsequent weeks; sustained response = ≥50% reduction in baseline MADRS total score at last two visits; and sustained response plus MADRS score ≤12 at the last two visits of the study.

Results:

LS mean difference (LSMD) and 95% confidence interval (95% CI) for change from baseline to Week 8 was significantly greater in favor of vilazodone versus placebo (−2.8 [−4.1 to −1.4]; p < 0.0001); differences between vilazodone and placebo were statistically significant beginning at Week 1. Early improvement in depressive symptoms was suggested by statistically significant separation from placebo on seven of ten MADRS single items as early as Week 1 or Week 2. A significantly greater proportion of vilazodone patients achieved response using all responder criteria, with early and sustained improvement consistently observed.

Conclusions:

Early and sustained improvement of depressive symptoms was retrospectively observed in patients treated with vilazodone; early findings may be related to overall treatment outcomes.

Keywords::

• Major depressive disorder
• Selective serotonin reuptake inhibitors
• Serotonin 5-HT_1A receptor agonists
• Vilazodone

Transparency

Declaration of funding

This study was funded by PGxHealth LLC, a subsidiary of Clinical Data Inc. (acquired by Forest Laboratories Inc.). The development of this paper was supported by funding from Forest Laboratories Inc.

Declaration of financial/other relationships

D.C., J.E., and M.M. have disclosed that they are full-time employees of Forest Laboratories Inc. R.J. is a speaker for Forest Laboratories and has received research support from Forest Laboratories Inc., AstraZeneca, Eli Lilly, Pfizer and Shire. He has served as a consultant and speaker for Addrenex, Forest, Eli Lilly, Merck, Pamlab, Pfizer, Shinogi, Shire and Sunovian, and has served on the Advisory Boards of Addrenex, Eli Lilly, Merck, Pamlab, Pfizer, Shinogi, Shire and Sunovian.

CMRO peer reviewers may have received honoraria for their review work. The peer reviewers on this manuscript have disclosed that they have no relevant financial relationships.

Acknowledgements

The authors thank Prescott Medical Communications Group, Chicago, IL, USA for editorial assistance and technical writing, funded by Forest Laboratories Inc.

Previous presentation: The data in this paper were presented at the 166th Annual American Psychiatric Association Meeting, May 18–22, 2013, San Francisco, CA, USA.