Citation

Culpepper L, Mathews M, Ghori R, Edwards J. Prim. Care Companion J. Clin. Psychiatry 2014; 16(1).

Copyright

(Copyright © 2014, Physicians Postgraduate Press)

DOI

10.4088/PCC.13m01571

PMID

unavailable

Abstract

OBJECTIVE: To assess clinically relevant symptom improvement in patients with major depressive disorder (MDD) receiving vilazodone by using the Montgomery-Asberg Depression Rating Scale (MADRS), a clinician-rated scale used to measure MDD symptom severity and improvement.

METHOD: Pooled data from 2 positive, phase 3, 8-week, double-blind, randomized, placebo-controlled trials in patients with MDD were analyzed. Patients received vilazodone 40 mg/d or placebo; post hoc analyses were conducted on study completers. Depression symptom improvement was evaluated by analyzing the proportions of patients who shifted from the baseline MADRS single-item symptom severity category of ≥ 2 (mild to severe symptoms) to an end-of-study category < 2 (minimal to no symptoms) or from ≥ 4 (moderate to severe symptoms) to ≤ 2 (mild to no symptoms). The proportion of patients who shifted from anxious depression to no anxious depression was also analyzed.

RESULTS: The percentage of patients who completed these studies with severity category shift from baseline ≥ 2 to end of study; 2 was significantly higher for vilazodone versus placebo on all MADRS items (odds ratio [OR] range, 1.4-1.7, P < 05) except reduced appetite (OR = 1.3, P = 232). A significantly greater proportion of vilazodone-treated versus placebo-treated patients shifted from baseline ≥ 4 to end of study ≤ 2 on MADRS items of apparent sadness, reported sadness, inner tension, reduced sleep, and lassitude (OR range, 1.5-2.0, P < 05). Additionally, a significantly greater proportion of vilazodone-treated versus placebo-treated patients shifted from anxious depression at baseline to no anxious depression at end of study (OR = 1.5, P = 031).

CONCLUSIONS: These results suggest that vilazodone treatment is associated with clinically relevant changes in depression symptoms in patients with MDD. © 2014 Physicians Postgraduate Press, Inc.

Language: en

Keywords

adult; human; female; male; randomized controlled trial; suicide attempt; major depression; disease severity; article; major clinical study; controlled study; double blind procedure; phase 3 clinical trial; middle aged; anxiety disorder; sleep disorder; placebo; follow up; drug efficacy; drug withdrawal; multicenter study; thought disorder; unspecified side effect; mental concentration; Montgomery Asberg Depression Rating Scale; outcome assessment; lassitude; tension; vilazodone