A DOUBLE‐BLIND, RANDOMIZED, PLACEBO‐CONTROLLED, FIXED‐DOSE PHASE III STUDY OF VILAZODONE IN PATIENTS WITH GENERALIZED ANXIETY DISORDER. Issue 6 (17th April 2015)

• Record Type: Journal Article
• Authors: Gommoll, Carl; Durgam, Suresh; Mathews, Maju; Forero, Giovanna; Nunez, Rene; Tang, Xiongwen; Thase, Michael E.
• Is Part Of: Depression and anxiety. Volume 32:Issue 6(2015:Jun.)
• Page Start: 451
• Page End: 459
• Publication Date: 2015-04-17
• Subjects: Anxiety -- Periodicals; Depression, Mental -- Periodicals; Depression -- Periodicals; Anxiety -- Periodicals; Anxiety Disorders -- Periodicals; 616.8527005
• DOI: 10.1002/da.22365
• Languages: English
• ISSNs: 1091-4269

Abstract

<abstract abstract-type="main"> <title> <x xml:space="preserve">Abstract</x> </title> <sec id="da22365-sec-0010" sec-type="section"> <title>Background</title> <p>Vilazodone, a selective serotonin reuptake inhibitor and 5‐HT<sub>1A</sub> receptor partial agonist, is approved for treating major depressive disorder in adults. This study (NCT01629966 <ext-link ext-link-type="uri" xlink:href="http://ClinicalTrials.gov" xlink:type="simple" xmlns:xlink="http://www.w3.org/1999/xlink">ClinicalTrials.gov</ext-link>) evaluated the efficacy and safety of vilazodone in adults with generalized anxiety disorder (GAD).</p> </sec> <sec id="da22365-sec-0020" sec-type="section"> <title>Methods</title> <p>A multicenter, double‐blind, parallel‐group, placebo‐controlled, fixed‐dose study in patients with GAD randomized (1:1:1) to placebo (<italic>n</italic> = 223), or vilazodone 20 mg/day (<italic>n</italic> = 230) or 40 mg/day (<italic>n</italic> = 227). Primary and secondary efficacy parameters were total score change from baseline to week 8 on the Hamilton Rating Scale for Anxiety (HAMA) and Sheehan Disability Scale (SDS), respectively, analyzed using a predefined mixed‐effect model for repeated measures (MMRM). Safety outcomes were presented by descriptive statistics.</p> </sec> <sec id="da22365-sec-0030" sec-type="section"> <title>Results</title> <p>The least squares mean difference (95% confidence interval) in HAMA total score change from baseline (MMRM) was statistically significant for vilazodone 40 mg/day versus placebo (–1.80 [–3.26, –0.34]; <italic>P</italic> = .0312 [adjusted for multiple comparisons]), but not for vilazodone 20 mg/day versus placebo. Mean change from baseline in SDS total score was not significantly different for either dose of vilazodone versus placebo when adjusted for multiplicity; significant improvement versus placebo was noted for vilazodone 40 mg/day without adjustment for multiplicity (<italic>P</italic> = .0349). The incidence of adverse events was similar for vilazodone 20 and 40 mg/day (∼71%) and slightly lower for placebo (62%). Nausea, diarrhea, dizziness, vomiting, and fatigue were reported in ≥5% of patients in either vilazodone group and at least twice the rate of placebo.</p> </sec> <sec id="da22365-sec-0040" sec-type="section"> <title>Conclusions</title> <p>Vilazodone was effective in treating anxiety symptoms of GAD. No new safety concerns were identified.</p> </sec> </abstract>