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A DOUBLE‐BLIND, RANDOMIZED, PLACEBO‐CONTROLLED, FIXED‐DOSE PHASE III STUDY OF VILAZODONE IN PATIENTS WITH GENERALIZED ANXIETY DISORDER
Author(s) -
Gommoll Carl,
Durgam Suresh,
Mathews Maju,
Forero Giovanna,
Nunez Rene,
Tang Xiongwen,
Thase Michael E.
Publication year - 2015
Publication title -
depression and anxiety
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.634
H-Index - 129
eISSN - 1520-6394
pISSN - 1091-4269
DOI - 10.1002/da.22365
Subject(s) - placebo , nausea , partial agonist , medicine , repeated measures design , generalized anxiety disorder , major depressive disorder , adverse effect , anxiety , psychology , anesthesia , psychiatry , agonist , receptor , statistics , alternative medicine , mathematics , pathology , amygdala
Background Vilazodone, a selective serotonin reuptake inhibitor and 5‐HT 1A receptor partial agonist, is approved for treating major depressive disorder in adults. This study (NCT01629966 ClinicalTrials.gov ) evaluated the efficacy and safety of vilazodone in adults with generalized anxiety disorder (GAD). Methods A multicenter, double‐blind, parallel‐group, placebo‐controlled, fixed‐dose study in patients with GAD randomized (1:1:1) to placebo ( n = 223), or vilazodone 20 mg/day ( n = 230) or 40 mg/day ( n = 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. Results 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]; P = .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 ( P = .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. Conclusions Vilazodone was effective in treating anxiety symptoms of GAD. No new safety concerns were identified.