Abstract | BACKGROUND: 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.
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Authors | Carl Gommoll, Suresh Durgam, Maju Mathews, Giovanna Forero, Rene Nunez, Xiongwen Tang, Michael E Thase |
Journal | Depression and anxiety
(Depress Anxiety)
Vol. 32
Issue 6
Pg. 451-9
(Jun 2015)
ISSN: 1520-6394 [Electronic] United States |
PMID | 25891440
(Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | © 2015 The Authors. Depression and Anxiety published by Wiley Periodicals, Inc. |
Chemical References |
- Serotonin Uptake Inhibitors
- Vilazodone Hydrochloride
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Topics |
- Adult
- Anxiety Disorders
(diagnosis, drug therapy, psychology)
- Dose-Response Relationship, Drug
- Double-Blind Method
- Female
- Humans
- Male
- Middle Aged
- Selective Serotonin Reuptake Inhibitors
(therapeutic use)
- Surveys and Questionnaires
- Treatment Outcome
- Vilazodone Hydrochloride
(therapeutic use)
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