Cargando…

A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, FIXED-DOSE PHASE III STUDY OF VILAZODONE IN PATIENTS WITH GENERALIZED ANXIETY DISORDER

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 disorde...

Descripción completa

Detalles Bibliográficos
Autores principales: Gommoll, Carl, Durgam, Suresh, Mathews, Maju, Forero, Giovanna, Nunez, Rene, Tang, Xiongwen, Thase, Michael E
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley & Sons, Ltd 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4676920/
https://www.ncbi.nlm.nih.gov/pubmed/25891440
http://dx.doi.org/10.1002/da.22365
_version_ 1782405257576316928
author Gommoll, Carl
Durgam, Suresh
Mathews, Maju
Forero, Giovanna
Nunez, Rene
Tang, Xiongwen
Thase, Michael E
author_facet Gommoll, Carl
Durgam, Suresh
Mathews, Maju
Forero, Giovanna
Nunez, Rene
Tang, Xiongwen
Thase, Michael E
author_sort Gommoll, Carl
collection PubMed
description 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.
format Online
Article
Text
id pubmed-4676920
institution National Center for Biotechnology Information
language English
publishDate 2015
publisher John Wiley & Sons, Ltd
record_format MEDLINE/PubMed
spelling pubmed-46769202015-12-20 A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, FIXED-DOSE PHASE III STUDY OF VILAZODONE IN PATIENTS WITH GENERALIZED ANXIETY DISORDER Gommoll, Carl Durgam, Suresh Mathews, Maju Forero, Giovanna Nunez, Rene Tang, Xiongwen Thase, Michael E Depress Anxiety Research Articles 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. John Wiley & Sons, Ltd 2015-06 2015-04-17 /pmc/articles/PMC4676920/ /pubmed/25891440 http://dx.doi.org/10.1002/da.22365 Text en © 2015 The Authors. Depression and Anxiety published by Wiley Periodicals, Inc. http://creativecommons.org/licenses/by-nc This is an open access article under the terms of the Creative Commons Attribution-NonCommercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.
spellingShingle Research Articles
Gommoll, Carl
Durgam, Suresh
Mathews, Maju
Forero, Giovanna
Nunez, Rene
Tang, Xiongwen
Thase, Michael E
A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, FIXED-DOSE PHASE III STUDY OF VILAZODONE IN PATIENTS WITH GENERALIZED ANXIETY DISORDER
title A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, FIXED-DOSE PHASE III STUDY OF VILAZODONE IN PATIENTS WITH GENERALIZED ANXIETY DISORDER
title_full A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, FIXED-DOSE PHASE III STUDY OF VILAZODONE IN PATIENTS WITH GENERALIZED ANXIETY DISORDER
title_fullStr A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, FIXED-DOSE PHASE III STUDY OF VILAZODONE IN PATIENTS WITH GENERALIZED ANXIETY DISORDER
title_full_unstemmed A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, FIXED-DOSE PHASE III STUDY OF VILAZODONE IN PATIENTS WITH GENERALIZED ANXIETY DISORDER
title_short A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, FIXED-DOSE PHASE III STUDY OF VILAZODONE IN PATIENTS WITH GENERALIZED ANXIETY DISORDER
title_sort double-blind, randomized, placebo-controlled, fixed-dose phase iii study of vilazodone in patients with generalized anxiety disorder
topic Research Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4676920/
https://www.ncbi.nlm.nih.gov/pubmed/25891440
http://dx.doi.org/10.1002/da.22365
work_keys_str_mv AT gommollcarl adoubleblindrandomizedplacebocontrolledfixeddosephaseiiistudyofvilazodoneinpatientswithgeneralizedanxietydisorder
AT durgamsuresh adoubleblindrandomizedplacebocontrolledfixeddosephaseiiistudyofvilazodoneinpatientswithgeneralizedanxietydisorder
AT mathewsmaju adoubleblindrandomizedplacebocontrolledfixeddosephaseiiistudyofvilazodoneinpatientswithgeneralizedanxietydisorder
AT forerogiovanna adoubleblindrandomizedplacebocontrolledfixeddosephaseiiistudyofvilazodoneinpatientswithgeneralizedanxietydisorder
AT nunezrene adoubleblindrandomizedplacebocontrolledfixeddosephaseiiistudyofvilazodoneinpatientswithgeneralizedanxietydisorder
AT tangxiongwen adoubleblindrandomizedplacebocontrolledfixeddosephaseiiistudyofvilazodoneinpatientswithgeneralizedanxietydisorder
AT thasemichaele adoubleblindrandomizedplacebocontrolledfixeddosephaseiiistudyofvilazodoneinpatientswithgeneralizedanxietydisorder
AT gommollcarl doubleblindrandomizedplacebocontrolledfixeddosephaseiiistudyofvilazodoneinpatientswithgeneralizedanxietydisorder
AT durgamsuresh doubleblindrandomizedplacebocontrolledfixeddosephaseiiistudyofvilazodoneinpatientswithgeneralizedanxietydisorder
AT mathewsmaju doubleblindrandomizedplacebocontrolledfixeddosephaseiiistudyofvilazodoneinpatientswithgeneralizedanxietydisorder
AT forerogiovanna doubleblindrandomizedplacebocontrolledfixeddosephaseiiistudyofvilazodoneinpatientswithgeneralizedanxietydisorder
AT nunezrene doubleblindrandomizedplacebocontrolledfixeddosephaseiiistudyofvilazodoneinpatientswithgeneralizedanxietydisorder
AT tangxiongwen doubleblindrandomizedplacebocontrolledfixeddosephaseiiistudyofvilazodoneinpatientswithgeneralizedanxietydisorder
AT thasemichaele doubleblindrandomizedplacebocontrolledfixeddosephaseiiistudyofvilazodoneinpatientswithgeneralizedanxietydisorder