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Post Hoc Analyses of Anxiety Measures in Adult Patients With Generalized Anxiety Disorder Treated With Vilazodone
OBJECTIVE: To investigate vilazodone, currently approved for major depressive disorder in adults, for generalized anxiety disorder (GAD). METHOD: Three randomized, double-blind, placebo-controlled studies showing positive results for vilazodone (2,040 mg/d) in adult patients with GAD (DSM-IV-TR) wer...
Autores principales: | , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Physicians Postgraduate Press, Inc.
2016
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4956429/ https://www.ncbi.nlm.nih.gov/pubmed/27486544 http://dx.doi.org/10.4088/PCC.15m01904 |
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author | Khan, Arif Durgam, Suresh Tang, Xiongwen Ruth, Adam Mathews, Maju Gommoll, Carl P. |
author_facet | Khan, Arif Durgam, Suresh Tang, Xiongwen Ruth, Adam Mathews, Maju Gommoll, Carl P. |
author_sort | Khan, Arif |
collection | PubMed |
description | OBJECTIVE: To investigate vilazodone, currently approved for major depressive disorder in adults, for generalized anxiety disorder (GAD). METHOD: Three randomized, double-blind, placebo-controlled studies showing positive results for vilazodone (2,040 mg/d) in adult patients with GAD (DSM-IV-TR) were pooled for analyses; data were collected from June 2012 to March 2014. Post hoc outcomes in the pooled intent-to-treat population (n = 1,462) included mean change from baseline to week 8 in Hamilton Anxiety Rating Scale (HARS) total score, psychic and somatic anxiety subscale scores, and individual item scores; HARS response (≥ 50% total score improvement) and remission (total score ≤ 7) at week 8; and category shifts, defined as HARS item score ≥ 2 at baseline (moderate to very severe symptoms) and score of 0 at week 8 (no symptoms). RESULTS: The least squares mean difference was statistically significant for vilazodone versus placebo in change from baseline to week 8 in HARS total score (−1.83, P < .0001) and in psychic anxiety (−1.21, P < .0001) and somatic anxiety (−0.63, P < .01) subscale scores; differences from placebo were significant on 11 of 14 HARS items (P < .05). Response rates were higher with vilazodone than placebo (48% vs 39%, P < .001), as were remission rates (27% vs 21%, P < .01). The percentage of patients who shifted to no symptoms was significant for vilazodone on several items: anxious mood, tension, intellectual, depressed mood, somatic-muscular, somatic-sensory, cardiovascular, respiratory, and autonomic symptoms (P < .05). CONCLUSIONS: Treatment with vilazodone versus placebo was effective in adult GAD patients, with significant differences between treatment groups found on both psychic and somatic HARS items. TRIAL REGISTRATION: ClinicalTrials.gov identifiers: NCT01629966, NCT01766401, NCT01844115. |
format | Online Article Text |
id | pubmed-4956429 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2016 |
publisher | Physicians Postgraduate Press, Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-49564292016-08-02 Post Hoc Analyses of Anxiety Measures in Adult Patients With Generalized Anxiety Disorder Treated With Vilazodone Khan, Arif Durgam, Suresh Tang, Xiongwen Ruth, Adam Mathews, Maju Gommoll, Carl P. Prim Care Companion CNS Disord Articles OBJECTIVE: To investigate vilazodone, currently approved for major depressive disorder in adults, for generalized anxiety disorder (GAD). METHOD: Three randomized, double-blind, placebo-controlled studies showing positive results for vilazodone (2,040 mg/d) in adult patients with GAD (DSM-IV-TR) were pooled for analyses; data were collected from June 2012 to March 2014. Post hoc outcomes in the pooled intent-to-treat population (n = 1,462) included mean change from baseline to week 8 in Hamilton Anxiety Rating Scale (HARS) total score, psychic and somatic anxiety subscale scores, and individual item scores; HARS response (≥ 50% total score improvement) and remission (total score ≤ 7) at week 8; and category shifts, defined as HARS item score ≥ 2 at baseline (moderate to very severe symptoms) and score of 0 at week 8 (no symptoms). RESULTS: The least squares mean difference was statistically significant for vilazodone versus placebo in change from baseline to week 8 in HARS total score (−1.83, P < .0001) and in psychic anxiety (−1.21, P < .0001) and somatic anxiety (−0.63, P < .01) subscale scores; differences from placebo were significant on 11 of 14 HARS items (P < .05). Response rates were higher with vilazodone than placebo (48% vs 39%, P < .001), as were remission rates (27% vs 21%, P < .01). The percentage of patients who shifted to no symptoms was significant for vilazodone on several items: anxious mood, tension, intellectual, depressed mood, somatic-muscular, somatic-sensory, cardiovascular, respiratory, and autonomic symptoms (P < .05). CONCLUSIONS: Treatment with vilazodone versus placebo was effective in adult GAD patients, with significant differences between treatment groups found on both psychic and somatic HARS items. TRIAL REGISTRATION: ClinicalTrials.gov identifiers: NCT01629966, NCT01766401, NCT01844115. Physicians Postgraduate Press, Inc. 2016-04-28 /pmc/articles/PMC4956429/ /pubmed/27486544 http://dx.doi.org/10.4088/PCC.15m01904 Text en Copyright © 2016, Physicians Postgraduate Press, Inc. Open Access Article |
spellingShingle | Articles Khan, Arif Durgam, Suresh Tang, Xiongwen Ruth, Adam Mathews, Maju Gommoll, Carl P. Post Hoc Analyses of Anxiety Measures in Adult Patients With Generalized Anxiety Disorder Treated With Vilazodone |
title | Post Hoc Analyses of Anxiety Measures in Adult Patients With Generalized Anxiety Disorder Treated With Vilazodone |
title_full | Post Hoc Analyses of Anxiety Measures in Adult Patients With Generalized Anxiety Disorder Treated With Vilazodone |
title_fullStr | Post Hoc Analyses of Anxiety Measures in Adult Patients With Generalized Anxiety Disorder Treated With Vilazodone |
title_full_unstemmed | Post Hoc Analyses of Anxiety Measures in Adult Patients With Generalized Anxiety Disorder Treated With Vilazodone |
title_short | Post Hoc Analyses of Anxiety Measures in Adult Patients With Generalized Anxiety Disorder Treated With Vilazodone |
title_sort | post hoc analyses of anxiety measures in adult patients with generalized anxiety disorder treated with vilazodone |
topic | Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4956429/ https://www.ncbi.nlm.nih.gov/pubmed/27486544 http://dx.doi.org/10.4088/PCC.15m01904 |
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