A randomized, double-blind, fixed-dose study comparing the efficacy and tolerability of vortioxetine 2.5 and 10 mg in acute treatment of adults with generalized anxiety disorder.
Hum Psychopharmacol
; 29(1): 64-72, 2014 Jan.
Article
em En
| MEDLINE
| ID: mdl-24424707
ABSTRACT
BACKGROUND:
Vortioxetine is a recently approved multimodal antidepressant with anxiolytic properties in preclinical studies.OBJECTIVE:
This double-blind, placebo-controlled study assessed the efficacy and tolerability of vortioxetine in subjects with a primary diagnosis of generalized anxiety disorder.METHODS:
Subjects (n = 457) were randomized 111 to treatment with placebo or vortioxetine 2.5 or 10 mg once daily. The primary efficacy endpoint was reduction in Hamilton Anxiety Scale (HAM-A) total scores from baseline after 8 weeks of treatment. Key secondary outcomes were changes from baseline in HAM-A total scores for the 2.5 and 10 mg dose, Hospital Anxiety and Depression anxiety subscore, 36-Item Short-Form Health Survey, Sheehan Disability Scale, and Clinical Global Impression-Improvement Scale score, as well as HAM-A response rate at week 8.RESULTS:
Neither vortioxetine dose achieved a statistically significant improvement over placebo on the primary endpoint (least-squares mean difference ± standard error from placebo -0.87 ± 0.803 [p = 0.279] for 2.5 mg and -0.81 ± 0.791 [p = 0.306] for 10 mg vortioxetine) or on any secondary efficacy endpoints. Common adverse events (≥5% in either vortioxetine group) were nausea, dry mouth, headache, diarrhea, constipation, and vomiting.CONCLUSIONS:
Vortioxetine 2.5 and 10 mg treatment did not significantly improve generalized anxiety disorder symptoms versus placebo. Vortioxetine was safe and well tolerated in this patient population.Palavras-chave
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Base de dados:
MEDLINE
Assunto principal:
Transtornos de Ansiedade
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Piperazinas
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Sulfetos
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Ansiolíticos
Idioma:
En
Ano de publicação:
2014
Tipo de documento:
Article