The effect of vortioxetine on overall patient functioning in patients with major depressive disorder.
Brain Behav
; 7(3): e00622, 2017 03.
Article
em En
| MEDLINE
| ID: mdl-28293465
ABSTRACT
BACKGROUND:
The objectives of this meta-analysis of data from randomized, placebo-controlled studies were to assess the effect of vortioxetine on overall functioning (primary) and functional remission (secondary) using the Sheehan Disability Scale (SDS) in adults with major depressive disorder (MDD).METHODS:
Data from nine short-term (6/8 weeks) pivotal studies that included patient functioning assessments were included in this random-effects meta-analysis, which used aggregated study-level data for all therapeutic vortioxetine doses and a mixed-effect model for repeated measures using the full analysis set.RESULTS:
A total of 4,216 patients received ≥1 dose of study treatment (1,522 placebo, 2,694 vortioxetine 5-20 mg/day). At study end, the meta-analysis showed improvement for vortioxetine versus placebo (n = 911) in SDS total score (vortioxetine 5 mg, n = 564, change from baseline versus placebo [Δ] -0.24, p = NS; 10 mg, n = 445, Δ -1.68, p ≤ .001; 15 mg, n = 204, Δ -0.91, p = NS; 20 mg, n = 340, Δ -1.94, p ≤ .01). Functional remission (SDS total score ≤6) was observed with vortioxetine 10 mg (n = 170/573; odds ratio [OR] relative to placebo 1.7, p < .001) and 20 mg (n = 144/447; OR 1.6, p < .05), but not 5 mg (n = 207/757; OR 1.1, p = NS) or 15 mg (n = 92/295; OR 1.3, p = NS).CONCLUSION:
Vortioxetine 5-20 mg for 6/8 weeks improved overall patient functioning in patients with MDD. Relative to placebo, vortioxetine 10 and 20 mg demonstrated significant improvement in SDS total score and functional remission.Palavras-chave
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Piperazinas
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Sulfetos
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Ensaios Clínicos Controlados Aleatórios como Assunto
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Avaliação de Resultados em Cuidados de Saúde
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Inibidores Seletivos de Recaptação de Serotonina
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Transtorno Depressivo Maior
Tipo de estudo:
Clinical_trials
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Prognostic_studies
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Systematic_reviews
Limite:
Adult
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Revista:
Brain Behav
Ano de publicação:
2017
Tipo de documento:
Article