Comparison of vortioxetine versus venlafaxine XR in adults in Asia with major depressive disorder: a randomized, double-blind study.
Curr Med Res Opin
; 31(4): 785-94, 2015 Apr.
Article
em En
| MEDLINE
| ID: mdl-25650503
ABSTRACT
OBJECTIVE:
This randomized, double-blind 8 week study compared the efficacy and tolerability of fixed-dose treatment with vortioxetine (10 mg/day) and venlafaxine extended release (XR) (150 mg/day) in major depressive disorder (MDD) patients. RESEARCH DESIGN ANDMETHODS:
Patients aged 18-65 years with a primary diagnosis of recurrent MDD, a Montgomery-Åsberg Depression Rating Scale (MADRS) total score ≥26 and a Clinical Global Impression-Severity (CGI-S) score ≥4 were randomized (11) to treatment with either vortioxetine or venlafaxine XR. The primary endpoint was change from baseline to Week 8 in MADRS total score (analysis of covariance [ANCOVA], full-analysis set [FAS], last observation carried forward [LOCF]), using a non-inferiority margin of +2.5 points. Pre-specified secondary endpoints included MADRS response and remission rates, anxiety symptoms (HAM-A), CGI, overall functioning (SDS), and health-related quality of life (Q-LES-Q). CLINICAL TRIAL REGISTRATION This study (SOLUTION) has the www.ClinicalTrials.gov identifier NCT01571453.RESULTS:
On the primary efficacy endpoint at Week 8, non-inferiority was established with a difference of -1.2 MADRS points in favor of vortioxetine (95% CI -3.0 to 0.6). The MADRS total score decreased (improved) from 32.3 ± 4.6 at baseline to 13.6 ± 9.6 (vortioxetine n = 209) and from 32.3 ± 4.5 to 14.8 ± 10.4 (venlafaxine XR n = 215) (FAS, LOCF). At Week 8, the HAM-A and SDS total scores, CGI and Q-LES-Q scores, and response and remission rates demonstrated similar improvement for vortioxetine and venlafaxine XR, with remission rates (MADRS ≤10) of 43.1% (vortioxetine) versus 41.4% (venlafaxine XR) (LOCF). Fewer vortioxetine than venlafaxine XR patients withdrew for any reason (18.0% versus 27.4%) or for adverse events (6.6% versus 13.7%). The most frequent adverse events (≥5%) for both treatments were nausea, dizziness, headache, and dry mouth. In addition, accidental overdose, decreased appetite, constipation and insomnia were reported by (≥5%) of patients treated with venlafaxine XR.LIMITATIONS:
The inclusion and exclusion criteria may limit the generalizability of the study. Since patients with a history of lack of response to venlafaxine XR were excluded from this study, there is a selection bias in favor of venlafaxine XR.CONCLUSION:
Vortioxetine was at least as efficacious as venlafaxine XR and was safe and better tolerated than venlafaxine XR.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Piperazinas
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Sulfetos
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Inibidores Seletivos de Recaptação de Serotonina
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Cicloexanóis
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Transtorno Depressivo Maior
Tipo de estudo:
Clinical_trials
/
Prognostic_studies
Limite:
Adolescent
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Adult
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Aged
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Female
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Humans
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Male
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Middle aged
País/Região como assunto:
Asia
Idioma:
En
Revista:
Curr Med Res Opin
Ano de publicação:
2015
Tipo de documento:
Article
País de afiliação:
China