These tools will no longer be maintained as of December 31, 2024. Archived website can be found here. PubMed4Hh GitHub repository can be found here. Contact NLM Customer Service if you have questions.


Pubmed for Handhelds

PUBMED FOR HANDHELDS

Search MEDLINE/PubMed

  • Title: Comparison of vortioxetine versus venlafaxine XR in adults in Asia with major depressive disorder: a randomized, double-blind study.
    Author: Wang G, Gislum M, Filippov G, Montgomery S.
    Journal: Curr Med Res Opin; 2015 Apr; 31(4):785-94. PubMed ID: 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 AND METHODS: 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 (1:1) 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.
    [Abstract] [Full Text] [Related] [New Search]