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H Lundbeck A/S Announces Positive Results for Brintellix in Adult Patients with Major Depression and Inadequate Response to SSRI or SNRI Therapy


Monday, 8 Apr 2013 01:50am EDT 

H Lundbeck A/S announced positive results for the REVIVE study, a double-blind randomized study of Brintellix (vortioxetine) versus agomelatine in adults with major depression (MDD) who changed antidepressant treatment after an inadequate response to SSRI or SNRI treatment. In this study, the objective was to compare the efficacy and tolerability of flexible dose treatment with Brintellix (10-20 milligrams (mg)/day) versus agomelatine (25-50 mg/day) in this challenging MDD patient population. Agomelatine was chosen as a comparator because of its different mode of action from conventional SSRI/SNRI therapies. Few randomized, double-blind studies have been conducted. In the REVIVE study, the primary efficacy endpoint was change from baseline to week eight in MADRS total score. Secondary endpoints included assessments of anxiety symptoms (HAM-A), global clinical judgment (CGI-S, CGI-I) and overall functioning (SDS). Patients were randomized to Brintellix (10-20 mg/day) or agomelatine (25-50 mg/day) for 12 week of double-blind treatment. On the primary efficacy endpoint, Brintellix (n=252) was statistically significantly superior to agomelatine (n=241) (p<0.05) by 2.2 MADRS points. Significant differences in favor of Brintellix were also found for MADRS, HAM-A, CGI-S, CGI-I and SDS from week 4 onwards (p<0.05). Brintellix was well tolerated, with fewer patient withdrawals in the Brintellix group (5.9%) vs. agomelatine (9.5%). 

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