H. Lundbeck A/S (Lundbeck) has announced positive results for the REVIVE study, a double-blind randomised 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 (10-20mg/day) versus agomelatine (25-50mg/day) in this challenging MDD patient population. The study was conducted in Europe and one of the newest antidepressants agomelatine was chosen as a comparator because of its different mode of action from conventional SSRI/SNRI therapies.
Few randomised, double-blind studies comparing treatment strategies in MDD patients who were unresponsive to first-line antidepressant treatment have been conducted. This is one of these few studies which also shows a significant difference between treatments.
“Patients with inadequate response to current SSRI or SNRI therapies represent a large proportion of patients suffering from major depression. Only a few years ago, the landmark STAR*D study1 confirmed a significant unmet medical need as only half of patients responded to their first-line treatment, which was an SSRI. First-line treatments in clinical practice are typically SSRIs or SNRIs,” says Executive Vice President Anders Gersel Pedersen, Head of Research & Development at Lundbeck.
In the REVIVE study, the primary efficacy endpoint was change from baseline to week 8 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 randomised to Brintellix (10-20mg/day) or agomelatine (25-50mg/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 favour 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%). Adverse events were consistent with results from previous clinical phase III studies and included nausea (Brintellix 16% and agomelatine 9%) (incidence >5% and higher than agomelatine). Overall, this study confirms that Brintellix is efficacious and well tolerated.
Separately, Lundbeck plans to present further efficacy and safety data from its pivotal clinical programme at the 166th American Psychiatric Association (APA) Annual Meeting in San Francisco, USA, 18-22 May 2013.