- The study assessed the efficacy of vortioxetine in a head-to-head comparison to desvenlafaxine in patients suffering from Major Depressive Disorder (MDD) who had a partial response to selective serotonin reuptake inhibitors (SSRI) treatment.
- The primary study objective was achieved by demonstrating non-inferiority of vortioxetine to desvenlafaxine on depression symptom reduction (MADRS).
- On secondary endpoints, vortioxetine-treated patients were significantly more likely to reach global clinical remission (CGI-S), experience a significant improvement in their daily and social functioning (FAST), as well as experience significant effect on treatment satisfaction compared to desvenlafaxine as measured by Q-LES-Q.
Vortioxetine demonstrated non-inferiority to desvenlafaxine on the primary study endpoint as measured by Montgomery-Åsberg Depression Rating Scale (MADRS) with a treatment difference of -0,47 on the MADRS total score (confidence limit [-1.61, 0.67]) in favor of vortioxetine, meeting a predefined non-inferiority criterion.
Importantly, the VIVRE study demonstrated that vortioxetine provided significant benefits vs desvenlafaxine in the secondary endpoints including remission, daily and social functioning, and satisfaction with medication.
A significantly higher percentage of vortioxetine treated patients were in remission (33% versus 25% for desvenlafaxine, p-value 0.0339) at the end of the study, as measured by the Clinical Global Impression rating for the Severity of Illness (CGI-S) scale. The CGI rating measures the decrease in the severity of depressive symptoms as they relate to patient´s functioning.
This is highly relevant as the VIVRE study identified two domains of overall functioning in which vortioxetine treated patients showed significantly better outcome - daily functioning (also known as autonomy) and social functioning (or interpersonal skills) versus patients treated with desvenlafaxine (p-value 0.0092 and 0.0448, respectively). These results were obtained using the Functioning Assessment
Finally, in these patients with partial response to prior SSRI therapy the average treatment satisfaction at baseline was 40.2%. Employing the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q), the study revealed that patients who received vortioxetine reported a significant increase in the Satisfaction with Medication compared to patients treated with desvenlafaxine (27% vs 24% respectively, p-value 0.0438).
On other study outcomes, vortioxetine showed advantage or comparable effects to desvenlafaxine.
Overall, the study was confirming the previously reported tolerability profiles for vortioxetine and desvenlafaxine.
"This study clearly demonstrates that a vulnerable patient subpopulation, namely patients suffering from MDD, but only partially responsive to SSRIs, are offered important clinical benefits when treated with Trintellix/Brintellix® (vortioxetine) compared to SNRI treatment. Using objective assessments, the secondary endpoints in the study show a significantly better efficacy of Trintellix/Brintellix® versus desvenlafaxine on remission, as well as daily and social functioning says
The results of the study will be presented at
Contacts
Veneta Gerganova | |
Media Relations Specialist, Corp. Communication | Vice President, Investor Relations |
VEGE@lundbeck.com | PALO@lundbeck.com |
+45 30 83 33 31 | +45 30 83 24 26 |
About the VIVRE study
VIVRE was a global phase IV head-to-head randomized comparative study evaluating the efficacy of vortioxetine versus desvenlafaxine on depressive symptoms, rewards motivation, cognitive performance, and health-related quality of life (HRQoL) in patients with MDD with a partial response to SSRIs treatment in a psychiatric outpatient setting. The study enrolled a total of 605 patients (f/m, aged 18-65 years) at sites in
About vortioxetine
The mechanism of the antidepressant effect of vortioxetine is not fully understood. It is an inhibitor of serotonin (5-HT) reuptake and that is thought to be a mechanism of its action. It is also an agonist at 5-HT1A receptors, a partial agonist at 5-HT1B receptors and an antagonist at 5-HT3, 5-HT1D and 5-HT7 receptors. The contribution of each of these activities to vortioxetine's antidepressant effect has not been established. It is considered to be the first and only compound with this combination of pharmacodynamic activity. The clinical relevance of this is not fully understood. Vortioxetine was discovered by Lundbeck researchers in
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