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New results from Lundbeck’s vortioxetine trial

Johan Luthman

Lundbeck recently completed a global Phase IV, randomized, comparative study exploring the role of vortioxetine as a treatment option between SSRIs and serotonin–noradrenaline reuptake inhibitors (SNRIs).

The efficacy of vortioxetine was directly compared to one of the latest introduced SNRIs, desvenlafaxine, as monotherapy. The study, called VIVRE, recruited a total of 605 patients across 12 countries at sites in Europe and South America who were suffering from MDD and had a partial response to treatment with an SSRI for at least 6 weeks at approved dose. The VIVRE study took place from mid-2020 to early 2022 and is one of the rare examples of Phase IV head-to-head studies in MDD.

“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 Johan Luthman, Executive Vice President for Research and Development at Lundbeck.

The VIVRE study

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 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 Short Test (FAST), which is a physician-rated scale assessing the main functioning problems experienced by patients.

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.

Photo of Johan Luthman: Lundbeck