Lundbeck presents positive data from the COMPLETE study with vortioxetine

H. Lundbeck A/S (Lundbeck) announces a new study that finds reduction in emotional blunting for people living with Major Depressive Disorder when treated with vortioxetine. In total, 150 patients were enrolled in the study called COMPLETE. A significant improvement in symptoms of emotional blunting as measured by Oxford Depression Questionnaire (ODQ) was observed after only one week of treatment; a benefit that continued to increase up until the end of study.

Emotional blunting is a common symptom of MDD and is clinically important as it prevents full recovery. It is experienced by half of all patients treated with SSRIs (Selective Serotonin Reuptake Inhibitors) or SNRIs (Serotonin–Norepinephrine Reuptake Inhibitor).

“Blunted emotions are well-recognized to have functional consequences on patients’ social, family and work life. It is a severe symptom to people who are seeking full recovery from Major Depressive Disorder. We are pleased to be able to share such positive data with the wider neuroscience community,” says Johan Luthman, EVP Research and Development

Patients in the study had been treated at adequate dose for at least six weeks with either an SSRI or SNRI and suffered from emotional blunting prior to entering this 8-week open-label study. After eight weeks of treatment with vortioxetine, 50% of the patients reported they did not experience this symptom anymore. A significant improvement in patients psychosocial functioning as measured by the Sheehan Disability Scale (work, family and social life) was also observed.

Based on the mechanism of actions, in particular modulation of 5-HT3 and the downstream positive effect on dopamine, the results of this study appear to support that vortioxetine may have a positive effect on emotional blunting.The results are encouraging as they show that emotional blunting potentially can be addressed by switching medication and lead to a significant improvement in their overall functioning in daily life. 

The key data from the study was presented on the occasion of the 33rd ECNP Congress Virtual with educational financial support provided by Lundbeck.

About emotional blunting
About 50% of all patients treated with SSRIs or SNRIs suffer from emotional blunting[i]. This symptom is a clinical state where both positive and negative emotions are toned down or flattened. It leaves patients feeling indifferent to many aspects of their life that should matter to them such as their family, friends, and their job. The symptoms are particularly prominent when patients reach remission from their core symptoms of depression and re-engage in activities of their normal life that have been reduced or put on hold during the acute phase of their illness. Living with emotional blunting is unacceptable for many patients with MDD and it is a very common reason for stopping medication.

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 unknown. Vortioxetine was discovered by Lundbeck researchers in Copenhagen, Denmark. Depending on the market, vortioxetine is known as Trintellix® or Brintellix®.

Contacts
Mikkel Ballegaard Pedersen
Communication Consultant, Corp. Communication
mbap@lundbeck.com
+45 30 83 20 44

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