A new study shows that people living with Major Depressive Disorder (MDD) and comorbid Generalized Anxiety Disorder (GAD) benefit from treatment with vortioxetine as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS). Patients included in the study had a primary diagnosis of MDD and a diagnosis of comorbid GAD. These patients represent one of the largest subpopulations of patients with MDD.
H. Lundbeck A/S (Lundbeck) announces positive data showing that Trintellix/Brintellix® (vortioxetine) helps people living with Major Depressive Disorder and Generalized Anxiety Disorder as a co-morbidity. The study, which is called RECONNECT, was carried out from the end of 2019 and finished March 2021.
A significant improvement in symptoms of depression as measured by Montgomery-Åsberg Depression Rating Scale (MADRS) was observed with a decrease of 16.85 points from baseline. The MADRS total score has a range of 0-60, with higher scores indicating greater severity, and a decrease of 16.85 is considered clinically meaningful. There was also a significant improvement in anxiety symptoms, with a decrease of 16.05 points from baseline as measured by the Hamilton Anxiety Rating Scale (HAM-A). HAM-A has a range from 0-56, with higher scores indicating greater severity, and a decrease of 16.05 is seen as a clinically meaningful improvement.
"We are very pleased to be able to share such positive data on the effects of vortioxetine in people diagnosed with both MDD and GAD, a highly comorbid condition. The observed improvements on functional readouts following vortioxetine treatment are particularly encouraging, since patients with MDD and comorbid GAD are well-recognized to have poor overall functioning, including patients' social, family and work life," says Johan Luthman, Executive Vice President, Research and Development at Lundbeck.
Improvement in depressive and anxiety symptoms in the study population was strongly and significantly correlated with improvement in patients overall functioning, as measured by the clinician-rated Functioning Assessment Short Test (FAST), and health-related quality of life, as measured by the Quality of Life Enjoyment and Satisfaction Questionnaire long form (Q-LES-Q). Safety and tolerability data reported in the study were consistent with data from the pivotal development program of vortioxetine, confirming the tolerability profile of the compound.
In total, 100 patients were enrolled in the study. The patients had a primary diagnosis of MDD and comorbid diagnosis of GAD (made prior to their current event depressive episode).
At study entry the patients were severely depressed (average MADRS total score at baseline 30 points) and anxious (average HAM-A total score at baseline 29 points). Patients were treated open-label with flexible doses of 10 and 20 mg vortioxetine. A forced up-titration to 20 mg vortioxetine was scheduled after 1 week of treatment with 10 mg. The study was conducted in France, Spain, Italy, South Korea, and Poland. Seventy-seven percent of the patients had already failed another antidepressant before enrolling in the study.
Patients with MDD and comorbid GAD is a patient population that is more difficult to treat than patients with a singular diagnosis of MDD or GAD.[i] This means longer treatment duration, higher risk of withdrawal from treatment, and poorer remission rates. Patients who have depression and comorbid anxiety also have higher severity of illness, higher chronicity, and significantly greater impairment in work functioning, psychosocial functioning, and quality of life than patients not suffering from comorbidity[ii].
The results of the study will be presented at ECNP's (The European College of Neuropsychopharmacology) yearly congress in October in Lisbon this year and is intended to be published in a peer-reviewed scientific journal during 2021/2022.
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The study was an 8-week interventional, open-label effectiveness study of flexible doses of vortioxetine (10 and 20 mg) with a primary objective to investigate the effect on depressive symptoms in patients with MDD comorbid with GAD. The primary outcome was change from baseline to week 8 in MADRS total score. Key secondary endpoints in the study included change from baseline to week 8 in HAM-A total score, Functioning Assessment Short Test (FAST), and Q-LES-Q.
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. Vortioxetine 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®.
H. Lundbeck A/S (LUN.CO, LUN DC, HLUYY) is a global pharmaceutical company specialized in brain diseases. For more than 70 years, we have been at the forefront of neuroscience research. We are tirelessly dedicated to restoring brain health, so every person can be their best.
Millions of people worldwide live with brain diseases and far too many suffer due to inadequate treatment, discrimination, a reduced number of working days, early retirement and other unnecessary consequences. Every day, we strive for improved treatment and a better life for people living with brain diseases - we call this Progress in Mind.
Our approximately 5,600 employees in more than 50 countries are engaged in the entire value chain throughout research, development, production, marketing and sales. Our pipeline consists of several R&D programs and our products are available in more than 100 countries. We have research centers in Denmark and the US, and our production facilities are located in Denmark, France and Italy. Lundbeck generated revenue of DKK 17.7 billion in 2020 (EUR 2.4 billion; USD 2.7 billion).
For additional information, we encourage you to visit our corporate site www.lundbeck.com and connect with us on Twitter at @Lundbeck and via LinkedIn.
[i] Kessler RC, DuPont RL, Berglund P, Wittchen HU. Impairment in pure and comorbid generalized anxiety disorder and major depression at 12 months in two national surveys. Am J Psychiatry. 1999; 156: 1915-1923.
[ii] Hirschfeld RM. The Comorbidity of Major Depression and Anxiety Disorders: Recognition and Management in Primary Care. Prim Care Companion J Clin Psychiatry. 2001; Dec;3(6): 244-254.
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