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-Asberg 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.
A significant improvement in symptoms of depression as measured by Montgomery-Asberg 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
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
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
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 (
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About RECONNECT
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
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. 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
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[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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