Date: 2014-12-11
Type of information: Presentation of results at a congress
phase:
Announcement: presentation of results at the 53rd Annual Meeting of the American College of Neuropsychopharmacology (ACNP) December 7—11 2014, Phoenix, Arizona
Company: Lundbeck (Denmark)
Product: Brintellix® (vortioxetine)
Action
mechanism: serotonin receptor agonist/serotonin receptor antagonist. Brintellix® is an inhibitor of serotonin (5-HT) reuptake and 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. Vortioxetine was discovered by Lundbeck researchers in Copenhagen, Denmark. The clinical trial program in the U.S. was conducted jointly by Lundbeck and Takeda, and Takeda holds marketing authorization for the U.S. market. Brintellix® is a trademark of H. Lundbeck A/S and is used under license by Takeda Pharmaceuticals America.
Disease: major depressive disorder
Therapeutic area: CNS diseases - Mental diseases
Country: UK
Trial
details: Forty-eight persons remitted from depression (HAM-D17 ≤7) who reported subjective cognitive difficulties and who had received no treatment for at least 6 weeks and forty-eight healthy never-depressed controls participated in a 4-armed, multi-site, placebo-controlled, randomized, double-blind trial in the United Kingdom. In the fMRI study, subjects were treated with once daily doses of vortioxetine (20 mg) or placebo for 12 — 13 consecutive days. Resting-state and task-related functional magnetic resonance imaging (fMRI) was assessed in a 3T magnetic resonance scanner during a baseline visit (pre-treatment), and again after 12-13 days of treatment (post-treatment).
Latest
news: * On December 11, 2014, Lundbeck announced poster presentations at the 53rd Annual Meeting of the American College of Neuropsychopharmacology (ACNP) December 7—11 2014, Phoenix, Arizona. The findings show Brintellix® (vortioxetine) increases neural efficiency compared to placebo during a working memory challenge. New pharmacological data from people previously suffering from major depressive disorder demonstrated that Brintellix® increases neural efficiency during a working memory challenge, according to imaging (functional magnetic resonance imaging or fMRI is a technique for measuring and mapping brain activity) data. Lundbeck has undertaken this pharmacological study to investigate the influence of Brintellix® on cognitive performance and its effects on brain activity during resting state in people remitted from depression and a never-depressed control group.
Normalization of brain activity
Previous studies have demonstrated that people suffering from depression over-activate their brain (neural) systems in order to perform on cognitive tasks. The present findings suggest that Brintellix® may be able to normalize such over-activity (improve neural efficiency) within neural circuits important for executive function and working memory. For the people remitted from depression who received Brintellix®, less effort was required (as measured by brain activity) to perform at the same level on cognitive tasks compared to the control group, who received placebo.
During resting state, Brintellix® was also found to alter brain activity in the opposite direction (normalizing) to that found in people with acute depression. Abnormal resting-state activity in brain regions involving the so-called default mode network has been linked to the cognitive dysfunction characteristic of depression.
The default mode network is typically active when the mind wanders and is not active when an individual engages in a focused activity. Researchers have found the network is active in people who are depressed, even when they are concentrating on specific tasks.
The findings of this fMRI study show a reversal of the changes in brain activity previously reported in people with depression, and suggest that Brintellix® may be able to normalize over-activity (improve neural efficiency) within neural circuits important for executive function in depression as well as normalizing brain activity during resting state.
(Effects of vortioxetine on resting-state activity in subjects remitted from depression and healthy controls - Abstract M155 and Vortioxetine Reduces BOLD Signal during Performance of the N-Back Task in Subjects Remitted from Depression and Healthy Control Participants - Abstract W12)
