Brintellix Tackles Cognitive Dysfunction Related to Major Depression

In addition to treating episodes of major depression, Brintellix (vortioxentine) has demonstrated superiority to placebo on measures of cognitive function in adult patients with major depressive disorder (MDD), according to outcomes from a randomized, fixed-dose clinical study presented at the 52^nd Annual Meeting of the American College of Neuropsychopharmacology (ACNP), held December 8-12, 2013, in Hollywood, FL.

In September 2013, the US Food and Drug Administration (FDA) approved Brintellix as an MDD treatment after 6 clinical studies established the antidepressant’s efficacy in adults with the mood disorder. But Roger McIntyre, MD, a psychiatry and pharmacology professor at the University of Toronto, pointed out in a press release that “in addition to the emotional symptoms of major depression, people with depression may also frequently experience a range of cognitive symptoms, including an impaired ability to think, concentrate or make decisions that can affect work, school and family life.”

To determine whether Brintellix tackles those cognitive symptoms, 598 MDD patients between the ages of 18 and 65 years old were randomized to receive placebo or either 10 mg or 20 mg vortioxentine in the drug’s phase 3 FOCUS trial. According to the study results, composite scores of 2 neuropsychological tests conducted at baseline and 8 weeks showed significant improvements on “specific cognitive domains known to be impaired in major depression, including executive function, speed of processing, attention, and memory,” for both dosage forms of Brintellix compared to placebo. The improvements in cognitive performance were also revealed to “include a direct effect of Brintellix and (were) not solely due to improvement in depressive symptoms.”

Findings from the neuropsychological Digit Symbol Substitution Test and the Rey Auditory Verbal Learning Test were clinically supported by participant responses to a patient-reported outcome questionnaire, as they also showed substantial improvements in cognitive symptoms for both 10 mg and 20 mg vortioxentine.

Though McIntyre said further clinical studies are needed to confirm the FOCUS trial’s outcomes, he expressed that it’s encouraging “to have a new treatment option that may target a dimension of major depression that not only is a principal mediator of functional impairment … but also a domain so highly related to patient reported quality of life.”

Brintellix is co-marketed by Takeda Pharmaceuticals and Lundbeck, which supported the FOCUS trial.