Vortioxetine Enhances Cognition, Particularly in Patients of Normal Weight: Presented at APA

By Louise Gagnon

TORONTO -- May 22, 2015 -- Patients with cognitive dysfunction and major depressive disorder have improved cognition while on vortioxetine, according to a study presented here at the 168th Annual Meeting of the American Psychiatric Association (APA).

Cognitive dysfunction has come to be recognized as common in major depressive disorder, which is leading to a search for therapies that treat depression along with cognitive deficits, said Soren Lophaven, PhD, H. Lundbeck A/S, Copenhagen, Denmark, on May 19.

“Cognitive assessment was the primary objective,” said Dr. Lophaven.

Apart from comparing the drug to placebo in the overall study population, the investigators also performed a subgroup analysis to evaluate whether factors such as age, sex, education level, and body mass index (BMI) influence response to therapy.

Patients in the study were randomised to receive vortioxetine 10 or 20 mg/day or placebo.

Improvements in cognition were measured with the Digit Symbol Substitution Test (DSST). Statistically significant differences in DSST results were found between both doses of active therapy and placebo.

In the subgroup analysis, age did not influence the efficacy of the medications. Both doses were significantly superior in patients aged ≤50 years and those aged>50 years. Sex also did not influence the efficacy of the medication, with both doses of vortioxetine being significantly superior than placebo in men and women. Similar effects of both doses of the drug were seen regardless of educational level.

Weight, however, did influence the impact of the medication. Both doses were significantly superior in patients who had a BMI of <25 kg/m2 (n = 233). For patients considered overweight (BMI ≥25 but <30 kg/m2; n = 202), the higher dose of the medication was significantly superior. For obese patients (BMI ≥30; n =156), vortioxetine was not significantly superior to placebo at either dose.

“The effect seems to decline with higher BMI,” said Dr. Lophaven, noting that the subgroup of patients with a BMI of ≥30 was smaller than the other BMI subgroups.

“The overall message is that the drug works across various groups of patients,” said Dr. Lophaven. “Some groups see a greater impact than other groups.”

Funding for the study was provided by H. Lundbeck A/S as part of a joint clinical development program with Takeda Pharmaceutical Company, Ltd.

[Presentation title: Effect of Vortioxetine on Cognitive Dysfunction in Subgroups of Adult MDD Patients: A Randomized, Double-Blind, Placebo-Controlled Study. Abstract P8-055]

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