A 12-week course of vortioxetine can improve cognition, overall functioning, and quality of life in older patients with major depressive disorder (MDD) and comorbid early-stage dementia, according to study findings published in the Journal of Affective Disorders.
Depression and dementia are common in older adults and can often present as comorbid conditions. Vortioxetine is an antidepressant that has shown to improve cognitive performance and quality of life in patients with MDD.
Researchers conducted MEMORY (ClinicalTrials.gov Identifier: NCT04294654), a multicenter, open-label effectiveness Phase IV study, to assess the effectiveness of vortioxetine in improving mood and cognition in patients with MDD and early-stage dementia.
The study included 16 psychiatric sites from 5 countries: Estonia, France, Italy, Poland and Spain. Data was collected from February 2020 through July 2022.
The stages of this study were a 2-week screening period, a 12-week open-label flexible dose treatment period, and a 4 week-safety follow up period or study withdrawal.
The researchers included patients aged 55 to 85 with a recurrent MDD diagnosis and documented early-stage dementia diagnosed at least 6 months before screening and after the onset of MDD. The researchers also required patients to have an MDD onset before the age of 55 and the patients included had to be experiencing a current depressive episode less than 6 months in duration.
Patients taking other antidepressant medications other than vortioxetine were excluded from the study. Other patients excluded from treatment were those with a vitamin B12 or folate deficiency, those who had a significant suicide risk, and those who had a different psychiatric disorder aside from dementia.
The primary endpoint was a change in Montgomery-Åsberg Depression Rating Scale (MADRS) from baseline to week 12.
A total of 82 patients aged 55 to 85 (mean age, 70.3) were included in the study. Over half of participants were women (66%) and most patients were White (95%). The average duration of the current depressive episode was 12.5 weeks.
There was a significant improvement in the MADRS total score observed for patients at all study periods (P <.0001). The least-squares average change in MADRS score from baseline was -12.4 (standard error [SE], 0.78) at week 12.
Cognitive performance was improved among patients as shown by the DSST total score change from baseline (4.9; SE, 0.9; P <.0001).
There were also significant improvements in daily function, which was assessed by the IADL polytomous score at week 12 (-0.86; P =.009).
The researchers observed significant improvements in health-related quality of life (HRQoL) from baseline to week 12, with a least-squares mean percentage BASQID total score of 10.2 (SE, 1.25). Overall disease severity and impact on global functioning showed improvements at week 4 and 12 (P <.0001 for both).
“It is likely that the procognitive effects of vortioxetine will be most marked in patients with dementia when used early in the course of the disease, before significant irreversible damage to signal firing capacity and neurotransmitter function has occurred,” the researchers wrote.
Study limitations included the lack of a control population and its open-label design.
Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Christensen MC, Schmidt SN, Grande I. Effectiveness of vortioxetine in patients with major depressive disorder and early-stage dementia: the MEMORY study. J Affect Disord. Published online June 12, 2023. doi:10.1016/j.jad.2023.06.024