vortioxetine and Dementia

Depression and dementia are highly prevalent in older adults and often co-occur. This Phase IV study investigated the effectiveness and tolerability of vortioxetine in improving depressive symptoms, cognitive performance, daily and global functioning and health-related quality of life (HRQoL) in patients with major depressive disorder (MDD) and comorbid early-stage dementia.. Patients (n = 82) aged 55-85 years with a primary diagnosis of MDD (onset before age 55 years) and comorbid early-stage dementia (diagnosed ≥6 months before screening and after onset of MDD; Mini-Mental State Examination-2 total score, 20-24) received vortioxetine for 12 weeks (initiated at 5 mg/day and up-titrated to 10 mg/day at day 8, with flexible dosing thereafter [5-20 mg/day]). The primary endpoint was change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score at week 12.. Significant improvement in depressive symptom severity was seen from week 1 onwards (P < 0.0001). At week 12, the least-square mean (standard error) change in MADRS total score from baseline was -12.4 (0.78). Significant improvements in cognitive performance were observed (from week 1 for the Digit Symbol Substitution Test and week 4 for the Rey Auditory Verbal Learning Test). Patients also experienced significant improvements in daily and global functioning, and HRQoL. Vortioxetine was well tolerated. From week 4 onwards, more than 50 % of patients were receiving 20 mg/day.. Open-label study.. Vortioxetine demonstrated effectiveness in clinically significantly improving depressive symptoms, cognitive performance, daily and global functioning, and HRQoL in patients with MDD and comorbid early-stage dementia treated for 12 weeks.. ClinicalTrials.gov/ct2/show/NCT04294654.

Topics: Aged; Dementia; Depressive Disorder, Major; Double-Blind Method; Humans; Piperazines; Quality of Life; Sulfides; Treatment Outcome; Vortioxetine

Topics: Animals; Antidepressive Agents; Anxiety Disorders; Attention Deficit Disorder with Hyperactivity; Autistic Disorder; Benzodiazepines; Cognitive Aging; Cognitive Behavioral Therapy; Cognitive Dysfunction; Cognitive Remediation; Dementia; Drosophila melanogaster; Female; Humans; Hypnotics and Sedatives; Intellectual Disability; Neural Pathways; Pregnancy; Prenatal Exposure Delayed Effects; Risk Factors; Selective Serotonin Reuptake Inhibitors; Serotonin and Noradrenaline Reuptake Inhibitors; Sleep; Vortioxetine