Vortioxetine Improves Depressive Symptoms and Cognition in Parkinson’s Disease Patients with Major Depression: An Open-Label Prospective Study

Abstract

Depression is frequent in Parkinson’s disease (PD) patients, but the evidence for many antidepressant agents to treat it in PD is insufficient. The aim of the present prospective open-label single-arm study (VOPARK, an open-label study of the effectiveness and safety of VOrtioxetine in PARKinson´s disease patients with depression) was to analyze the effectiveness of vortioxetine on depressive symptoms in PD patients with major depression. The primary efficacy outcome was the change from baseline (VB) at the end of the observational period (12 weeks ± 14 days; V12w) in the 17-item Hamilton Depression Rating Scale (HAM-D17) total score. At VB, all patients had a HAM-D17 total score ≥16. A total of 30 patients (age 66.23 ± 10.27; 73.3% males) were included between February 2021 (first patient, 12/FEB/21) and March 2022 (last patient, 14/MAR/22). At 12 weeks, 27 patients completed the follow-up (90%). The total HAM-D17 total score was reduced by 52.7% (from 21.5 ± 4.75 at VB to 10.44 ± 7.54 at V12w; Cohen’s effect size = −2.5; p < 0.0001) and the response and remission rates were 50% and 43.3%, respectively. Apathy (Apathy Scale; p < 0.0001), cognition (PD-Cognitive Rating Scale; p = 0.007), fatigue (Fatigue Severity Scale; p = 0.014), and quality of life (PDQ-39 (p = 0.001) and EUROHIS-QOL8 (p < 0.0001)) improved at 3 weeks as well. A total of 11 adverse events in 10 patients (33.3%) were reported, one of which was severe (vomiting related to vortioxetine with full recovery after drug withdrawal). Vortioxetine was safe and well tolerated and improved depressive symptoms and other non-motor symptoms in PD patients.

Treatment of Apathy in Parkinson’s Disease and Implications for Underlying Pathophysiology

“…A recent single-arm open-label study, the VOPARK study, evaluated vortioxetine as a therapy for depressive symptoms suffered by PD patients who concurrently met diagnostic criteria for major depressive disorder. The investigators found that as well as improving mood, there was a significant effect on apathy as measured using the apathy scale [26]. While we could not find any further studies that evaluate the effect of vortioxetine on apathy, one trial found a significant short-term effect on anhedonia.…”

“…The most extensively researched and commonly prescribed pharmacological treatments for apathy are dopaminergic agents (e.g., rotigotine) and cholinesterase inhibitors (e.g., rivastigmine) [1,25]. However, the list of trialled therapies continues to grow, and recently published studies have examined vortioxetine [26] and the experimental compound pirepemat [27]. Non-pharmacological therapies that have shown specific benefits for apathy in PD include exercise therapy and mindfulness.…”

Individualized strategies for depression: narrative review of clinical profiles responsive to vortioxetine

“…Vortioxetine has been shown to be well-tolerated and efficacious in patients with MDD and comorbid physical conditions, such as cardiovascular disease, diabetes mellitus, Parkinson’s disease [ 53 ] and, to a lesser extent, chronic obstructive pulmonary disorders (COPD) [ 54 ]. Notably, vortioxetine’s effectiveness and tolerability extend to older populations, who often deal with multiple comorbidities and polypharmacy [ 55 ].…”

The Role of Vortioxetine in the Treatment of Depressive Symptoms in General Hospital Psychiatry: A Case-Series and PRISMA-Compliant Systematic Review of the Literature

“…These articles report encouraging results in the treatment of negative, cognitive and affective symptoms of schizophrenia [108][109][110], along with preliminary effectiveness in bipolar depression [111], burning mouth syndrome [112], postmenopausal depression [113], and panic disorder [114]. A further group of studies (n = 5) demonstrated that vortioxetine treatment is associated with affective and cognitive symptoms amelioration in patients with neurological conditions, including neurocognitive decline [115][116][117], Parkinson's disease [118], and post-stroke depression [119]. Interestingly, three studies report data suggesting that vortioxetine could be an effective strategy to reduce SSRI-induced emotional blunting [120][121][122].…”