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

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 d...

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Autores principales: Santos García, Diego, Alonso Losada, Maria Gema, Cimas Hernando, Icíar, Cabo López, Iria, Yáñez Baña, Rosa, Alonso Redondo, Ruben, Paz González, Jose Manuel, Cores Bartolomé, Carlos, Feal Painceiras, Maria José, Íñiguez Alvarado, Maria Cristina, Labandeira, Carmen, García Díaz, Iago
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9688230/
https://www.ncbi.nlm.nih.gov/pubmed/36358393
http://dx.doi.org/10.3390/brainsci12111466
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author Santos García, Diego
Alonso Losada, Maria Gema
Cimas Hernando, Icíar
Cabo López, Iria
Yáñez Baña, Rosa
Alonso Redondo, Ruben
Paz González, Jose Manuel
Cores Bartolomé, Carlos
Feal Painceiras, Maria José
Íñiguez Alvarado, Maria Cristina
Labandeira, Carmen
García Díaz, Iago
author_facet Santos García, Diego
Alonso Losada, Maria Gema
Cimas Hernando, Icíar
Cabo López, Iria
Yáñez Baña, Rosa
Alonso Redondo, Ruben
Paz González, Jose Manuel
Cores Bartolomé, Carlos
Feal Painceiras, Maria José
Íñiguez Alvarado, Maria Cristina
Labandeira, Carmen
García Díaz, Iago
author_sort Santos García, Diego
collection PubMed
description 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.
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spelling pubmed-96882302022-11-25 Vortioxetine Improves Depressive Symptoms and Cognition in Parkinson’s Disease Patients with Major Depression: An Open-Label Prospective Study Santos García, Diego Alonso Losada, Maria Gema Cimas Hernando, Icíar Cabo López, Iria Yáñez Baña, Rosa Alonso Redondo, Ruben Paz González, Jose Manuel Cores Bartolomé, Carlos Feal Painceiras, Maria José Íñiguez Alvarado, Maria Cristina Labandeira, Carmen García Díaz, Iago Brain Sci Article 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. MDPI 2022-10-29 /pmc/articles/PMC9688230/ /pubmed/36358393 http://dx.doi.org/10.3390/brainsci12111466 Text en © 2022 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Santos García, Diego
Alonso Losada, Maria Gema
Cimas Hernando, Icíar
Cabo López, Iria
Yáñez Baña, Rosa
Alonso Redondo, Ruben
Paz González, Jose Manuel
Cores Bartolomé, Carlos
Feal Painceiras, Maria José
Íñiguez Alvarado, Maria Cristina
Labandeira, Carmen
García Díaz, Iago
Vortioxetine Improves Depressive Symptoms and Cognition in Parkinson’s Disease Patients with Major Depression: An Open-Label Prospective Study
title Vortioxetine Improves Depressive Symptoms and Cognition in Parkinson’s Disease Patients with Major Depression: An Open-Label Prospective Study
title_full Vortioxetine Improves Depressive Symptoms and Cognition in Parkinson’s Disease Patients with Major Depression: An Open-Label Prospective Study
title_fullStr Vortioxetine Improves Depressive Symptoms and Cognition in Parkinson’s Disease Patients with Major Depression: An Open-Label Prospective Study
title_full_unstemmed Vortioxetine Improves Depressive Symptoms and Cognition in Parkinson’s Disease Patients with Major Depression: An Open-Label Prospective Study
title_short Vortioxetine Improves Depressive Symptoms and Cognition in Parkinson’s Disease Patients with Major Depression: An Open-Label Prospective Study
title_sort vortioxetine improves depressive symptoms and cognition in parkinson’s disease patients with major depression: an open-label prospective study
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9688230/
https://www.ncbi.nlm.nih.gov/pubmed/36358393
http://dx.doi.org/10.3390/brainsci12111466
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