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Introduction: Depression is a highly prevalent condition in the elderly, with a vast impact on quality of life, life expectancy, and medical outcomes. Selective serotonin reuptake inhibitors (SSRIs) are the most commonly prescribed agents in this condition and, although generally safe, tolerability issues cannot be overlooked. Vortioxetine is an antidepressant with a novel mechanism of action. Based on studies to date, it may have a promising tolerability profile in the elderly, as it does not adversely affect psychomotor or cognitive performance and does not alter cardiovascular and endocrine parameters. The present study aims to assess the tolerability profile of vortioxetine in comparison with the SSRIs considered as a single group in elderly participants with depression. The rate of participants withdrawing from treatment due to adverse events after 6 months of follow up will be the primary outcome.
Methods And Analysis: This is a pragmatic, multicentre, open-label, parallel-group, superiority, randomized trial funded by the Italian Medicines Agency (AIFA - Agenzia Italiana del Farmaco). Thirteen Italian Community Psychiatric Services will consecutively enrol elderly participants suffering from an episode of major depression over a period of 12 months. Participants will be assessed at baseline and after 1, 3 and 6 months of follow up. At each time point, the following validated rating scales will be administered: Montgomery-Åsberg Depression Rating Scale (MADRS), Antidepressant Side-Effect Checklist (ASEC), EuroQual 5 Dimensions (EQ-5D), Short Blessed Test (SBT), and Charlson Age-Comorbidity Index (CACI). Outcome assessors and the statistician will be masked to treatment allocation. A total of 358 participants (179 in each group) will be enrolled.
Ethics And Dissemination: This study will fully adhere to the ICH E6 Guideline for Good Clinical Practice. Participants' data will be managed and safeguarded according to the European Data Protection Regulation 2016/679. An external Ethical Advisory Board will help guarantee high ethical standards.
Trial Registration: Clinicaltrials.gov: NCT03779789 , Registered on 19 December 2018. Submitted on 19 December. EudraCT number: 2018-001444-66.
Trial Status: Protocol version 1.5; 09/06/2018. Recruitment started In February 2019 and it is ongoing. It is expected to end approximately on 30 September 2021.
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http://dx.doi.org/10.1186/s13063-020-04460-6 | DOI Listing |
ACS Chem Biol
December 2024
UNC Eshelman School of Pharmacy, Center for Integrative Chemical Biology and Drug Discovery, Chemical Biology and Medicinal Chemistry, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina 27599, United States.
Tudor domains are histone readers that can recognize various methylation marks on lysine and arginine. This recognition event plays a key role in the recruitment of other epigenetic effectors and the control of gene accessibility. The Tudor-containing protein family contains 42 members, many of which are involved in the development and progression of various diseases, especially cancer.
View Article and Find Full Text PDFExpert Opin Drug Saf
December 2024
Department of Gastrointestinal Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA.
Introduction: Biliary tract cancer (BTC) originates from the biliary epithelium of the small ducts within the liver (intrahepatic cholangiocarcinoma, IHCC), the main ducts of the hilum (extrahepatic cholangiocarcinoma, EHCC), or in the gallbladder (gallbladder cancer, GC). Due to presentation with nonspecific symptoms as well as absence of screening, most patients present with advanced disease and unfavorable prognosis.
Areas Covered: The ABC-02 trial established the current first-line chemotherapy with gemcitabine/platinum for advanced BTC in 2010.
AbstractSenescence is ubiquitous yet highly variable among species, populations, and individuals, for reasons that are poorly understood. It is not clear how environmental conditions affect senescence, especially in the wild. We explored the influence of environment on the degree of laying date age-specific variation and reproductive success senescence in wild blue tits.
View Article and Find Full Text PDFAbstractClimate change will affect both the mean and the variability in environmental conditions and may have major negative impacts on population densities in the future. For annual plants that already live in an extreme environment like the Sonoran Desert, keeping a fraction of their seeds dormant underground (for possibly years at a time) is critical to survive. Here, we consider how this form of bet hedging (i.
View Article and Find Full Text PDFAbstractThe ability to secure food for offspring and withstand the cost of reproduction favors high-quality mothers that overproduce the larger sex, typically sons, only if they will receive adequate food, as this should enhance these sons' fitness returns. However, high-quality daughters ensure that grandoffspring receive quality parental care and may possess greater reproductive value than their brothers, favoring daughters also from high-quality mothers. Using a mixed cross-fostering approach, we investigated effects of early rearing conditions, covariance between breeders and their genetic parents in parental quality, and primary offspring sex ratios in Carolina wrens.
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