Folate Augmentation of Treatment – Evaluation for Depression (FolATED): protocol of a randomised controlled trial

<p>Abstract</p> <p>Background</p> <p>Clinical depression is common, debilitating and treatable; one in four people experience it during their lives. The majority of sufferers are treated in primary care and only half respond well to active treatment. Evidence suggests that folate may be a useful adjunct to antidepressant treatment: 1) patients with depression often have a functional folate deficiency; 2) the severity of such deficiency, indicated by elevated homocysteine, correlates with depression severity, 3) low folate is associated with poor antidepressant response, and 4) folate is required for the synthesis of neurotransmitters implicated in the pathogenesis and treatment of depression.</p> <p>Methods/Design</p> <p>The primary objective of this trial is to estimate the effect of folate augmentation in new or continuing treatment of depressive disorder in primary and secondary care. Secondary objectives are to evaluate the cost-effectiveness of folate augmentation of antidepressant treatment, investigate how the response to antidepressant treatment depends on genetic polymorphisms relevant to folate metabolism and antidepressant response, and explore whether baseline folate status can predict response to antidepressant treatment.</p> <p>Seven hundred and thirty patients will be recruited from North East Wales, North West Wales and Swansea. Patients with moderate to severe depression will be referred to the trial by their GP or Psychiatrist. If patients consent they will be assessed for eligibility and baseline measures will be undertaken.</p> <p>Blood samples will be taken to exclude patients with folate and B12 deficiency. Some of the blood taken will be used to measure homocysteine levels and for genetic analysis (with additional consent). Eligible participants will be randomised to receive 5 mg of folic acid or placebo. Patients with B12 deficiency or folate deficiency will be given appropriate treatment and will be monitored in the 'comprehensive cohort study'. Assessments will be at screening, randomisation and 3 subsequent follow-ups.</p> <p>Discussion</p> <p>If folic acid is shown to improve the efficacy of antidepressants, then it will provide a safe, simple and cheap way of improving the treatment of depression in primary and secondary care.</p> <p>Trial registration</p> <p>Current controlled trials ISRCTN37558856</p

Nanotechnology and Risk Governance in the European Union: the Constitution of Safety in Highly Promoted and Contested Innovation Areas

[EN]The European Union (EU) is strategically committed to the development of nanotechnology and its industrial exploitation. However, nanotechnology also has the potential to disrupt human health and the environment. The EU claims to be committed to the safe and responsible development of nanotechnology. In this sense, the EU has become the first governing body in the world to develop nanospecific regulations, largely due to legislative action taken by the European Parliament, which has compensated for the European Commission’s reluctance to develop special regulations for nanomaterials. Nevertheless, divergences aside, political bodies in the EU assume that nanotechnology development is controllable and take for granted that both the massive industrial use of nanomaterials and a high level of environmental and health protection are compatible. However, experiences such as the European controversy over agri-food biotechnology, which somewhat delegitimized the regulatory authority of the EU over technological safety and acceptability, arguably show that controllability assumptions are contestable on the grounds of alternative socio-economic and cultural preferences and values. Recently developed inclusive governance models on safety and innovation, such as"Responsible Research and Innovation" (RRI), widelyclaim that a diversity of considerations and issues areintegrated into R&D processes. Even so, the possibility of more radically alternative constitutions of sociotechnical safety seems to be seriously limited by the current ideology of innovation and economic imperatives of the global, knowledge-based, capitalist economy.This work is based mainly upon research supported by the Basque Government’s Department of Education, Universities and Research under a Postdoctoral Fellowship for the Improvement of Research Personnel in a Foreign Country (grant BFI08.183). It has also been supported by the Basque Government’s Department of Education, Language Policy and Culture (grant IT644-13), the Spanish Ministry of Economy and Competitiveness and the European Regional Development Fund (grant FFI2015-69792-R), and the University of the Basque Country UPV/EHU (grant EHUA15/13). The author also wishes to thank Heather A. Okvat for her assistance in revising the initial, original version of the article, and to two anonymous reviewers for their constructive and thorough comments on the present version. Any shortcomings in the work remain the responsibility of the author

Rehabilitation of Mediterranean animal forests using gorgonians from fisheries by‐catch

The assessment of effective and affordable restoration interventions is pivotal to developing new tools to mitigate habitat loss and enhance natural recovery. Gorgonians create important three-dimensional habitats in the Mediterranean Sea providing several ecosystem services associated with coralligenous reefs. Transplantations of the octocorals Eunicella cavolini, E. singularis, and Paramuricea clavata were carried out at the site impacted by the wreck of the Costa Concordia in 2012. A total of 135 by-caught gorgonians, caught in the gears of local artisanal fishermen or found lying on the seabed by SCUBA divers, were transplanted on impacted coralligenous reefs between 20 and 35 m depth and monitored for 2.5 years. A high survival rate (82.1%) was recorded, with main losses attributable to the detachment of the organisms from the substrate rather than death of the colonies. Eunicella cavolini transplanted colonies and natural colonies used as controls were monitored and showed similar, and seasonally influenced, growth and healing rates. Epibiosis and necrosis events were reported in both transplanted and natural colonies during summer, highlighting the sensitivity of the species to thermal stress. The present study emphasizes the importance of a management framework as a stepping-stone to achieve effective restoration outcomes, including the removal of pressures that caused changes in natural communities and the participation of local stakeholders. The effectiveness of the methods and procedures proposed in this work allowed the restoration activities to continue at a larger scale during summer and autumn 2020