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

Roberts, Seren Haf; Bedson, Emma; Hughes, Dyfrig; Lloyd, Keith; Moat, Stuart; Pirmohamed, Munir; Slegg, Gary; Tranter, Richard; Whitaker, Rhiannon; Wilkinson, Clare and Russell, Ian (2007) Folate Augmentation of Treatment – Evaluation for Depression (FolATED): protocol of a randomised controlled trial. BMC Psychiatry, 7 . Article Number: 65. ISSN 1471-244X

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Abstract

Background: 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. Methods/Design: 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. 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.

Item Type:Article
Additional Information:19 pages (page numbers not for citation purposes). Published: 15 November 2007.
Uncontrolled Keywords:FOLIC-ACID; SERUM FOLATE; ANTIDEPRESSANT; VITAMIN-B-12; DISEASE; HOMOCYSTEINE; FLUOXETINE; POLYMORPHISMS; EPIDEMIOLOGY; ENHANCEMENT
Subjects:R Medicine > R Medicine (General)
R Medicine > RC Internal medicine > RC0321 Neuroscience. Biological psychiatry. Neuropsychiatry
Departments, Research Centres and Related Units:Academic Faculties, Institutes and Research Centres > Faculty of Medicine > School of Biomedical Sciences
DOI:10.1186/1471-244X-7-65
Publisher's Statement:© 2007 Roberts et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Related URLs:
Refereed:Yes
Status:Published
ID Code:676
Deposited On:25 Jun 2008 09:40
Last Modified:20 May 2011 09:04

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