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

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Roberts, Seren Haf, Bedson, Emma, Hughes, Dyfrig ORCID: 0000-0001-8247-7459, Lloyd, Keith, Moat, Stuart, Pirmohamed, Munir ORCID: 0000-0002-7534-7266, Slegg, Gary, Tranter, Richard, Whitaker, Rhiannon, Wilkinson, Clare et al (show 1 more authors) and Russell, Ian (2007) Folate Augmentation of Treatment-Evaluation for Depression (FolATED): protocol of a randomised controlled trial. BMC PSYCHIATRY, 7 (1). 65-.

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Abstract

<h4>Background</h4>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.<h4>Methods/design</h4>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. 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.<h4>Discussion</h4>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.<h4>Trial registration</h4>Current controlled trials ISRCTN37558856.

Item Type:	Article
Additional Information:	19 pages (page numbers not for citation purposes). Published: 15 November 2007.
Uncontrolled Keywords:	Humans, Fluoxetine, Folic Acid, Homocysteine, Antidepressive Agents, Second-Generation, Drug Therapy, Combination, Cohort Studies, Follow-Up Studies, Double-Blind Method, Depressive Disorder, Psychiatry, Family Practice, Adult, Cost-Benefit Analysis, Female, Male
Subjects:	?? R1 ?? ?? RC0321 ??
Divisions:	Faculty of Health and Life Sciences > Institute of Systems, Molecular and Integrative Biology
Depositing User:	Symplectic Admin
Date Deposited:	25 Jun 2008 08:40
Last Modified:	16 Dec 2022 02:03
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:	Author Publisher
URI:	https://livrepository.liverpool.ac.uk/id/eprint/676