Folate augmentation of treatment - Evaluation for depression (FolATED): Protocol of a randomised controlled trial

BMC Psychiatry

Volumn 7, Issue , 2007, Pages

  Roberts, Seren Haf ^a   Bedson, Emma ^a   Hughes, Dyfrig ^a   Lloyd, Keith ^b   Moat, Stuart ^c   Pirmohamed, Munir ^d   Slegg, Gary ^a   Tranter, Richard ^e   Whitaker, Rhiannon ^a   Wilkinson, Clare ^f   Russell, Ian ^a  

^a BANGOR UNIVERSITY   (United Kingdom)

^b SWANSEA UNIVERSITY   (United Kingdom)

^c UNIVERSITY HOSPITAL OF WALES   (United Kingdom)

^d UNIVERSITY OF LIVERPOOL   (United Kingdom)

^e YSBYTY GWYNEDD   (United Kingdom)

^f CARDIFF UNIVERSITY   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIDEPRESSANT AGENT; FOLIC ACID; HOMOCYSTEINE; FLUOXETINE;

ADJUVANT THERAPY; ARTICLE; BECK DEPRESSION INVENTORY; BLOOD SAMPLING; CLINICAL GLOBAL IMPRESSION SCALE; CLINICAL RESEARCH; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; COST BENEFIT ANALYSIS; COST EFFECTIVENESS ANALYSIS; CYANOCOBALAMIN DEFICIENCY; DEPRESSION; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG RESPONSE; DRUG SAFETY; DRUG TOLERABILITY; FOLATE METABOLISM; FOLIC ACID DEFICIENCY; GENETIC ANALYSIS; GENETIC POLYMORPHISM; HEALTH STATUS; HUMAN; MAJOR CLINICAL STUDY; MENTAL HEALTH; MONTGOMERY ASBERG DEPRESSION RATING SCALE; MULTICENTER STUDY; NEUROTRANSMITTER RELEASE; PATIENT MONITORING; PHARMACOGENETICS; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; UNITED KINGDOM; ADULT; BLOOD; COHORT ANALYSIS; DRUG COMBINATION; ECONOMICS; FEMALE; FOLLOW UP; GENERAL PRACTICE; MALE; PSYCHIATRY;

ADULT; ANTIDEPRESSIVE AGENTS, SECOND-GENERATION; COHORT STUDIES; COST-BENEFIT ANALYSIS; DEPRESSIVE DISORDER; DOUBLE-BLIND METHOD; DRUG THERAPY, COMBINATION; FAMILY PRACTICE; FEMALE; FLUOXETINE; FOLIC ACID; FOLLOW-UP STUDIES; HOMOCYSTEINE; HUMANS; MALE; PSYCHIATRY;

EID: 39049092670     PISSN: None     EISSN: 1471244X     Source Type: Journal    
DOI: 10.1186/1471-244X-7-65     Document Type: Article

References (49)

1. Murray CJL Lopez AD Global mortality, disability and the contribution of risk factors. Global Burden of Disease Study. Lancet 1997, 349:1436 10.1016/S0140-6736(96)07495-8 9164317
2. Musselman DL Evans DL Nemeroff CB The Relationship of Depression to Cardiovascular Disease: Epidemiology, Biology, and Treatment Arch Gen Psychiatry 1998, 55:580-592 10.1001/archpsyc.55.7.580 9672048
3. Royal College of Psychiatrists Council The psychological care of medical patients: A practical guide. Report of a joint working party of the Royal College of Physicians and the Royal College of Psychiatrists London, Royal College of Physicians of London and Royal College of Psychiatrists 2003
4. National Institute for Clinical Excellence Depression: Management of depression in primary and secondary care London, National Institute for Clinical Excellence 2004
5. Agency for Health Care Policy and Research Treatment for Depression - newer pharmocotherapies. Summary, Evidence Report. 1999
6. Parker G Mitchell P Wilhelm K Menkes DB Snowdon J Schweitzer I Grounds D Skerrit P Roy K Hadzi-Pavlovic D Are the newer antidepressant drugs as effective as established physical treatments? Results from an Australasian clinical panel review. Australian and New Zealand Journal of Psychiatry 1999, 33:874-881 10.1046/j.1440-1614.1999.00648.x
7. Botez MI Young SN Bachevalier J Gauthier S Folate deficiency and decreased brain 5-hydroxytryptamine synthesis in man and rat Nature 1979, 278:182-183 10.1038/278182a0 763364
8. Carney MWP Serum folate values in 423 psychiatric patients British Medical Journal 1967, 512 1749137 6065984
9. Fava M Borus JS Alpert JE Nierenberg AA Rosenbaum JF Bottiglieri T Folate, vitamin B12, and homocysteine in major depressive disorder American Journal of Psychiatry 1997, 154:426-428 9054796
10. Tiemeier H van Tuijl HR Hofman A Meijer J Kiliaan AJ Breteler MM Vitamin B12, folate, and homocysteine in depression: The Rotterdam Study American Journal of Psychiatry 2002, 159:2099-2101 10.1176/ appi.ajp.159.12.2099 12450964
11. Sachdev PS Parslow RA Lux O Salonikas C Wen W Naidoo D Christensen H Jorm AF Relationship of homocysteine, folic acid and vitamin B12 with depression in a middle-aged community sample Psychological Medicine 2005, 35:529-538 10.1017/S0033291704003721 15856723
12. Bjelland I Tell GS Vollset SE Refsum H Ueland PM Folate, vitamin B12, homocysteine, and the MTHFR 677C→T polymorphism in anxiety and depression: The Hordaland Homocysteine Study Arch Gen Psychiatry 2003, 60:618-626 10.1001/archpsyc.60.6.618 12796225
13. Lucock M Folic acid: Nutritional biochemistry, molecular biology, and role in disease processes Molecular Genetics & Metabolism 2000, 71:121-138 10.1006/mgme.2000.3027
14. Taylor MJ Carney SM Goodwin GM Geddes JR Folate for depressive disorders: Systematic review and meta-analysis of randomized controlled trials Journal of Psychopharmacology 2004, 18:251-256 10.1177/ 0269881104042630 15260915
15. Taylor MJ Carney S Geddes J G. G Folate for depressive disorders. The Cochrane Database of Systematic Reviews 2003, 12804463
16. Coppen A Bailey J Enhancement of the antidepressant action of fluoxetine by folic acid: A randomised, placebo controlled trial Journal of Affective Disorders 2000, 60:121-130 10.1016/S0165-0327(00)00153-1 10967371
17. Godfrey PS Toone BK Carney MW Flynn TG Bottiglieri T Laundy M Chanarin I Reynolds EH Enhancement of recovery from psychiatric illness by methylfolate Lancet 1990, 336:392-395 10.1016/0140-6736(90)91942-4 1974941
18. Alpert M Silva RR Pouget ER Prediction of treatment response in geriatric depression from baseline folate level: Interaction with an SSRI or a tricyclic antidepressant J Clin Psychopharmacol 2003, 23:309-313 10.1097/00004714-200306000-00012 12826993
19. Harden CL Goldstein MA Mood disorders in patients with epilepsy: epidemiology and management CNS Drugs 2002, 16:291-302 10.2165/ 00023210-200216050-00002 11994019
20. Moat SJ Doshi SN Lang D McDowell IFW Lewis MJ Goodfellow J Treatment of coronary heart disease with folic acid: Is there a future? American Journal of Physiology Heart & Circulatory Physiology 2004, 287:H1-H7 10.1152/ajpheart.00952.2003
21. Moat SJ McDowell IFW Homocysteine and endothelial function in human studies Seminars in Vascular Medicine 2005, 5:172-182 10.1055/ s-2005-872402 16047269
22. Moat SJ Madhavan A Taylor SY Payne N Allen RH Stabler SP Goodfellow J McDowell IFW Lewis MJ Lang D High- but not low-dose folic acid improves endothelial function in coronary artery disease European Journal of Clinical Investigation 2006, 36:850-859 10.1111/j.1365-2362.2006.01739.x
23. Campbell NR How safe are folic acid supplements? Archives of Internal Medicine 1996, 156:1638-1644 10.1001/archinte.156.15.1638 8694661
24. Lingjaerde O Ahlfors UG Bech P Dencker SJ Elgen K The UKU side effect rating scale. A new comprehensive rating scale for psychotropic drugs and a cross-sectional study of side effects in neuroleptic-treated patients. Acta Psychiatrica Scandinavica, Supplementum 1987, 334:1-100 10.1111/j.1600-0447.1987.tb10566.x
25. Morisky DE Green LW Levine DM Concurrent and predictive validity of a self-reported measure of medication adherence. Medical Care 1986, 24:67-74 10.1097/00005650-198601000-00007 3945130
26. George CF Peveler RC Heiliger S Thompson C Compliance with tricyclic antidepressants: The value of four different methods of assessment British Journal of Clinical Pharmacology 2000, 50:166-171 10.1046/ j.1365-2125.2000.00244.x 10930969 2014396
27. British Medical Association and Royal Pharmaceutical Society of Great Britain British National Formulary Vol. Volume 50. London, British Medical Association 2007 September 2005
28. Parker G Roy K Menkes DB Snowdon J Boyce P Grounds D Hughson B Stringer C How long does is take antidepressant therapies to work? Australian and New Zealand Journal of Psychiatry 2000, 34:65-70 10.1046/ j.1440-1614.2000.00684.x
29. Nierenberg AA Farabaugh AH Alpert JE Gordon J Worthington JJ Rosenbaum JF Fava M Timing of Onset of Antidepressant Response with Fluoxetine Treatment American Journal of Psychiatry 2000, 157:1423-1428 10.1176/ appi.ajp.157.9.1423 10964858
30. Gershon S Antidepressants: Can we determine how quickly they work? Psychopharmacology Bulletin 1995, 31:21-22
31. Posternak MA Zimmerman M Dual Reuptake Inhibitors Incur Lower Rates of Tachyphylaxis Than Selective Seretonin Reuptake Inhibitors: A retrospective Study Journal of Clinical Psychiatry 2005, 66:705-707 15960562
32. Dervieux T Kremer J Lein DO Capps R Barham R Meyer G Smith K Caldwell J Furst DE Contribution of common polymorphism in reduced folate carrier and gamma-glutamylhydrolase to methotrexate polyglutamate levels in patients with rheumatoid arthritis. Pharmacogenetics 2004, 14:733-739 10.1097/00008571-200411000-00004 15564880
33. Owen A Goldring C Morgan P Chadwick D Park BK Pirmohamed M Relationship between the C3435T and G2677T(A) polymorphisms in the ABCB1 gene and P-glycoprotein expression in human liver. British Journal of Clinical Pharmacology 2005, 59:365-370 10.1111/j.1365-2125.2005.02229.x 15752383 1884787
34. Seaman SR Muller-Myhsok B Rapid simulation of P values for product methods and multiple-testing adjustments in association studies. American Journal of Human Genetics 2005, 76:399-408 1196392 15645388 10.1086/428140
35. Moat SJ Doshi SN Lang D McDowell IFW Lewis MJ J. G Treatment of coronary heart disease with folic acid: Is there a future? Am J Physiol Heart Circ Physiol 2004, 287:H1-H7 10.1152/ajpheart.00952.2003 15210447
36. Office of Dietary Supplements Dietary Supplement Fact Sheet: Folate http://www.ods.od.nih.gov/factsheet/folate.asp
37. The European Parliament and the Council of the European Union Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 Official Journal of European Union 2001 Article 2 L121/36 L121/37
38. Coppen A Bolander-Gouaille C Treatment of depression: Time to consider folic acid and vitamin B12 Journal of Psychopharmacology 2005, 19:59-65 10.1177/0269881105048899 15671130
39. Papakostas GI Petersen T Mischoulon D et al Serum folate, vitamin B12, and homocystine in major depressive disorder. J Clin Psychiatry 2004, 65:1090-1098 15323594
40. Department of Health Reference Costs 2004 Collections: Costing and Activities Guidance and Requirements London, Department of Health, 2005
41. Curtis L Netten A Unit Costs of Health and Social Care 2004, Personal Social Services Research Unit, University of Kent 2004
42. Peveler R Kendrick T Buxton M Longworth L Baldwin D M M Chatwin J Goddard J Thornett A Smith H Campbell M Thompson C A randomised controlled trial to compare the cost-effectiveness of tricyclic antidepressants, selective serotonin reuptake inhibitors and lofepramine Health Technology Assessment, 2005 9
43. Majumdar SK Shaw GK Offerman EL Thomson AD Relationship between depression and haematological status in chronic alcoholics Neuropharmacology 1981, 20:1351-1352 7322307
44. Medical Research Council MRC Guidelines For Good Clinical Practice In Clinical Trials London, Medical Research Council 1998:1-49
45. Medical Research Council A framework for development and evaluation of RCTs for complex interventions to improve health. London, Medical Research Council 2000:1-18
46. Medical Research Council Good Research Practice London, Medical Research Council 2000:1-18
47. Department of Health Research Governance Framework for Health and Social Care London, Department of Health 2001:1-50
48. Wales Office for Research and Development in Health and Social Care Research Governance Framework for Health and Social Care in Wales Cardiff, Welsh Assembly Government 2001:1-43
49. Great Britain Human Tissue Act 2004 Elizabeth II. Chapter 30, London, The Stationery Office. 2004