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Sponsors and Collaborators: |
Bangor University NHS Health Technology Assessment Programme Swansea University Cardiff University University of Liverpool North West Wales NHS Trust North East Wales NHS Trust Swansea NHS Trust |
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Information provided by: | Bangor University |
ClinicalTrials.gov Identifier: | NCT00514410 |
To determine whether giving folic acid to people with depression will help their antidepressants work better. If folate does help antidepressants to work better, then it will provide a safe, simple and cheap way of improving the treatment of depression.
Condition | Intervention | Phase |
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Depression |
Drug: Folic Acid Drug: Placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Folate Augmentation of Treatment - Evaluation for Depression: a Randomised Controlled Trial |
Estimated Enrollment: | 730 |
Study Start Date: | July 2007 |
Estimated Study Completion Date: | July 2009 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Folic Acid: Experimental |
Drug: Folic Acid
Folic acid 5 mg once a day for three months as a supplement to their antidepressant treatment
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Placebo: Placebo Comparator |
Drug: Placebo
Matching placebo taken once a day for three months
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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.
The primary objective of this multi-centred placebo-controlled randomised 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.
Comparisons: Eligible patients with moderate to severe depression will be randomised to receive 5mg of folic acid or placebo as an adjunct to their antidepressant treatment.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Emma Bedson, BSc, PhD | +44 (0)1978 727406 | folated@bangor.ac.uk |
Contact: Seren H Roberts, DipN (M), RN (M), BSc, PhD | +44 (0)1978 727406 | folated@bangor.ac.uk |
United Kingdom | |
Swansea University | Recruiting |
Swansea, United Kingdom, SA2 8PP | |
Principal Investigator: Keith R Lloyd, MBBS, MSc, MRC Psych, MSc, MD | |
Cardiff University | Recruiting |
Wrexham, United Kingdom, LL13 7YP | |
Principal Investigator: Seren H Roberts, DipN (M), RN (M), BSc, PhD | |
United Kingdom, Gwynedd | |
North West Wales Trust | Recruiting |
Bangor, Gwynedd, United Kingdom, LL57 2PW | |
Principal Investigator: Richard Tranter, BA, BSc, MBChB, MRCPsych |
Principal Investigator: | Ian T Russell, PhD, HonFRCGP, FRCP Edin, FFPH | Bangor University |
Principal Investigator: | Keith Lloyd, MBBS, MSc, MRC Psych, MSc, MD | Swansea University |
Responsible Party: | Bangor University ( Prof Ian Russell ) |
Study ID Numbers: | G0373, ISRCTN37558856 |
Study First Received: | August 9, 2007 |
Last Updated: | August 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00514410 |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Depression Folate Folic acid Antidepressants |
Folic Acid Depression Mental Disorders |
Mood Disorders Depressive Disorder Behavioral Symptoms |
Vitamin B Complex Hematinics Therapeutic Uses Growth Substances Vitamins |
Hematologic Agents Physiological Effects of Drugs Micronutrients Pharmacologic Actions |