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ISRCTN
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ISRCTN37558856
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ClinicalTrials.gov identifier
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NCT00514410
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Public title
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Folate Augmentation of Treatment - Evaluation for Depression: a randomised controlled trial
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Scientific title
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Acronym
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FolATED
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Serial number at source
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HTA 04/35/08
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Study hypothesis
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The primary objective of this trial is to estimate the effect of folate augmentation in new or continuing treatment of depressive disorder in primary, intermediate 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.
Please note that, as of 26/08/2009, the anticipated end date of this trial has been updated from 30/06/2009 to 30/06/2011.
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Lay summary
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Ethics approval
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Full ethics approval received from the MREC for Wales on the 6th November 2006 (CTA ref: 21996/0001/001-0001; EudraCT number: 2006-004647037).
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Study design
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Multi-centred double blind placebo controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Moderate to severe depression
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Participants - inclusion criteria
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Only patients aged 18 or over with an International Classification of Diseases (ICD-10) diagnosis of moderate to severe depression (confirmed by the trial psychiatrists during the screening interview using Beck Depression Inventory [BDI]) will be included. Only patients able to give informed consent (not delirious, actively psychotic or with severe communication or learning disability) and able to complete the research assessments will be included.
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Participants - exclusion criteria
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1. Patients that are folate deficient (provisionally set at less than 2.5 ng/l): they cannot be randomised because they need to be treated with folic acid but can be included in the comprehensive cohort
2. Are B12 deficient (provisionally set at less than 150 pg/mL): they cannot be randomised because they need to be treated with B12 injections but can be included in the comprehensive cohort
3. Have knowingly taken supplements containing folic acid within two months because this will mask any effects of folic acid given during the study
4. Substance misuse because people who use drug and alcohol typically have low folate levels
5. Suffer from psychosis because additional treatment for psychosis may mask any benefit of folic acid with antidepressants. Plus people suffering from psychosis are less able to give informed consent and will require referral through to secondary services
6. Are already participating in another research project
7. Are pregnant or planning to become pregnant as it is important for pregnant women to take folic acid so they cannot be randomised to placebo
8. Are taking anticonvulsants as in very rare circumstances folic acid can react with certain anticonvulsants
9. Serious, advanced or terminal illness with a life expectancy of less than one year
10. Have recently started treatment for a medical condition which has not yet been stabilised
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Anticipated start date
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01/10/2006
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Anticipated end date
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30/06/2011
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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730
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Interventions
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Folic Acid 5 mg versus placebo supplementation to antidepressent therapy.
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Primary outcome measure(s)
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Symptom severity as estimated by the self-rated Beck Depression Inventory (BDI).
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Secondary outcome measure(s)
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1. Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS)
2. Clinical Global Impression (CGI) of change
3. SF-12 short form health survey
4. Adverse events and side effects as measured by the UKU side effect scale
5. EuroQoL (EQ-5D)
6. Health Resource Use questionnaire
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Sources of funding
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NIHR Health Technology Assessment Programme - HTA (UK)
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Trial website
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Publications
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Contact name
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Prof
Ian
Russell
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Address
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IMSCaR
Brigantia Building
Penrallt Road
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City/town
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Bangor
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Zip/Postcode
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LL57 2AS
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Country
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United Kingdom
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Tel
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+44 (0) 1248 383617
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Fax
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+44 (0) 1248 383002
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Email
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ian.russell@bangor.ac.uk
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Sponsor
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University of Wales Bangor (UK)
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Address
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Brigantia Building
Penrallt Road
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City/town
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Bangor
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Zip/Postcode
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LL57 2AS
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Country
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United Kingdom
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Tel
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+44 (0) 1248 383617
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Fax
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+44 (0) 1248 383002
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Email
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ian.russell@bangor.ac.uk
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Sponsor website:
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http://www.bangor.ac.uk/index.php.en?width=1024&height=768
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Date applied
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29/08/2006
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Last edited
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26/08/2009
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Date ISRCTN assigned
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30/08/2006
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