Folate Augmentation of Treatment - Evaluation for Depression: a Randomised Controlled Trial

NCT ID: NCT00514410

Last Updated: 2011-10-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 730 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2011-05-31

Brief Summary

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.

Detailed Description

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.

Conditions

Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Folic Acid

Group Type: EXPERIMENTAL

Folic Acid

Intervention Type: DRUG

Folic acid 5 mg once a day for three months as a supplement to their antidepressant treatment

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching placebo taken once a day for three months

Interventions

Folic Acid

Folic acid 5 mg once a day for three months as a supplement to their antidepressant treatment

Intervention Type: DRUG

Placebo

Matching placebo taken once a day for three months

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Only patients aged 18 or over
• ICD-10 diagnosis of moderate to severe depression
• Able to give informed consent (not delirious, actively psychotic or with severe communication or learning disability)
• Able to complete the research assessments

Exclusion Criteria

• are folate deficient
• are B12 deficient
• have knowingly taken supplements containing folic acid within 2 months
• suffer from psychosis
• are already participating in another research project
• are pregnant or planning to become pregnant
• are taking anticonvulsants
• have a serious, advanced or terminal illness with a life expectancy of less than 1 year
• have recently started treatment for a medical condition which has not yet been stabilised
• are taking lithium
• have had a diagnosis or treatment for any malignant disease or any related condition such as intestinal polyposis

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NHS Health Technology Assessment Programme

OTHER

Sponsor Role: collaborator

Swansea University

OTHER

Sponsor Role: collaborator

Cardiff University

OTHER

Sponsor Role: collaborator

University of Liverpool

OTHER

Sponsor Role: collaborator

North West Wales NHS Trust

OTHER

Sponsor Role: collaborator

North East Wales NHS Trust

OTHER

Sponsor Role: collaborator

Swansea NHS Trust

OTHER_GOV

Sponsor Role: collaborator

Bangor University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ian T Russell, PhD, HonFRCGP, FRCP Edin, FFPH

Role: PRINCIPAL_INVESTIGATOR

Swansea University

Keith Lloyd, MBBS, MSc, MRC Psych, MSc, MD

Role: PRINCIPAL_INVESTIGATOR

Swansea University

Locations

North West Wales Trust

Bangor, Gwynedd, United Kingdom

Swansea University

Swansea, Swansea, United Kingdom

Cardiff University

Wrexham, Wrexham, United Kingdom

Countries

United Kingdom

References

Roberts SH, Bedson E, Hughes D, Lloyd K, Menkes DB, Moat S, Pirmohamed M, Slegg G, Thome J, Tranter R, Whitaker R, Wilkinson C, Russell I. Folate augmentation of treatment - evaluation for depression (FolATED): protocol of a randomised controlled trial. BMC Psychiatry. 2007 Nov 15;7:65. doi: 10.1186/1471-244X-7-65.

Reference Type: BACKGROUND

PMID: 18005429 (View on PubMed)

Other Identifiers

ISRCTN37558856

Identifier Type: -

Identifier Source: secondary_id

G0373

Identifier Type: -

Identifier Source: org_study_id