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

October 11, 2011 updated by: Bangor University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

730

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Swansea, United Kingdom, sa2 8pp
        • Swansea University
      • Wrexham, United Kingdom, LL13 7YP
        • Cardiff University
    • Gwynedd
      • Bangor, Gwynedd, United Kingdom, LL57 2PW
        • North West Wales Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Matching placebo taken once a day for three months
Experimental: Folic Acid
Drug: Folic Acid
Folic acid 5 mg once a day for three months as a supplement to their antidepressant treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Self rated symptoms of depression using the Beck Depression Inventory
Time Frame: Repeated measures up to 6 months after initiation of folic acid/placebo
Repeated measures up to 6 months after initiation of folic acid/placebo

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinician rated depression using the Montgomery-Asberg Depression Rating Scale
Time Frame: Repeated measures up to 6 months after initiation of folic acid/placebo
Repeated measures up to 6 months after initiation of folic acid/placebo
Clinician rated symptom severity using the Clinical Global Impression scale
Time Frame: Repeated measures up to 6 months after initiation of folic acid/placebo
Repeated measures up to 6 months after initiation of folic acid/placebo
Health status using the SF12
Time Frame: Repeated measures up to 6 months after initiation of folic acid/placebo
Repeated measures up to 6 months after initiation of folic acid/placebo
Adverse events
Time Frame: Repeated measures up to 6 months after initiation of folic acid/placebo
Repeated measures up to 6 months after initiation of folic acid/placebo
Cost Utility using the EuroQol, resource use questionnaire and medication history
Time Frame: Repeated measures up to 6 months after initiation of folic acid/placebo
Repeated measures up to 6 months after initiation of folic acid/placebo
Folate status
Time Frame: Baseline, 3 months and 6 months
Baseline, 3 months and 6 months
Homocysteine Status
Time Frame: Baseline, 3 months and 6 months
Baseline, 3 months and 6 months
The interaction between any of the genetic polymorphisms in the folate pathway that predicts the severity of depression, response to antidepressants, and the response to folate supplementation
Time Frame: Baseline only
Baseline only
Compliance - using the number of tablets remaining at each follow up, dispensing records for folic acid or placebo, dates of repeat prescriptions, Morisky questionnaire, red cell folate and homocysteine levels
Time Frame: 12 weeks and 6 months
12 weeks and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bangor University

Collaborators

Cardiff University
Swansea University
University of Liverpool
NHS Health Technology Assessment Programme
North West Wales NHS Trust
North East Wales NHS Trust
Swansea NHS Trust

Investigators

  • Principal Investigator: Ian T Russell, PhD, HonFRCGP, FRCP Edin, FFPH, Swansea University
  • Principal Investigator: Keith Lloyd, MBBS, MSc, MRC Psych, MSc, MD, Swansea University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

August 9, 2007

First Submitted That Met QC Criteria

August 9, 2007

First Posted (Estimate)

August 10, 2007

Study Record Updates

Last Update Posted (Estimate)

October 12, 2011

Last Update Submitted That Met QC Criteria

October 11, 2011

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • G0373
  • ISRCTN37558856

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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