DepressionPhase 4FolATEDNCT00514410
Folate Augmentation of Treatment - Evaluation for Depression: a Randomised Controlled Trial
A Phase 4 study testing Folic Acid in people with Depression, run by Bangor University at 3 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Folic Acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 730 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- Jul 2007to May 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
North West Wales Trust
Bangor, Gwynedd, LL57 2PW
Swansea University
Swansea, Swansea, SA2 8PP
Cardiff University
Wrexham, Wrexham, LL13 7YP
About this study
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.
Read the 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
- Being tested
- Folic Acid, Placebo
- Keywords
- Depression, Folate, Folic acid, Antidepressants
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Folic AcidDrug
Folic acid 5 mg once a day for three months as a supplement to their antidepressant treatment
PlaceboDrug
Matching placebo taken once a day for three months
| Study group | Role | What they receive |
|---|---|---|
| Folic Acid | Experimental | Not described Receives: Drug: Folic Acid |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self rated symptoms of depression using the Beck Depression Inventory
Measured: Repeated measures up to 6 months after initiation of folic acid/placebo
Secondary outcomes (9)
Clinician rated depression using the Montgomery-Asberg Depression Rating Scale
Measured: Repeated measures up to 6 months after initiation of folic acid/placebo
Clinician rated symptom severity using the Clinical Global Impression scale
Measured: Repeated measures up to 6 months after initiation of folic acid/placebo
Health status using the SF12
Measured: Repeated measures up to 6 months after initiation of folic acid/placebo
Adverse events
Measured: Repeated measures up to 6 months after initiation of folic acid/placebo
Cost Utility using the EuroQol, resource use questionnaire and medication history
Measured: Repeated measures up to 6 months after initiation of folic acid/placebo
Folate status
Measured: Baseline, 3 months and 6 months
Homocysteine Status
Measured: 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
Measured: 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
Measured: 12 weeks and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2007 (estimated)
- Study startJul 2007
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 730 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bangor University
- Sponsor type
- University, hospital or other
- Collaborators
- 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
- Responsible party
- Sponsor
- Investigators
- Ian T Russell, PhD, HonFRCGP, FRCP Edin, FFPH, Principal investigator, Swansea UniversityKeith Lloyd, MBBS, MSc, MRC Psych, MSc, MD, Principal investigator, Swansea University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00514410
- Sponsor's protocol ID
- G0373
- Other IDs
- ISRCTN37558856
- Acronym
- FolATED
- Status last verified
- Feb 2009
- First submitted
- 9 Aug 2007
- Last updated
- 12 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 18005429
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Folate Augmentation of Treatment - Evaluation for Depression: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT00514410
- Acronym / sponsor ID
- FolATED / G0373
- Conditions
- Depression
- Keywords
- Depression, Folate, Folic acid, Antidepressants
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 730 participants (estimated)
- Lead sponsor
- Bangor UniversityUniversity, hospital or other
- Collaborators
- 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
- Study start
- Jul 2007
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 10 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Folic Acid | Experimental | Drug: Folic Acid |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Folic AcidFolic acid 5 mg once a day for three months as a supplement to their antidepressant treatment | Drug | Folic Acid |
| PlaceboMatching placebo taken once a day for three months | Drug | Placebo |
Primary outcome
Self rated symptoms of depression using the Beck Depression Inventory
Time frame: Repeated measures up to 6 months after initiation of folic acid/placebo
9 secondary outcomes
Clinician rated depression using the Montgomery-Asberg Depression Rating Scale
Time frame: 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
Health status using the SF12
Time frame: 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
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
Folate status
Time frame: Baseline, 3 months and 6 months
Homocysteine Status
Time frame: 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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2011.
- Background: PubMed 18005429Roberts 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ian T Russell, PhD, HonFRCGP, FRCP Edin, FFPH principal investigator
Swansea University
Keith Lloyd, MBBS, MSc, MRC Psych, MSc, MD principal investigator
Swansea University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Folic Acid in people with Depression, run by Bangor University at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self rated symptoms of depression using the Beck Depression Inventory (time frame: Repeated measures up to 6 months after initiation of folic acid/placebo). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00514410, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2011.