Folate augmentation of treatment - evaluation for depression
| ISRCTN | ISRCTN37558856 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN37558856 |
| EudraCT/CTIS number | 2006-004647-37 |
| ClinicalTrials.gov number | NCT00514410 |
| Secondary identifying numbers | HTA 04/35/08 |
- Submission date
- 29/08/2006
- Registration date
- 30/08/2006
- Last edited
- 13/09/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
One in five people experience depression during their lives. Only half of those treated with drugs will get better; many others experience symptoms for a long time. The most common type of treatment for depression is a drug known as an antidepressant. These work by improving the way in which certain chemical messengers work in the brain. The vitamin called folate, found in foods such as green vegetables, helps to produce the chemicals used by these messengers in the brain. So low levels of folate, caused by poor diet or similar factors, may worsen or even cause depression, and may stop antidepressants from working as well as they should. This means that taking folate tablets could help treat depression. However, very few studies have been done to test this. This study will test whether giving a tablet of folate every day to people with depression will help their antidepressants work better.
Who can participate?
Patients aged 18 or over with moderate to severe depression
What does the study involve?
Participants are randomly allocated to take either a folate tablet or a dummy tablet for 3 months in addition to their antidepressant. To test whether folate tablets help antidepressants to work better, we assess whether those taking the tablets achieve better health. To do this we measure peoples' symptoms of depression at different times during the study. We also check their blood to see how much folate they have at different times during the study. We shall use some of the blood samples to see whether any genes affect the way folate helps treat depression.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
University of Wales Bangor (UK)
When is the study starting and how long is it expected to run for?
October 2006 to June 2011
Who is funding the study?
Health Technology Assessment Programme (UK)
Who is the main contact?
Prof. Ian Russell
ian.russell@bangor.ac.uk
Contact information
Scientific
IMSCaR
Brigantia Building
Penrallt Road
Bangor
LL57 2AS
United Kingdom
| Phone | +44 (0)1248 383617 |
|---|---|
| ian.russell@bangor.ac.uk |
Study information
| Study design | Multi-centred double-blind placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Folate Augmentation of Treatment - Evaluation for Depression: a randomised controlled trial |
| Study acronym | FolATED |
| Study hypothesis | 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. More details can be found at: http://www.nets.nihr.ac.uk/projects/hta/043508 Protocol can be found at: http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0003/51078/PRO-04-35-08.pdf |
| Ethics approval(s) | MREC for Wales, 06/11/2006, CTA ref: 21996/0001/001-0001 |
| Condition | Moderate to severe depression |
| Intervention | Folic acid 5 mg versus placebo supplementation to antidepressant therapy. |
| Intervention type | Supplement |
| Primary outcome measure | Symptom severity as estimated by the self-rated Beck Depression Inventory (BDI) |
| Secondary outcome measures | 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 |
| Overall study start date | 01/10/2006 |
| Overall study end date | 30/06/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 730 |
| Participant inclusion criteria | 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. |
| Participant exclusion criteria | 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 |
| Recruitment start date | 01/10/2006 |
| Recruitment end date | 30/06/2011 |
Locations
Countries of recruitment
- United Kingdom
- Wales
Study participating centre
LL57 2AS
United Kingdom
Sponsor information
University/education
Brigantia Building
Penrallt Road
Bangor
LL57 2AS
Wales
United Kingdom
| Phone | +44 (0)1248 383617 |
|---|---|
| ian.russell@bangor.ac.uk | |
| Website | http://www.bangor.ac.uk/index.php.en?width=1024&height=768 |
"ROR" |
https://ror.org/006jb1a24 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Health Technology Assessment Programme, HTA
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 15/11/2007 | Yes | No | |
| Results article | results | 01/07/2014 | Yes | No | |
| Results article | Methylmalonic acid levels | 11/09/2021 | 13/09/2021 | Yes | No |
Editorial Notes
13/09/2021: Publication reference added.
07/06/2016: Plain English summary added.
26/08/2009: the overall trial end date of this trial was changed from 30/06/2009 to 30/06/2011.
