Moderate to severe depression Mental and Behavioural Disorders Depression
Conditions
Interventions
Folic acid 5 mg versus placebo supplementation to antidepressant therapy.
Sponsors
University of Wales Bangor (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Symptom severity as estimated by the self-rated Beck Depression Inventory (BDI) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United Kingdom, Wales
Outcome results
None listed