Folate Augmentation of Treatment – Evaluation of Depression: a randomised controlled trial - FolATED

Phase 1

• Conditions: Individuals with moderate to severe depression according to ICD-10 criteria.; MedDRA version: 8.1Level: LLTClassification code 10012378Term: Depression

• Registration Number: EUCTR2006-004647-37-GB
• Lead Sponsor: Bangor University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09-29
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Only patients aged 18 or over with an ICD-10 diagnosis of moderate to severe depression [confirmed by the trial psychiatrists during the screening interview using the 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients will be excluded from the study if they
(a)are folate deficient:they cannot be randomised because they need to be treated with folic acid but can be included in the comprehensive cohort
(b)are B12 deficient: they cannot be randomised because they need to be treated with B12 injections but can be included in the comprehensive cohort
(c)have knowingly taken supplements containing folic acid within 2 months because this will mask any effects of folic acid given during the study
(d)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.
(e)suffer from bipolar disorder
(f)are already participating in another research project
(g)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
(h)are taking anticonvulsants as in very rare circumstances folic acid can react with certain anticonvulsants
(i)serious, advanced or terminal illness with a life expectancy of less than 1 year
(j)have recently started treatment for a medical condition which has not yet been stabilised
(k)have had a diagnosis or treatment for any malignant disease or any related condition such as intestinal polyposis

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified