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

• Status: Completed
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bangor University
• Collaborators: Cardiff University; NHS Health Technology Assessment Programme; North East Wales NHS Trust; North West Wales NHS Trust; Swansea NHS Trust; Swansea University; University of Liverpool
• Treatments: Folic Acid; Vitamin B Complex

Criteria

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