Folate Augmentation of Treatment - Evaluation for Depression: a Randomised Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 730
- 试验地点
- 3
- 主要终点
- Self rated symptoms of depression using the Beck Depression Inventory
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Folic Acid
干预措施: Folic Acid (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Self rated symptoms of depression using the Beck Depression Inventory
时间窗: Repeated measures up to 6 months after initiation of folic acid/placebo
次要结局
- Clinician rated depression using the Montgomery-Asberg Depression Rating Scale(Repeated measures up to 6 months after initiation of folic acid/placebo)
- Clinician rated symptom severity using the Clinical Global Impression scale(Repeated measures up to 6 months after initiation of folic acid/placebo)
- Health status using the SF12(Repeated measures up to 6 months after initiation of folic acid/placebo)
- Adverse events(Repeated measures up to 6 months after initiation of folic acid/placebo)
- Cost Utility using the EuroQol, resource use questionnaire and medication history(Repeated measures up to 6 months after initiation of folic acid/placebo)
- Folate status(Baseline, 3 months and 6 months)
- Homocysteine Status(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(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(12 weeks and 6 months)