Role of L-Methylfolate in Treatment of Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Change in HAM-D score
研究概览
简要总结
There is a neurophysiologic rationale for folate augmentation of antidepressant therapy involving both biochemical and genetic factors. The studies evaluating the effectiveness of L-methylfolate are few and have been mostly conducted on treatment resistant patients. Hence, the number of available trials remains small and heterogeneity between such studies high. The overall review of literature shows scarcity of studies on the role of folate, especially the bioavailable L-methylfolate, at the time of initiation of antidepressant for the treatment of depression. This present study is aimed to compare the efficacy and tolerability of L-methylfolate in the treatment of depression and evaluate the predictors of response to L-methylfolate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with primary diagnosis of moderate to severe depression according to ICD-10 DCR criteria.
- •These patients should be treatment naïve or if receiving treatment should have regular compliance to it for at least 6 weeks and not be responding to the current treatment as defined by response of <50% of global improvement as reported by the patient and the caregivers.
- •Patients having HAM-D score of ≥17, at time of intake which indicates at least moderate degree of depression.
- •Patient and his/her relative willing to give informed consent.
排除标准
- •Breastfeeding, and pregnant females 2) Having a current serious suicide risk, or psychotic symptoms 3) Unstable medical illness requiring concomitant use of other medication including those medications which are known to have depressogenic effect ( corticosteroids, anti-epileptics, beta-blockers, quinolone class of antibiotics, interferons, anti-neoplastic drugs).
- •Having an active substance use disorder within the past 6 months (in terms of fulfilling criteria for substance-harmful use or substance dependence) except nicotine and caffeine use.
- •Having past history of mania/hypomania (including antidepressant-induced), psychotic symptoms, or seizure disorder.
- •Taking vitamins or dietary supplements containing folate or vitamin B
- •Having comorbid diagnosis of intellectual disability, dementia, Alzheimer’s disease, or Parkinson’s disease.
结局指标
主要结局
Change in HAM-D score
时间窗: 0,2,4,6,8 weeks
次要结局
- Change in quality of life and functioning(0,4,8 weeks)