Comparative Efficacy of Antidepressants With L-methylfolate, B12, and Magnesium in Depressive Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Patient Health Questionnaire (PHQ-9)
研究概览
简要总结
The aim of this clinical trial is to compare the effect of antidepressants in combination with different dietary supplements in patients with depression. Our main objective is to compare the efficacy of antidepressants in combination with either L-methyl folate, Vit B12, or magnesium) in patients with depressive disorders. The levels of depressive symptoms as measured by the Patient Health Questionnaire (PHQ-9) at base level and during follow-up.
详细描述
This is an open-label study assessing the comparative efficacy of antidepressants in combination therapy of either L-methylfolate, mecobalamin, or magnesium in patients with Depressive Disorder. The plan is to enroll 84 patients with depression based on Patient Health Questionnaire (PHQ-9) score of 9 and above, which is a valid and reliable Structured Clinical Interview. The investigators will collect data from the enrolled patient populations. The participants will be able to receive their results, on request, upon completion of the study. The investigators hypothesize that depressive symptoms can be improved by the addition of above mentioned nutritional supplementations with antidepressant medication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Depressive Disorder having PHQ-9 Score 9 and above
- •Age 12 and above
- •Patients having low/marginal and low normal levels for arms 2 and 3 of respective supplements
- •Patients having low/normal serum magnesium for arm 4
排除标准
- •Patients having psychiatric diagnosis other than Depressive Disorder according to the International Classification of Diseases 11th Revision (ICD-11)
- •History of kidney disease, myasthenia gravis
- •Mentally handicapped or terminally ill patients
- •Age less than 12 years
- •Patients already taking multiple nutritional supplements
- •Patients on polypharmacy with potential interactions with antidepressants and supplements in this study.
结局指标
主要结局
Patient Health Questionnaire (PHQ-9)
时间窗: Baseline and 4 weeks
The change in the total PHQ-9 score between baseline and 4-weeks follow-up is the primary outcome measure. This measure is a patient-rated inventory of depressive symptoms. All items are scored on scales ranging from 0-3 and the sum of the scores provides the total score for the measure. On this scale, higher scores indicate poorer outcomes. Scores 9-19 and 20-27 are considered moderate and severe depression respectively.
次要结局
- Depressive symptoms remission(Baseline, 2 weeks, 4 weeks)
- Patient Health Questionnaire (PHQ-9)(Baseline, 2-weeks and 4-weeks)
- Side-effects(Baseline, 2-weeks, and 4-weeks follow up)