A randomized controlled trial to assess the effect of riboflavin supplementation with antidepressant treatment in persons with major depressive disorder.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- To assess the effect of 3 months riboflavin supplementation with antidepressants (SSRI/SNRI) treatment in patients of Indian origin with major depressive disorder (MDD) on depression severity as assessed by HDRS score.
研究概览
简要总结
Thisstudy aims to find out the correlation of treatment response with geneexpression and DNA methylation signatures in persons with major depressivedisorder and also to investigate the potential of riboflavin supplementationwith antidepressants treatment to alter these, which will lead to improvedefficacy, tolerability and ultimately better quality of life. This will be adouble-blind placebo-controlled trial and will be conducted upon patients withMDD. Patients of MDD diagnosed clinically who have not started /within 15 daysof antidepressant treatment will be screened in psychiatry OPD, AIIMS, NewDelhi and those meeting the inclusion criteria will be enrolled for the study.They will be randomly assigned into two groups (treatment or placebo group)where the treatment group will receive supplementation of riboflavin andplacebo group will receive matching placebo as per the dosing schedule ofriboflavin along with the ongoing antidepressants regimen for 3 months.Patients of both groups will be followed up at 3 months of supplementation andall parameters assessed in the baseline will be re-evaluated. Any adverseevents during the intervention will be monitored and reported to correspondingauthorities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Subject of age 18-55 years of either gender.
- •Patients of MDD diagnosed clinically who have not started /within 15 days of antidepressant treatment Patients who are prescribed any of the antidepressants (SSRI/SNRI) as monotherapy by the psychiatrist Patients who can read and understand.
- •Patients who are willing to participate and give consent.
排除标准
- •Pregnant or seeking pregnancy, lactating women Patients suffering from any chronic disease like cardiac diseases, respiratory diseases, liver disease, malignancy, peptic ulcer etc, which are known to affect inflammatory or neurodegenerative markers.
- •Associated neurological diseases other than depression Progressive brain diseases like alzheimers disease, parkinsons disease, multiple sclerosis.
结局指标
主要结局
To assess the effect of 3 months riboflavin supplementation with antidepressants (SSRI/SNRI) treatment in patients of Indian origin with major depressive disorder (MDD) on depression severity as assessed by HDRS score.
时间窗: 3 Years
次要结局
- To compare the expression of the identified proteins/genetic biomarkers levels (BDNF, SLC6A4, HTR1A, HTR1B, IL11) in Indian subjects with MDD (before and after riboflavin intervention) vs. healthy control.(3 Years)
- To assess the effect of riboflavin supplementation with antidepressants (SSRI/SNRI) treatment on the oxidative stress (total antioxidant capacity) and safety parameters (renal function test, liver function test and complete blood count).(3 Years)
- To assess the effect of riboflavin supplementation with antidepressants (SSRI/SNRI) treatment on the quality of life as assessed by HRQoL and social cognition score assessed by SOCRATIS.(3 Years)
- To correlate change in treatment response (HDRS score) with the change in identified proteins/genetic biomarkers levels, and oxidative stress.(3 Years)