Efficacy and Safety of Augmentation of Creatine for the Patients With Major Depressive Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 5
- 主要终点
- Hamilton depression rating scale
研究概览
简要总结
Given 1) the established safety with short-term or long-term supplementation of Cr, 2) its potential usefulness in improving brain energy metabolism, 3) the reported abnormality in brain energy metabolism in MDD subjects, and 4) plausible association between depression and inflammatory mediators, we hypothesize that oral Cr augmentation will help reduce symptoms in MDD patients as well as normalize a deficit in brain energy metabolism and that improvement of MDD and brain energy metabolism will be correlated with inflammatory mediators changes.
In this study, we plan to conduct an randomized, double-blind, placebo-controlled augmentation study with creatine in addition to escitalopram. We will assess the efficacy and safety of the Cr augmentation and evaluate changes relevant to brain energy metabolism and inflammatory mediators.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •19-65 year-old male or female
- •Major depressive disorder diagnosed by SCID-IV
- •Hamilton depression rating scale score >= 16 at screening
- •Written informed consent
排除标准
- •Suicidal idea that needs hospitalization
- •Any other axis I psychiatric disorder
- •Neurologic disease (eg., epilepsy, infarct, multiple sclerosis, brain tumor)
- •IQ below 80
- •Inflammatory disease including autoimmune disease
- •Taking anti-inflammatory medication
- •Serious physical disease
- •Substance abuse or dependence history in recent 6 months
- •Pregnant or having plan to be pregnant
结局指标
主要结局
Hamilton depression rating scale
时间窗: baseline, 1st, 2nd, 4th, 8th week
次要结局
- Clinical global impression scale(baseline, 1st, 2nd, 4th, 8th week)
- Side effects assessment: the interview and examination by the investigators(baseline, 1st, 2nd, 4th, 8th week)
- Serum inflammatory mediators (eg., IL-1, -2, PGE2, interferon gamma) level(baseline, 8th week)
- Serum creatinine level(baseline, 2nd, 8th week)
- Brain MRI(baseline, 8th week)
- Montgomery-Asberg depression scale(baseline, 1st, 2nd, 4th, 8th week)
研究者
In Kyoon Lyoo
Professor
Ewha Womans University