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临床试验/NCT01601210
NCT01601210已完成早期 1 期

Placebo-Controlled Dose-Ranging Trial of Creatine Augmentation for Adolescent Females With Treatment-Resistant Major Depressive Disorder: a Magnetic Resonance Spectroscopy Study

Perry Renshaw1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2012年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
已完成
发起方
入组人数
32
试验地点
1
主要终点
Brain PCr concentrations

研究概览

简要总结

The purpose of this study is to see if creatine, which is a naturally occurring chemical in the body, is effective for treating Major Depressive Disorder (MDD) in female teenagers.

The primary hypothesis is that compared to placebo, 2g, 4g, and 10g of creatine monohydrate for eight weeks will be associated with a significant increase in brain phosphocreatine (PCr) concentrations.

详细描述

The purpose of this study is to see if creatine, which is a naturally occurring chemical in the body, is effective for treating Major Depressive Disorder (MDD) in female teenagers. Creatine may have effects of interest in the brain. The reason for the MRI component of this study is to learn about new ways to see inside the brain. The investigators will use magnetic fields and radio waves to look at the brain and chemicals in the brain. The investigators hope that this technique will have medial use in the future.

The primary hypothesis is that compared to placebo, 2g, 4g, and 10g of creatine monohydrate for eight weeks will be associated with a significant increase in brain phosphocreatine (PCr) concentrations. A secondary hypothesis is that decreased depressive symptoms measured with the Children Depression Rating Scale-Revised (CDRS-R) and Montgomery Asberg Depression Rating Scale (MADRS) will be reciprocally correlated with increased β-NTP concentrations.

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
13 Years 至 21 Years(Child, Adult)
性别
Female
接受健康志愿者
否

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Placebo

Placebo Comparator

干预措施: Creatine monohydrate or placebo (Drug)

10 grams of creatine

Active Comparator

干预措施: Creatine monohydrate or placebo (Drug)

4 grams of creatine

Active Comparator

干预措施: Creatine monohydrate or placebo (Drug)

2 grams of creatine

Active Comparator

干预措施: Creatine monohydrate or placebo (Drug)

结局指标

主要结局

Brain PCr concentrations

时间窗: 8 weeks

The primary hypothesis is that compared to placebo, 2g, 4g, and 10g of creatine monohydrate for eight weeks will be associated with a significant increase in brain phosphocreatine (PCr) concentrations.

次要结局

未报告次要终点

研究者

发起方
Perry Renshaw
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Perry Renshaw

MD, PhD, MBA

University of Utah

研究点 (1)

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