Open-Label Creatine Monohydrate Supplementation in Depressed Female Methamphetamine Users
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Depression Rating Scores
研究概览
简要总结
Study Purposes and Objectives:
The objectives should be stated in such a way that the reader can determine the appropriateness of the study design. If appropriate, state the specific hypotheses being tested and/or study aims. Use lay language.
Methamphetamine use is of great concern in the state of Utah because it's the primary drug of threat in the state, and is the primary drug of choice among females between the ages of 18 and 24. The primary hypothesis of the study is that eight weeks of oral creatine supplementation will result in improvements in depression rating scores in female MA users. Secondary hypotheses include the following: 1) creatine supplementation will result in a decrease in the number of positive MA screens; 2) NAA and Cr concentrations will increase after eight weeks of oral creatine supplementation; and 3) PCr/β-NTP levels in the frontal lobe using 31P MRS will increase after eight weeks of creatine monohydrate oral supplementation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 55 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Must be female
- •Must be between the ages of 13 and 55 years
- •Methamphetamine must be primary drug of choice
- •Must have used methamphetamine within the last 6 months
- •For participants > 18 years of age, must have a Hamilton Depression Rating Scale (HDRS or HAM-D) score of > 17
- •For participants < 18 years of age, must have a Children Depression Rating Scale (CDRS) score of > 40
- •Must be able to give informed consent
排除标准
- •Significant current or past medical conditions, such as cardiovascular, renal or endocrine disorders
- •DSM-IV diagnosis of bipolar disorder, schizophrenia, or schizoaffective disorder
- •Known pregnancy or positive urine HCG test
- •Current serious homicidal or suicidal risk
- •Young Mania Rating Scale (YMRS) score > 7
- •Inability to comply with the protocol
- •Contraindication to an MR scan
- •Positive HIV test
- •Known sensitivity to creatine monohydrate
- •Inclusion criteria for healthy comparison group:
- •Must be female
- •Must be between the ages of 13 and 55 years
- •Must be able to give informed consent
- •Exclusion criteria for healthy comparison group:
- •Significant current medical illness
- •DSM-IV disorder identified by the SCID (to include bipolar I, bipolar II, bipolar NOS, major depressive disorder, dysthymia disorder, depressive disorder NOS, primary psychotic symptoms, substance use disorders, and anxiety disorders)
- •Known pregnancy or positive urine HCG test
- •Contraindication to an MR scan
- •Inability to comply with the protocol
- •Positive urine drug screen (unless it is positive for a low dose prescription opiate that is taken as prescribed)
研究组 & 干预措施
Creatine monohydrate
干预措施: Creatine monohydrate (Drug)
结局指标
主要结局
Depression Rating Scores
时间窗: 8-week
Hamilton Depression Rating Scale scores is used to assess the level of depression. The Hamilton Depression Rating Scale ranges from 0 to 50. A score of 0-7 is considered to be normal. A score of 8-13 indicates mild depression. A score of 14-18 indicates moderate depression. Scores higher than 19 indicate severe depression.
次要结局
- Phosphocreatine Levels Measured by Magnetic Resonance Spectroscopy(8 weeks)
研究者
Perry Renshaw
Professor of Psychiatry
University of Utah