Creatine for Treatment of Depression Associated With Type 2 Diabetes
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Change from Baseline in Hamilton Depression Rating Scale
研究概览
简要总结
The investigators hypothesize that the administration of a widely available, naturally occurring dietary supplement, creatine monohydrate, will reduce the severity of depression in individuals with type 2 diabetes. The purpose of this study is to determine whether 12 weeks of creatine supplementation is an effective treatment for depression in individuals with type 2 diabetes.
详细描述
Depression is a debilitating illness associated with diminished quality of life and significant personal and societal costs. Depression is twice as common in those with type 2 diabetes compared to the general population. Antidepressants are commonly prescribed as treatment for depression; however, they may not be the optimal treatment for people with type 2 diabetes. Creatine has been shown to decrease symptoms of depression in many types of individuals when used over the course of 8 weeks or more. The purpose of this study is to investigate whether creatine can decrease symptoms of depression in individuals with type 2 diabetes when taken daily for 12 weeks. This study also investigates how creatine impacts brain chemistry as creatine decreases depressive symptoms.
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
- 20 Years 至 64 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Current diagnosis of Major Depressive Disorder identified by the SCID-5-RV
- •Current HAM-D score of > 16
- •Current type 2 diabetes (as confirmed by clinical history and baseline glycosylated hemoglobin percentage (HgA1c) > 6.
- •Diabetes type II present for at least one year
排除标准
- •Diagnosis of bipolar disorder, schizophrenia, or schizoaffective disorder, identified by the SCID-5-RV
- •History of or current diagnosis of acute kidney injury (AKI), chronic kidney disease (CKD) or end-stage renal disease (ESRD)
- •Electrolyte disturbance (hypokalemia, hyperkalemia, hyponatremia, or hypernatremia) on screening basic metabolic panel
- •History of cardiac disease or QTc >500ms on screening EKG
- •History of diabetic ketoacidosis or hyperosmolar hyperglycemic state
- •History of seizure disorder
- •Current serious suicide risk identified by the Columbia Severity Suicide Rating Scale
- •Positive pregnancy test
- •Breastfeeding
- •Contraindication to an MRI scan
- •Current incarceration
研究组 & 干预措施
Open Label Treatment with Creatine
5 grams daily of oral creatine monohydrate powde
干预措施: Creatine Monohydrate (Drug)
结局指标
主要结局
Change from Baseline in Hamilton Depression Rating Scale
时间窗: 12 weeks
The purpose of this study is to determine whether 12 weeks of dietary creatine augmentation with oral 5 g creatine daily reduces hypoxia-related depressive symptoms measured by the 17-item Hamilton Depression Rating Scale (HAM-D) in women with SSRI or SNRI resistant depression.
次要结局
未报告次要终点
研究者
Perry Renshaw
MD, PhD, MBA
University of Utah