Dose-Ranging Trial of Creatine Augmentation for Adolescent Females With Treatment-Resistant Major Depressive Disorder
- Conditions
- Major Depressive Disorder
- Interventions
- Registration Number
- NCT01601210
- Lead Sponsor
- Perry Renshaw
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 32
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 10 grams of creatine Creatine monohydrate or placebo - Placebo Creatine monohydrate or placebo - 2 grams of creatine Creatine monohydrate or placebo - 4 grams of creatine Creatine monohydrate or placebo -
- Primary Outcome Measures
Name Time Method Brain PCr concentrations 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Utah
🇺🇸Salt Lake City, Utah, United States
University of Utah🇺🇸Salt Lake City, Utah, United States