Major Depressive Disorder Clinical Trial
Official title:
Placebo-Controlled Dose-Ranging Trial of Creatine Augmentation for Adolescent Females With Treatment-Resistant Major Depressive Disorder: a Magnetic Resonance Spectroscopy Study
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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