NCT02134808

Creatine Augmentation for Adolescent Females With Treatment-Resistant Major Depressive Disorder

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: Perry Renshaw · Academic / Other
• Sex: Female
• Age: 12 Years – 21 Years
• Healthy volunteers: Accepted

Summary

The primary hypothesis is that compared to placebo, 10g of daily creatine monohydrate for eight weeks will be associated with significant increases in frontal lobe phosphocreatine and beta-nucleoside triphosphate (β-NTP) concentrations. A secondary hypothesis is that decreased depressive symptoms measured with the Children's Depression Rating Scale-Revised (CDRS-R) and Montgomery-Asberg Depression Rating Scale (MADRS) will be reciprocally correlated with increased β-NTP concentrations.

Detailed description

The current protocol seeks to expand upon the investigators previous work by opening recruitment on a pilot study of creatine 10g daily vs. placebo as a treatment for female adolescents with SSRI-resistant MDD. The purpose of the pilot study is twofold: A) to evaluate several aspects of the feasibility of creatine supplementation as a treatment for this population; and B) to estimate the effect size of adjunctive creatine, to inform the design and implementation of a potential future efficacy trial.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	Creatine	Creatine is a nutritional supplement.
DRUG	Placebo	The placebo is an inactive ingredient similar in appearance, weight and density to the active treatment.

Timeline

• Start date: 2014-11-21
• Primary completion: 2017-06-27
• Completion: 2017-06-27
• First posted: 2014-05-09
• Last updated: 2024-07-03
• Results posted: 2024-07-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study