Creatine Augmentation for Adolescent Females With Treatment-Resistant Major Depressive Disorder
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|ClinicalTrials.gov Identifier: NCT02134808|
Recruitment Status : Active, not recruiting
First Posted : May 9, 2014
Last Update Posted : December 7, 2017
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder||Drug: Creatine Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||71 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Placebo-Controlled Trial of Creatine Augmentation for Adolescent Females With Treatment-Resistant Major Depressive Disorder: a Magnetic Resonance Spectroscopy Study|
|Actual Study Start Date :||March 15, 2017|
|Estimated Primary Completion Date :||February 2021|
|Estimated Study Completion Date :||February 2021|
Active Comparator: Creatine
Subjects randomized to this study arm will receive 10 grams of creatine daily for 8 weeks.
Creatine is a nutritional supplement.
Other Name: Creatine Monohydrate
Placebo Comparator: Placebo
Subjects randomized to this study arm will receive 10 grams of placebo daily for 8 weeks.
The placebo is an inactive ingredient similar in appearance, weight and density to the active treatment.
Other Name: Placebo Control
- Brain phosphocreatine (PCr) concentrations [ Time Frame: 8 weeks ]PCr will be measured through phosphorus magnetic resonance spectroscopy (31P-MRS). This will be performed in a 3 Tesla magnetic resonance imaging (MRI) scanner.
- Children's Depression Rating Scale-Revised (CDRS-R); Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 8 weeks ]The CDRS-R and MADRS will be administered to understand the severity of depressive symptoms, and how these symptoms change throughout the course of the study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02134808
|United States, Utah|
|University of Utah School of Medicine|
|Salt Lake City, Utah, United States, 84108|
|Study Director:||Douglas Kondo, MD||University of Utah|
|Principal Investigator:||Perry F Renshaw, MD, PhD, MBA||University of Utah|