Creatine Treatment for Female Adolescents With Depression Who Are Non-Responders to Fluoxetine or Escitalopram
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|ClinicalTrials.gov Identifier: NCT00851006|
Recruitment Status : Completed
First Posted : February 25, 2009
Results First Posted : January 13, 2015
Last Update Posted : May 12, 2017
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 of the study is that oral creatine supplementation will have a beneficial effect as adjunctive therapy in female adolescents with MDD who are non-responders to an adequate trial of the SSRIs Fluoxetine or Escitalopram.
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder||Drug: Creatine Monohydrate||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Adjunctive Creatine Treatment for Adolescent Females With Major Depressive Disorder Who Are Non-Responders to Fluoxetine or Escitalopram: A Magnetic Resonance Spectroscopy Study|
|Study Start Date :||April 2009|
|Primary Completion Date :||December 2012|
|Study Completion Date :||December 2012|
Experimental: Open-Label Creatine
Creatine Monohydrate 4 grams daily by mouth
Drug: Creatine Monohydrate
Creapure brand of creatine monohydrate
Other Name: Creapure
- Mean Children's Depression Rating Scale (CDRS-R) [Reference: Poznanski EO et al. Preliminary Studies of the Reliability and Validity of the Children's Depression Rating Scale. J Am Acad Child Psychiatry. 1984 Mar;23(2):191-7.] [ Time Frame: 8 weeks ]The CDRS-R is a 17-item scale, with items ranging from 1 to 5 or 1 to 7 (possible total score from 17 to 113), rated by a clinician via interviews with the child or parent. Scores ≥40 are indicative of depression, whereas scores ≤28 is often used to define remission
- 31-phosphorus Magnetic Resonance Spectroscopy Phosphocreatine Metabolite [ Time Frame: 8 weeks ]Phosphocreatine Metabolite is a phosphorylated creatine molecule that plays a role in the production of the energy in the body. Phosphocreatine (PCr) metabolite was quantified by calculating the ratio of PCr over total phosphorus resonance from 31-Phosphorus Magnetic Resonance Spectroscopy.
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): NCT00851006
|United States, Utah|
|University of Utah|
|Salt Lake City, Utah, United States, 84108|
|Principal Investigator:||Douglas G Kondo, MD||University of Utah|