Open-Label Creatine Monohydrate Supplementation in Depressed Female Methamphetamine Users
Methamphetamine (MA) use is of great concern in the state of Utah (UT) because it is the primary drug threat in the state, and accounts for 15.6% of substance abuse treatment admissions. It UT, MA is more widely abused than heroin, cocaine, or prescription drugs, and it's the primary drug of choice in females between the ages of 18 and 24 years. Depression among females is also a great concern in UT. Females are prescribed antidepressants at a rate of more than twice that of males. Consistent research findings have reported a prevalence of major depressive disorder (MDD) in female MA users as being two to three times greater than males. There are limited treatment options for treating MDD in female MA users. Limited studies of creatine monohydrate supplementation in adolescent females with MDD who have not responded to SSRI-treatment suggest that creatine is safe and reduces depressive symptoms, but there are no reports of creatine supplementation in depressed female MA users.
The primary hypothesis of the study is that eight weeks of oral creatine supplementation will result in improvements in depression rating scores in female MA users. Secondary hypotheses include the following: 1) creatine supplementation will result in a decrease in the number of positive MA screens; 2) NAA and Cr concentrations will increase after eight weeks of oral creatine supplementation; and 3) PCr/β-NTP levels in the frontal lobe using 31P MRS will increase after eight weeks of creatine monohydrate oral supplementation.
Drug: Creatine monohydrate
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Open-Label Creatine Monohydrate Supplementation in Depressed Female Methamphetamine Users|
- Depression rating scores [ Time Frame: Over the course of eight weeks. Depression rating scores will be measured twice weekly for eight weeks for each subject enrolled. ] [ Designated as safety issue: No ]Eight weeks of oral creatine supplementation will result in improvements in depression rating scores in female methamphetamine users.
|Study Start Date:||March 2012|
|Estimated Study Completion Date:||January 2014|
|Estimated Primary Completion Date:||February 2013 (Final data collection date for primary outcome measure)|
Experimental: Creatine monohydrate
Twenty female depressed methamphetamine users will receive 5 grams of creatine monohydrate daily for eight weeks.
Drug: Creatine monohydrate
Five grams of creatine monohydrate will be administered for eight weeks.
|Contact: Tracy Hellem, RNemail@example.com|
|United States, Utah|
|The Brain Institute of the University of Utah||Recruiting|
|Salt Lake City, Utah, United States, 84108|
|Contact: Tracy Hellem, RN 801-587-1456 firstname.lastname@example.org|
|Principal Investigator:||Perry Renshaw, MD, PhD, MBA||The Brain Institute of the University of Utah|