Open-Label Creatine Study for Female Meth Users
| Status: | Recruiting |
|---|---|
| Conditions: | Depression, Depression, Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 13 - 55 |
| Updated: | 7/11/2015 |
| Start Date: | January 2012 |
| End Date: | December 2016 |
| Contact: | Tracy Hellem, RN, PhD(c) |
| Email: | tracy.hellem@hsc.utah.edu |
| Phone: | 801 587 1546 |
Open-Label Creatine Monohydrate Supplementation in Depressed Female Methamphetamine Users
Study Purposes and Objectives:
The objectives should be stated in such a way that the reader can determine the
appropriateness of the study design. If appropriate, state the specific hypotheses being
tested and/or study aims. Use lay language.
Methamphetamine use is of great concern in the state of Utah because it's the primary drug
of threat in the state, and is the primary drug of choice among females between the ages of
18 and 24. 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.
The objectives should be stated in such a way that the reader can determine the
appropriateness of the study design. If appropriate, state the specific hypotheses being
tested and/or study aims. Use lay language.
Methamphetamine use is of great concern in the state of Utah because it's the primary drug
of threat in the state, and is the primary drug of choice among females between the ages of
18 and 24. 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.
Inclusion Criteria:
1. Must be female
2. Must be between the ages of 13 and 55 years
3. Methamphetamine must be primary drug of choice
4. Must have used methamphetamine within the last 6 months
5. For participants > 18 years of age, must have a Hamilton Depression Rating Scale
(HDRS or HAM-D) score of > 17
6. For participants < 18 years of age, must have a Children Depression Rating Scale
(CDRS) score of > 40
7. Must be able to give informed consent
Exclusion Criteria:
1. Significant current or past medical conditions, such as cardiovascular, renal or
endocrine disorders
2. DSM-IV diagnosis of bipolar disorder, schizophrenia, or schizoaffective disorder
3. Known pregnancy or positive urine HCG test
4. Current serious homicidal or suicidal risk
5. Young Mania Rating Scale (YMRS) score > 7
6. Inability to comply with the protocol
7. Contraindication to an MR scan
8. Positive HIV test
9. Known sensitivity to creatine monohydrate
Inclusion criteria for healthy comparison group:
1. Must be female
2. Must be between the ages of 13 and 55 years
3. Must be able to give informed consent
Exclusion criteria for healthy comparison group:
1. Significant current medical illness
2. DSM-IV disorder identified by the SCID (to include bipolar I, bipolar II, bipolar
NOS, major depressive disorder, dysthymia disorder, depressive disorder NOS, primary
psychotic symptoms, substance use disorders, and anxiety disorders)
3. Known pregnancy or positive urine HCG test
4. Contraindication to an MR scan
5. Inability to comply with the protocol
6. Positive urine drug screen (unless it is positive for a low dose prescription opiate
that is taken as prescribed)
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