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Received funding for the next phase of the study
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Creatine monohydrate | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Creatine monohydrate | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Depression Rating Scores | Hamilton Depression Rating Scale scores is used to assess the level of depression. The Hamilton Depression Rating Scale ranges from 0 to 50. A score of 0-7 is considered to be normal. A score of 8-13 indicates mild depression. A score of 14-18 indicates moderate depression. Scores higher than 19 indicate severe depression. | 8-week |
| Measure | Description | Time Frame |
|---|---|---|
| Phosphocreatine Levels Measured by Magnetic Resonance Spectroscopy | Phosphocreatine (PCr) was measured pre- and post-creatine treatment to assess changes in neurochemistry. Creatine treatment may increase brain intracellular PCr, and brain energy metabolism has been suggested to play a role in the pathophysiology of depression. Increased levels of PCr suggest reduced depressive symptoms. PCr levels are calculated using a ratio and remains unitless. |
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Inclusion Criteria:
Exclusion Criteria:
Inclusion criteria for healthy comparison group:
Exclusion criteria for healthy comparison group:
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| Name | Affiliation | Role |
|---|---|---|
| Perry Renshaw, MD, PhD, MBA | University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Utah | Salt Lake City | Utah | 84108 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Creatine Monohydrate Treatment | This study is an open label study, where all participants received Creatine monohydrate. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Creatine Monohydrate | Creatine monohydrate |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Depression Rating Scores | Hamilton Depression Rating Scale scores is used to assess the level of depression. The Hamilton Depression Rating Scale ranges from 0 to 50. A score of 0-7 is considered to be normal. A score of 8-13 indicates mild depression. A score of 14-18 indicates moderate depression. Scores higher than 19 indicate severe depression. | Posted | Mean | Standard Deviation | units on a scale | 8-week |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Creatine Monohydrate Treatment | This study is an open label study, where all participants received Creatine monohydrate. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Flu like symptoms | General disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Perry Renshaw, MD, PhD, MBA | The Brain Institute of the University of Utah | 801-587-1216 | perry.renshaw@hsc.utah.edu |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D003401 | Creatine |
| ID | Term |
|---|---|
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
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| 8 weeks |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Phosphocreatine Levels Measured by Magnetic Resonance Spectroscopy | Phosphocreatine (PCr) was measured pre- and post-creatine treatment to assess changes in neurochemistry. Creatine treatment may increase brain intracellular PCr, and brain energy metabolism has been suggested to play a role in the pathophysiology of depression. Increased levels of PCr suggest reduced depressive symptoms. PCr levels are calculated using a ratio and remains unitless. | Posted | Mean | Standard Deviation | Phosphocreatine levels (unitless) | 8 weeks |
|
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|
| 0 |
| 14 |
| 14 |
| 14 |
| Indigestion, Nausea | Gastrointestinal disorders |
|
| Numbness, tingling | Nervous system disorders |
|
| Swelling in hands | General disorders |
|
| Blurry vision | Eye disorders |
|
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| D000602 |
| Amino Acids, Peptides, and Proteins |