Depression, Dual Diagnosis, Substance Use
Conditions
Brief summary
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.
Interventions
DRUGCreatine monohydrate
Sponsors
Perry Renshaw
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
13 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depression Rating Scores | 8-week | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Phosphocreatine Levels Measured by Magnetic Resonance Spectroscopy | 8 weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Creatine Monohydrate Creatine monohydrate | 14 |
| Total | 14 |
Baseline characteristics
| Characteristic | Creatine Monohydrate |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants |
| Age, Continuous | 37.4 years STANDARD_DEVIATION 9.9 |
| Region of Enrollment United States | 14 participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 14 / 14 |
| serious Total, serious adverse events | 0 / 14 |
Outcome results
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.
Time frame: 8-week
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Creatine Monohydrate Treatment | Depression Rating Scores | Baseline | 16.86 units on a scale | Standard Deviation 3.4 |
| Creatine Monohydrate Treatment | Depression Rating Scores | After 8 weeks of treatment | 7.36 units on a scale | Standard Deviation 4.59 |
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.
Time frame: 8 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Creatine Monohydrate Treatment | Phosphocreatine Levels Measured by Magnetic Resonance Spectroscopy | Baseline | 0.223 Phosphocreatine levels (unitless) | Standard Deviation 0.013 |
| Creatine Monohydrate Treatment | Phosphocreatine Levels Measured by Magnetic Resonance Spectroscopy | Post-treatment | 0.233 Phosphocreatine levels (unitless) | Standard Deviation 0.009 |