Trial Outcomes & Findings for Creatine as a Treatment Option for Depression in Methamphetamine Using Females (NCT NCT01514630)
NCT ID: NCT01514630
Last Updated: 2015-06-29
Results Overview
Eight weeks of oral creatine supplementation will result in improvements in Hamilton Depression Rating Scale (HAMD) in female methamphetamine users. HAMD scoring is based on 17 items. Minimum score is 0 and maximum 52. A score of 0-7 is considered to be normal. Scores of 20 or higher indicate moderate or severe depression. 0-7 = Normal 8-13 = Mild Depression 14-18 = Moderate Depression 19-22 = Severe Depression ≥ 23 = Very Severe Depression
COMPLETED
PHASE4
14 participants
Over the course of eight weeks. Depression rating scores will be measured weekly for eight weeks for each subject enrolled.
2015-06-29
Participant Flow
Participant milestones
| Measure |
Creatine Monohydrate
14 female depressed methamphetamine users received 5 grams of creatine monohydrate daily for eight weeks. Participants were seen twice weekly after creatine was initiated. All participants met SCID-I/P criteria for lifetime methamphetamine dependence or for current methamphetamine dependence. After consent was obtained, the principal investigator administered the SCID-I/P and HAMD, and if a female met SCID-I/P criteria and scored \> 15 on the HAMD, the following additional screening data were collected: Beck Anxiety Inventory, C-SSRS , vital signs, concomitant medications, self-report drug use over the past 48 hours for cigarettes, alcohol, cocaine, methamphetamine, marijuana, heroin and prescription controlled substances, urine drug screen for methamphetamine, opiates, benzodiazepines, marijuana and cocaine, pregnancy testing and attendance in outpatient treatment and/or 12 step programs.
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|---|---|
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Overall Study
STARTED
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14
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Overall Study
COMPLETED
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11
|
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Overall Study
NOT COMPLETED
|
3
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Creatine as a Treatment Option for Depression in Methamphetamine Using Females
Baseline characteristics by cohort
| Measure |
Creatine Monohydrate
n=14 Participants
14 female depressed methamphetamine users will receive 5 grams of creatine monohydrate daily for eight weeks.
Creatine monohydrate: Five grams of creatine monohydrate will be administered for eight weeks.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
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14 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
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0 Participants
n=5 Participants
|
|
Age, Continuous
|
37.4 years
STANDARD_DEVIATION 9.9 • n=5 Participants
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Sex: Female, Male
Female
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14 Participants
n=5 Participants
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Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
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Region of Enrollment
United States
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14 participants
n=5 Participants
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PRIMARY outcome
Timeframe: Over the course of eight weeks. Depression rating scores will be measured weekly for eight weeks for each subject enrolled.Eight weeks of oral creatine supplementation will result in improvements in Hamilton Depression Rating Scale (HAMD) in female methamphetamine users. HAMD scoring is based on 17 items. Minimum score is 0 and maximum 52. A score of 0-7 is considered to be normal. Scores of 20 or higher indicate moderate or severe depression. 0-7 = Normal 8-13 = Mild Depression 14-18 = Moderate Depression 19-22 = Severe Depression ≥ 23 = Very Severe Depression
Outcome measures
| Measure |
Creatine Monohydrate
n=11 Participants
14 female depressed methamphetamine users will receive 5 grams of creatine monohydrate daily for eight weeks.
Creatine monohydrate: Five grams of creatine monohydrate will be administered for eight weeks.
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|---|---|
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HAMD Rating Scores
week 2
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10.71 Units on a scale
Standard Deviation 4.75
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HAMD Rating Scores
Baseline
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16.86 Units on a scale
Standard Deviation 3.40
|
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HAMD Rating Scores
week 3
|
9.81 Units on a scale
Standard Deviation 4.45
|
|
HAMD Rating Scores
week 4
|
7.33 Units on a scale
Standard Deviation 2.74
|
|
HAMD Rating Scores
week 5
|
8.35 Units on a scale
Standard Deviation 4.12
|
|
HAMD Rating Scores
week 6
|
7.73 Units on a scale
Standard Deviation 3.88
|
|
HAMD Rating Scores
week 7
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6.28 Units on a scale
Standard Deviation 5.07
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HAMD Rating Scores
week 8
|
7.36 Units on a scale
Standard Deviation 4.59
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Adverse Events
Creatine Monohydrate
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Creatine Monohydrate
n=14 participants at risk
14 female depressed methamphetamine users will receive 5 grams of creatine monohydrate daily for eight weeks.
Creatine monohydrate: Five grams of creatine monohydrate will be administered for eight weeks.
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|---|---|
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General disorders
Cold and flu symptoms
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71.4%
10/14
|
|
Gastrointestinal disorders
Indigestion
|
7.1%
1/14
|
|
General disorders
Polydipsia
|
7.1%
1/14
|
|
General disorders
Headache
|
7.1%
1/14
|
|
General disorders
Swelling in Hands
|
7.1%
1/14
|
|
Gastrointestinal disorders
Diarrhea
|
28.6%
4/14
|
|
Gastrointestinal disorders
Stomach Discomfort
|
21.4%
3/14
|
|
General disorders
Numbness and Tingling in hands
|
7.1%
1/14
|
|
General disorders
Muscle Cramps
|
14.3%
2/14
|
|
General disorders
Lightheaded
|
7.1%
1/14
|
|
General disorders
Nausea
|
7.1%
1/14
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Additional Information
Perry Renshaw, MD, PhD, MBA
The Brain Institute of the University of Utah
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place