Back to resultsOpen-Label Creatine Study for Female Meth Users
Primary Purpose
Depression, Dual Diagnosis, Substance Use
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Creatine monohydrate
Sponsored by
About this trial
This is an interventional treatment trial for Depression
Eligibility Criteria
Inclusion Criteria:
- Must be female
- Must be between the ages of 13 and 55 years
- Methamphetamine must be primary drug of choice
- Must have used methamphetamine within the last 6 months
- For participants > 18 years of age, must have a Hamilton Depression Rating Scale (HDRS or HAM-D) score of > 17
- For participants < 18 years of age, must have a Children Depression Rating Scale (CDRS) score of > 40
- Must be able to give informed consent
Exclusion Criteria:
- Significant current or past medical conditions, such as cardiovascular, renal or endocrine disorders
- DSM-IV diagnosis of bipolar disorder, schizophrenia, or schizoaffective disorder
- Known pregnancy or positive urine HCG test
- Current serious homicidal or suicidal risk
- Young Mania Rating Scale (YMRS) score > 7
- Inability to comply with the protocol
- Contraindication to an MR scan
- Positive HIV test
- Known sensitivity to creatine monohydrate
Inclusion criteria for healthy comparison group:
- Must be female
- Must be between the ages of 13 and 55 years
- Must be able to give informed consent
Exclusion criteria for healthy comparison group:
- Significant current medical illness
- 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)
- Known pregnancy or positive urine HCG test
- Contraindication to an MR scan
- Inability to comply with the protocol
- Positive urine drug screen (unless it is positive for a low dose prescription opiate that is taken as prescribed)
Sites / Locations
- University of Utah
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Creatine monohydrate
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02189915
Brief Title
Open-Label Creatine Study for Female Meth Users
Official Title
Open-Label Creatine Monohydrate Supplementation in Depressed Female Methamphetamine Users
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Terminated
Why Stopped
Received funding for the next phase of the study
Study Start Date
January 2012 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Perry Renshaw
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Dual Diagnosis, Substance Use
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Creatine monohydrate
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Creatine monohydrate
Primary Outcome Measure Information:
Title
Depression Rating Scores
Description
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
Secondary Outcome Measure Information:
Title
Phosphocreatine Levels Measured by Magnetic Resonance Spectroscopy
Description
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Must be female
Must be between the ages of 13 and 55 years
Methamphetamine must be primary drug of choice
Must have used methamphetamine within the last 6 months
For participants > 18 years of age, must have a Hamilton Depression Rating Scale (HDRS or HAM-D) score of > 17
For participants < 18 years of age, must have a Children Depression Rating Scale (CDRS) score of > 40
Must be able to give informed consent
Exclusion Criteria:
Significant current or past medical conditions, such as cardiovascular, renal or endocrine disorders
DSM-IV diagnosis of bipolar disorder, schizophrenia, or schizoaffective disorder
Known pregnancy or positive urine HCG test
Current serious homicidal or suicidal risk
Young Mania Rating Scale (YMRS) score > 7
Inability to comply with the protocol
Contraindication to an MR scan
Positive HIV test
Known sensitivity to creatine monohydrate
Inclusion criteria for healthy comparison group:
Must be female
Must be between the ages of 13 and 55 years
Must be able to give informed consent
Exclusion criteria for healthy comparison group:
Significant current medical illness
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)
Known pregnancy or positive urine HCG test
Contraindication to an MR scan
Inability to comply with the protocol
Positive urine drug screen (unless it is positive for a low dose prescription opiate that is taken as prescribed)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Perry Renshaw, MD, PhD, MBA
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Open-Label Creatine Study for Female Meth Users
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