Status:
TERMINATED
Open-Label Creatine Study for Female Meth Users
Lead Sponsor:
Perry Renshaw
Conditions:
Depression
Dual Diagnosis
Eligibility:
FEMALE
13-55 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2015
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT02189915
Start Date
January 1 2012
End Date
October 1 2015
Last Update
May 20 2016
Active Locations (1)
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1
University of Utah
Salt Lake City, Utah, United States, 84108