Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Open-Label Creatine Study for Female Meth Users

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02189915
Recruitment Status : Terminated (Received funding for the next phase of the study)
First Posted : July 15, 2014
Results First Posted : May 20, 2016
Last Update Posted : May 20, 2016
Sponsor:
Information provided by (Responsible Party):
Perry Renshaw, University of Utah

Tracking Information
First Submitted Date  ICMJE July 11, 2014
First Posted Date  ICMJE July 15, 2014
Results First Submitted Date  ICMJE February 16, 2016
Results First Posted Date  ICMJE May 20, 2016
Last Update Posted Date May 20, 2016
Study Start Date  ICMJE January 2012
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 13, 2016)
Depression Rating Scores [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 11, 2014)
Depression Rating Scores [ Time Frame: 8-week ]
Hamilton Depression Rating Scale scores will be measured twice weekly during the 8-week intervention phase.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 13, 2016)
Phosphocreatine Levels Measured by Magnetic Resonance Spectroscopy [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2014)
Changes in neurochemistry measures by magnetic resonance spectroscopy [ Time Frame: 8 weeks ]
PCr and beta NTP will be measured pre- and post-creatine treatment.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Open-Label Creatine Study for Female Meth Users
Official Title  ICMJE Open-Label Creatine Monohydrate Supplementation in Depressed Female Methamphetamine Users
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Depression
  • Dual Diagnosis
  • Substance Use
Intervention  ICMJE Drug: Creatine monohydrate
Study Arms  ICMJE Experimental: Creatine monohydrate
Intervention: Drug: Creatine monohydrate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 14, 2015)
14
Original Estimated Enrollment  ICMJE
 (submitted: July 11, 2014)
40
Actual Study Completion Date  ICMJE October 2015
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Exclusion criteria for healthy comparison group:

  1. Significant current medical illness
  2. 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)
  3. Known pregnancy or positive urine HCG test
  4. Contraindication to an MR scan
  5. Inability to comply with the protocol
  6. Positive urine drug screen (unless it is positive for a low dose prescription opiate that is taken as prescribed)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 13 Years to 55 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02189915
Other Study ID Numbers  ICMJE 53737
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Perry Renshaw, University of Utah
Study Sponsor  ICMJE Perry Renshaw
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Perry Renshaw, MD, PhD, MBA University of Utah
PRS Account University of Utah
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP