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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

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.


Condition or disease Intervention/treatment Phase
Depression Dual Diagnosis Substance Use Drug: Creatine monohydrate Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-Label Creatine Monohydrate Supplementation in Depressed Female Methamphetamine Users
Study Start Date : January 2012
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Creatine monohydrate Drug: Creatine monohydrate



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02189915


Locations
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United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84108
Sponsors and Collaborators
Perry Renshaw
Investigators
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Principal Investigator: Perry Renshaw, MD, PhD, MBA University of Utah
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Responsible Party: Perry Renshaw, Professor of Psychiatry, University of Utah
ClinicalTrials.gov Identifier: NCT02189915    
Other Study ID Numbers: 53737
First Posted: July 15, 2014    Key Record Dates
Results First Posted: May 20, 2016
Last Update Posted: May 20, 2016
Last Verified: April 2016
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms