Open-Label Creatine Study for Female Meth Users

Open-Label Creatine Monohydrate Supplementation in Depressed Female Methamphetamine Users

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.

Study Overview

• Status: Terminated
• Conditions: Depression; Substance Use; Dual Diagnosis
• Intervention / Treatment: Drug: Creatine monohydrate

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84108
      • University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 55 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Creatine monohydrate	Drug: Creatine monohydrate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	8-week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	8 weeks

Collaborators and Investigators

• Sponsor: Perry Renshaw
• Investigators: Principal Investigator: Perry Renshaw, MD, PhD, MBA, University of Utah

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: July 11, 2014
• First Submitted That Met QC Criteria: July 11, 2014
• First Posted (Estimate): July 15, 2014

Study Record Updates

• Last Update Posted (Estimate): May 20, 2016
• Last Update Submitted That Met QC Criteria: April 13, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: 53737