Open-Label Creatine Study for Female Meth Users

Depression Clinical Trial

Official title:

Open-Label Creatine Monohydrate Supplementation in Depressed Female Methamphetamine Users

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02189915
• Other study ID #: 53737
• Status: Terminated
• Phase: N/A
• First received: July 11, 2014
• Last updated: May 14, 2015
• Start date: January 2012
• Est. completion date: December 2016

Study information

• Verified date: May 2015
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: December 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 13 Years to 55 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Dual Diagnosis
• Substance Use

Intervention

Drug:
• Creatine monohydrate

Locations

Country	Name	City	State
United States	University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Perry Renshaw

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depression rating scores	Hamilton Depression Rating Scale scores will be measured twice weekly during the 8-week intervention phase.	8-week	No
Secondary	Changes in neurochemistry measures by magnetic resonance spectroscopy	PCr and beta NTP will be measured pre- and post-creatine treatment.	8 weeks	No