Creatine as a Treatment Option for Depression in Methamphetamine Using Females

Depression Clinical Trial

Official title:

Creatine as a Treatment Option for Depression in Methamphetamine Using Females

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01514630
• Other study ID #: 60398
• Status: Completed
• Phase: Phase 4
• First received: January 12, 2012
• Last updated: June 9, 2015
• Start date: January 2013
• Est. completion date: February 2015

Study information

• Verified date: June 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

Methamphetamine (MA) is a psychostimulant drug with high abuse potential. MA can be smoked, snorted, injected or ingested orally to produce a release of high levels of dopamine into the brain and reduction of dopamine uptake. Its use results in feelings of pleasure, increased energy, and greater alertness lasting up to 12 hours. In 2010, the National Survey on Drug Use and Health reported that 353,000 Americans aged 12 or older reported being current MA users. Over the past decade MA use rates have fluctuated with current use rates on the decline; however, importantly, even though overall use rates are declining, use rates among males and females are approaching equal proportions. This use rate pattern is unlike other drugs of abuse, which typically demonstrate males using more than females. In some states, more females than males consider MA as their drug of choice. Namely, in a 2010 report in the state of Utah, more females were diagnosed with MA as a primary substance of abuse than males upon admission to treatment.

Depression and MA use are highly comorbid. The relationship between MA use and depression is likely bidirectional, with MA use causing changes in mood and being used as a self-medicating behavior to reduce symptoms of depression. Several studies have shown that depression rates are higher in MA-using females compared to their male counterparts. It is likely that neurobiological and psychosocial mechanisms contribute to increased incidence of depressive symptoms in females.

No clear treatment model exists to suggest how the comorbidity of depression and MA use is best managed. In studies of antidepressants for treatment of MA withdrawal and dependence, findings have suggested that antidepressants are ineffective for treating depressive symptoms.

Creatine is an organic acid occurring naturally in vertebrates, where it takes part in energy homeostasis in tissues with fluctuating energy demands. Exogenous creatine has been shown to increase brain concentrations of PCr. Neuroimaging studies of creatine have shown increased brain phosphocreatine (PCr) content with creatine administration. Therefore, we hypothesize that oral creatine administration will increase PCr levels and reduce depressive symptoms in a sample of depressed female MA users. This hypothesis will be tested by a within subjects design by giving depressed MA using females oral creatine for eight weeks and measuring PCr pre- and post-treatment with magnetic resonance spectroscopy. Moreover, depressive symptoms will be measured by administration of the Hamilton Depression Rating Scale twice weekly during the course of creatine treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: February 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 13 Years to 64 Years

Eligibility

Inclusion Criteria:

1. Female gender, ages 18-64 years inclusive

2. Diagnosis of MA dependence or abuse within the past 12 months, with MA preferred drug of abuse, identified by the SCID-I-RV

3. Current diagnosis of Major Depressive Disorder identified by the SCID-I-RV

4. Current HAM-D17 score of > 15

Exclusion Criteria:

1. Diagnosis of bipolar disorder, schizophrenia, or schizoaffective disorder, identified by the SCID-I-RV

2. History of or current diagnosis of renal disease, such as chronic renal failure, acute renal failure or end stage renal disease

3. Diabetes type I or II

4. Colitis or diverticulitis

5. Seizure disorder

6. Current serious suicide risk identified by the Columbia Severity Suicide Rating Severity

7. Current treatment with an antipsychotic, mood stabilizer, or antidepressant

8. Positive HIV test

9. Active Hepatitis C

10. Contraindication to magnetic resonance scan

Study Design

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Dual Diagnosis
• Neuroimaging
• Substance Abuse
• Substance Use

Intervention

Drug:
• Creatine monohydrate
Five grams of creatine monohydrate will be administered for eight weeks.

Locations

Country	Name	City	State
United States	The Brain Institute of the 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	HAMD Rating Scores	Eight weeks of oral creatine supplementation will result in improvements in Hamilton Depression Rating Scale (HAMD) in female methamphetamine users. HAMD scoring is based on 17 items. Minimum score is 0 and maximum 52. A score of 0-7 is considered to be normal. Scores of 20 or higher indicate moderate or severe depression.; 0-7 = Normal 8-13 = Mild Depression 14-18 = Moderate Depression 19-22 = Severe Depression; = 23 = Very Severe Depression	Over the course of eight weeks. Depression rating scores will be measured weekly for eight weeks for each subject enrolled.	No