Creatine as a Treatment Option for Depression in Methamphetamine Using Females

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University of Utah
Sponsor:
Information provided by (Responsible Party):
Perry Renshaw, University of Utah
ClinicalTrials.gov Identifier:
NCT01514630
First received: January 12, 2012
Last updated: July 11, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Depression
Substance Abuse
Substance Use
Neuroimaging
Dual Diagnosis
Drug: Creatine monohydrate
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Creatine as a Treatment Option for Depression in Methamphetamine Using Females

Resource links provided by NLM:


Further study details as provided by University of Utah:

Primary Outcome Measures:
  • Depression rating scores [ Time Frame: Over the course of eight weeks. Depression rating scores will be measured weekly for eight weeks for each subject enrolled. ] [ Designated as safety issue: No ]
    Eight weeks of oral creatine supplementation will result in improvements in depression rating scores in female methamphetamine users.


Estimated Enrollment: 30
Study Start Date: January 2013
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Creatine monohydrate
Thirty female depressed methamphetamine users will receive 5 grams of creatine monohydrate daily for eight weeks.
Drug: Creatine monohydrate
Five grams of creatine monohydrate will be administered for eight weeks.

  Eligibility

Ages Eligible for Study:   13 Years to 64 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01514630

Contacts
Contact: Tracy Hellem, RN 801-587-1546 tracy.hellem@hsc.utah.edu

Locations
United States, Utah
The Brain Institute of the University of Utah Recruiting
Salt Lake City, Utah, United States, 84108
Contact: Tracy Hellem, RN    801-587-1456    tracy.hellem@hsc.utah.edu   
Sponsors and Collaborators
Perry Renshaw
Investigators
Principal Investigator: Tracy Hellem, RN The College of Nursing & Brain Institute, University of Utah
Study Director: Perry Renshaw, MD, PhD, MBA Department of Psychiatry, University of Utah
  More Information

No publications provided

Responsible Party: Perry Renshaw, Professor of Psychiatry, University of Utah
ClinicalTrials.gov Identifier: NCT01514630     History of Changes
Other Study ID Numbers: 60398
Study First Received: January 12, 2012
Last Updated: July 11, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mental Disorders
Mood Disorders
Methamphetamine
Adrenergic Agents
Adrenergic Uptake Inhibitors
Autonomic Agents
Central Nervous System Agents
Central Nervous System Stimulants
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sympathomimetics
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014