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Creatine as a Treatment Option for Depression in Methamphetamine Using Females

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. Identifier: NCT01514630
Recruitment Status : Completed
First Posted : January 23, 2012
Results First Posted : June 29, 2015
Last Update Posted : June 29, 2015
Information provided by (Responsible Party):
Perry Renshaw, University of Utah

Brief 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.

Condition or disease Intervention/treatment Phase
Depression Substance Abuse Substance Use Neuroimaging Dual Diagnosis Drug: Creatine monohydrate Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Creatine as a Treatment Option for Depression in Methamphetamine Using Females
Study Start Date : January 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Methamphetamine

Arm Intervention/treatment
Experimental: Creatine monohydrate
14 female depressed methamphetamine users received 5 grams of creatine monohydrate daily for eight weeks.
Drug: Creatine monohydrate
Five grams of creatine monohydrate will be administered for eight weeks.

Primary Outcome Measures :
  1. HAMD Rating Scores [ Time Frame: Over the course of eight weeks. Depression rating scores will be measured weekly for eight weeks for each subject enrolled. ]

    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

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 64 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT01514630

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United States, Utah
The Brain Institute of the University of Utah
Salt Lake City, Utah, United States, 84108
Sponsors and Collaborators
Perry Renshaw
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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

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Perry Renshaw, Professor of Psychiatry, University of Utah Identifier: NCT01514630     History of Changes
Other Study ID Numbers: 60398
First Posted: January 23, 2012    Key Record Dates
Results First Posted: June 29, 2015
Last Update Posted: June 29, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
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Depressive Disorder
Substance-Related Disorders
Behavioral Symptoms
Mood Disorders
Mental Disorders
Chemically-Induced Disorders
Central Nervous System Stimulants
Physiological Effects of Drugs
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors