Depression Clinical Trial
Official title:
Creatine as a Treatment Option for Depression in Methamphetamine Using Females
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 |
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.
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | The Brain Institute of the University of Utah | Salt Lake City | Utah |
Lead Sponsor | Collaborator |
---|---|
Perry Renshaw |
United States,
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 |
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