Major Depressive Disorder
Conditions
Keywords
Depression, Type 2 Diabetes, Creatine, Diabetes
Brief summary
The investigators hypothesize that the administration of a widely available, naturally occurring dietary supplement, creatine monohydrate, will reduce the severity of depression in individuals with type 2 diabetes. The purpose of this study is to determine whether 12 weeks of creatine supplementation is an effective treatment for depression in individuals with type 2 diabetes.
Detailed description
Depression is a debilitating illness associated with diminished quality of life and significant personal and societal costs. Depression is twice as common in those with type 2 diabetes compared to the general population. Antidepressants are commonly prescribed as treatment for depression; however, they may not be the optimal treatment for people with type 2 diabetes. Creatine has been shown to decrease symptoms of depression in many types of individuals when used over the course of 8 weeks or more. The purpose of this study is to investigate whether creatine can decrease symptoms of depression in individuals with type 2 diabetes when taken daily for 12 weeks. This study also investigates how creatine impacts brain chemistry as creatine decreases depressive symptoms.
Interventions
DRUGCreatine Monohydrate
5 grams daily of oral creatine monohydrate powder.
Sponsors
University of Utah
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Current diagnosis of Major Depressive Disorder identified by the SCID-5-RV * Current HAM-D score of \> 16 * Current type 2 diabetes (as confirmed by clinical history and baseline glycosylated hemoglobin percentage (HgA1c) \> 6.5. * Diabetes type II present for at least one year
Exclusion criteria
* Diagnosis of bipolar disorder, schizophrenia, or schizoaffective disorder, identified by the SCID-5-RV * History of or current diagnosis of acute kidney injury (AKI), chronic kidney disease (CKD) or end-stage renal disease (ESRD) * Electrolyte disturbance (hypokalemia, hyperkalemia, hyponatremia, or hypernatremia) on screening basic metabolic panel * History of cardiac disease or QTc \>500ms on screening EKG * History of diabetic ketoacidosis or hyperosmolar hyperglycemic state * History of seizure disorder * Current serious suicide risk identified by the Columbia Severity Suicide Rating Scale * Positive pregnancy test * Breastfeeding * Contraindication to an MRI scan * Current incarceration
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Hamilton Depression Rating Scale | 12 weeks | The purpose of this study is to determine whether 12 weeks of dietary creatine augmentation with oral 5 g creatine daily reduces hypoxia-related depressive symptoms measured by the 17-item Hamilton Depression Rating Scale (HAM-D) in women with SSRI or SNRI resistant depression. |
Countries
United States
Outcome results
None listed