Creatine for Treatment of Depression Associated With Type 2 Diabetes

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.

• Creatine Monohydrate (Drug): 5 grams daily of oral creatine monohydrate powder.

Primary outcomes

• 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.

Sex: Female, ages: 20 Years to 64 Years

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

• Perry F Renshaw, MD, PhD, MBA, Principal investigator, University of Utah