Creatine for Treatment of Depression Associated With Type 2 Diabetes



Status:Recruiting
Conditions:Depression, Depression, Major Depression Disorder (MDD), Diabetes
Therapuetic Areas:Endocrinology, Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:20 - 64
Updated:10/13/2018
Start Date:August 1, 2017
End Date:November 1, 2019
Contact:Lindsay Scholl, BS
Email:lindsay.scholl@utah.edu
Phone:801-386-4773

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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.

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.

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
We found this trial at
1
site
201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
Phone: 801-386-4773
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