Clinical trial NCT03202095: Creatine for Treatment of Depression Associated With Type 2 Diabetes
Official title: Creatine for Treatment of Depression Associated With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Major Depressive Disorder
Keywords: Depression
Type 2 Diabetes
Creatine
Diabetes
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2017-06-28
Enrollment: 0
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline in Hamilton Depression Rating Scale
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Utah
name: Perry F Renshaw, MD, PhD, MBA
role: PRINCIPAL_INVESTIGATOR
References: