Creatine for Treatment of Depression Associated With Type 2 Diabetes

Utah System of Higher Education (USHE)

Status and phase: Withdrawn; Phase 4

Conditions: Major Depressive Disorder

Treatments: Drug: Creatine Monohydrate

Study type: Interventional

Funder types: Other

Identifiers

NCT03202095

00101803

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Ages: 20 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Open Label Treatment with Creatine

Experimental group

Description:

5 grams daily of oral creatine monohydrate powde

Treatment:

Drug: Creatine Monohydrate