Creatine for Treatment of Depression Associated With Type 2 Diabetes

• Status: Recruiting
• Trial end date: 2022-11-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Utah

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