Creatine for Treatment of Depression Associated With Type 2 Diabetes

NCT ID: NCT03202095

Last Updated: 2024-06-11

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-01
• Study Completion Date: 2024-06-10

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.

Conditions

Major Depressive Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Open Label Treatment with Creatine

5 grams daily of oral creatine monohydrate powde

Group Type: EXPERIMENTAL

Creatine Monohydrate

Intervention Type: DRUG

5 grams daily of oral creatine monohydrate powder.

Interventions

Creatine Monohydrate

5 grams daily of oral creatine monohydrate powder.

Intervention Type: DRUG

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Perry Renshaw

MD, PhD, MBA

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Perry F Renshaw, MD, PhD, MBA

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

University of Utah

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

00101803

Identifier Type: -

Identifier Source: org_study_id