Creatine for Treatment of Depression Associated With Type 2 Diabetes

Phase 4

Withdrawn

• Conditions: Major Depressive Disorder
• Interventions: Drug: Creatine Monohydrate

• Registration Number: NCT03202095
• Lead Sponsor: University of Utah

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.

Study Timeline

• Study First Submitted: 2017-06-26
• Study First Submitted QC: 2017-06-26
• Study First Posted: 2017-06-28
• Study Start: 2017-08-01
• Status Verified: 2024-06
• Primary Completion: 2024-06-10
• Study Completion: 2024-06-10
• Last Update Submitted: 2024-06-10
• Last Update Posted: 2024-06-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Open Label Treatment with Creatine	Creatine Monohydrate	5 grams daily of oral creatine monohydrate powde

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Hamilton Depression Rating Scale	12 weeks	The purpose of this study is to determine whether 12 weeks of dietary creatine augmentation with oral 5 g creatine daily reduces hypoxia-related depressive symptoms measured by the 17-item Hamilton Depression Rating Scale (HAM-D) in women with SSRI or SNRI resistant depression.

Trial Locations

Locations (1)

University of Utah; 🇺🇸 Salt Lake City, Utah, United States