Creatine for Treatment of Depression Associated With Type 2 Diabetes

NCT03202095 | Withdrawn Phase 4 DMC FDA Drug

• 1 other identifier: 00101803
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Keywords

Depression; Type 2 Diabetes; Creatine; Diabetes

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Hamilton Depression Rating Scale

  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.

  12 weeks

Study Arms (1)

Open Label Treatment with Creatine

EXPERIMENTAL

5 grams daily of oral creatine monohydrate powde

Drug: Creatine Monohydrate

Interventions

Creatine Monohydrate DRUG

5 grams daily of oral creatine monohydrate powder.

Open Label Treatment with Creatine

Eligibility Criteria

• Age: 20 Years - 64 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84108, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depression; Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

Creatine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Guanidines; Amidines; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Perry F Renshaw, MD, PhD, MBA

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, MBA

Study Record Dates

• First Submitted: June 26, 2017
• First Posted: June 28, 2017
• Study Start: August 1, 2017
• Primary Completion: June 10, 2024
• Study Completion: June 10, 2024
• Last Updated: June 11, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)