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Creatine for Treatment of Depression Associated With Type 2 Diabetes

Primary Purpose

Major Depressive Disorder

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Creatine Monohydrate
Sponsored by
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Depression, Type 2 Diabetes, Creatine, Diabetes

Eligibility Criteria

20 Years - 64 Years (Adult)FemaleDoes not accept 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

Sites / Locations

  • University of UtahRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Open Label Treatment with Creatine

Arm Description

5 grams daily of oral creatine monohydrate powde

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
June 26, 2017
Last Updated
April 22, 2021
Sponsor
University of Utah
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1. Study Identification

Unique Protocol Identification Number
NCT03202095
Brief Title
Creatine for Treatment of Depression Associated With Type 2 Diabetes
Official Title
Creatine for Treatment of Depression Associated With Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
November 1, 2022 (Anticipated)
Study Completion Date
November 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Depression, Type 2 Diabetes, Creatine, Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Open Label Treatment with Creatine
Arm Type
Experimental
Arm Description
5 grams daily of oral creatine monohydrate powde
Intervention Type
Drug
Intervention Name(s)
Creatine Monohydrate
Intervention Description
5 grams daily of oral creatine monohydrate powder.
Primary Outcome Measure Information:
Title
Change from Baseline in Hamilton Depression Rating Scale
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lindsay Scholl, BS
Phone
801-386-4773
Email
lindsay.scholl@utah.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Perry F Renshaw, MD, PhD, MBA
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lindsay Scholl, BS
Phone
801-386-4773
Email
lindsay.scholl@utah.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Creatine for Treatment of Depression Associated With Type 2 Diabetes

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