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Trial record 82 of 1053 for:    "Depressive Disorder" [DISEASE] AND Rating AND Hamilton Depression Rating Scale

Creatine for Treatment of Depression Associated With Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT03202095
Recruitment Status : Recruiting
First Posted : June 28, 2017
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
Perry Renshaw, 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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: Creatine Monohydrate Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Creatine for Treatment of Depression Associated With Type 2 Diabetes
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : November 1, 2019
Estimated Study Completion Date : November 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Open Label Treatment with Creatine Drug: Creatine Monohydrate
5 grams daily of oral creatine monohydrate powder.




Primary Outcome Measures :
  1. Change from Baseline in Hamilton Depression Rating Scale [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03202095


Contacts
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Contact: Lindsay Scholl, BS 801-386-4773 lindsay.scholl@utah.edu

Locations
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United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84108
Contact: Lindsay Scholl, BS    801-386-4773    lindsay.scholl@utah.edu   
Sponsors and Collaborators
University of Utah
Investigators
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Principal Investigator: Perry F Renshaw, MD, PhD, MBA University of Utah

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Responsible Party: Perry Renshaw, MD, PhD, MBA, University of Utah
ClinicalTrials.gov Identifier: NCT03202095     History of Changes
Other Study ID Numbers: 00101803
First Posted: June 28, 2017    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Perry Renshaw, University of Utah:
Depression
Type 2 Diabetes
Creatine
Diabetes

Additional relevant MeSH terms:
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Depression
Depressive Disorder
Depressive Disorder, Major
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Behavioral Symptoms
Mood Disorders
Mental Disorders