Creatine for treatment of depression in type 2 diabetes

Principal Investigator: Perry Renshaw
Keywords: Depression , Creatine , Diabetes Department: Adult Psychiatry
IRB Number: 00101803 Co Investigator: Lindsay Scholl
Specialty: Psychiatry
Sub Specialties: Mood Disorders
Recruitment Status: Recruiting

Contact Information

Lindsay Scholl
lindsay.scholl@utah.edu
8013864773

Brief Summary

The purpose of the study is to determine whether 12 weeks of dietary augmentation with oral 5g creatine daily reduces depressive symptoms in persons with type 1 or type 2 diabetes mellitus as measured by Hamilton Rating Scale for Depression (HAM-D). Secondary clinical outcomes will include evaluation of changes in glycemic control as measured by hemoglobin A1c scores and in diabetes self-care as measured by the Diabetes Self-Management Questionnaire (DSMQ).  We also propose to examine changes in brain metabolism inferred from phosphorus-31 magnetic resonance spectroscopy (31P-MRS).

Inclusion Criteria

- Women age 20-64

- Current diagnosis of Major Depressive Disorder identified by the SCID-5-RV

- Current HAM-D score of > 16

-Current type 1 or type 2 diabetes as confirmed either by A1c > 6.5 or by clinical history and concurrent use of antidiabetic medications (metformin, sulfonylureas, insulin, or other commonly used agents).

- Diabetes type 1 or 2 present for at least one year

- Minimal risk of pregnancy based on post-menopausal status, hysterectomy, use of intrauterine contraceptive device or subdermal contraceptive implant, or regular use of two forms of as-needed birth control

Exclusion Criteria

- Current use of psychotropic agents except for as needed use of benzodiazepines or other hypnotics for anxiety or the use of trazodone < 200mg total daily dose for insomnia

- 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 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