Creatine for treatment of depression in type 2 diabetes

Simple Summary

The purpose of the study is to determine whether 12 weeks of dietary augmentation with oral 5g creatine daily depressive symptoms in persons with type II 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

Participant Reimbursement

$25 at the screening visit$65 at the baseline visit (includes $50 compensation for MRI)$15 at each of the treatment phase visits (weeks 1, 2, 4, 8) $65 at the treatment week 12 (includes $50 compensation for MRI)$10 at each of the two follow-up visits (weeks 14, 16; total $20)