Creatine for Treatment of Depression Associated With Type 2 Diabetes

00101803

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.

2017-08-01

2024-06-10

2024-06-10

Withdrawn

Early phase I

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 0, 'type': 'ACTUAL'}}

2024-06-11