The Bio-K Study: Biomarker Development Ketamine Clinical Trial for Unipolar and Bipolar I or II Depression

The purpose of the Bio-K study is to find out if the medication known as ketamine can help the symptoms of depression in people living with major depression, bipolar disorder I or II. More specifically, we want to find out if some people have better response to ketamine treatments than others and if we can predict that response (biomarkers). Ketamine is approved by the Food and Drug Administration (FDA) but we will use it for a non-FDA (open-label) approved reason (depression).

Participants will be between 18-65 years of age with a diagnosis of major depressive disorder, bipolar I or bipolar II disorder and have treatment resistant depression, as defined by a failure of two previous antidepressant or mood stabilizing treatments within the current depressive episode. They must meet study criteria for treatment resistant depression, be receiving treatment for their psychiatric care and have no current problems with substance abuse or dependence.

The Bio-K study consists of five (5) study visits. The first visit consists of an in-person screening that will take about 1-2 hours to assess eligibility with a clinical evaluation and mental health assessments. Visits 2-4 will consist of three 40-100 minutes intra-venous (IV) ketamine infusions over the course of eight days. Each infusion visit will take approximately 2-4 hours. The last visit will be about 30 minutes to one hour and will ask about mental health status and experiences with the infusions. Participants will be asked to complete blood draws, ECG, urine tests, and clinical assessments.

The Bio-K study is a collaboration between eight different sites that are part of the National Network of Depression Centers (NNDC). A team of clinicians and researchers from the University of Michigan site, including the University of Michigan Depression Center, Department of Psychiatry and Anesthesiology, are partnering together to conduct the study.

Dr. Sagar Parikh is the Site Principal Investigator and Drs. Daniel Maixner, Brendon Watson, Karina Drake, Vijay Tarnal, Srijan Sen, and John Greden are Co-Investigators.

This study has received approval from: IRBMED HUM00136106.