The BIO-K Study: A Single-Arm, Open-Label, Biomarker Development Clinical Trial of Ketamine for Non-Psychotic Unipolar Major Depression and Bipolar I or II Depression.

This single-group study administers three intravenous ketamine hydrochloride infusions (0.5 mg/kg, each infused over 100 minutes) to adults with treatment-resistant major depression or bipolar depression and measures depressive symptom response.

Blood samples collected before and after treatment will be used to develop and test predictive and change biomarkers, including assessment of mTOR target engagement in white blood cells and composite blood-based markers of ketamine antidepressive effects.