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.

Diagnosis of schizophrenia, schizoaffective disorder, or active psychotic symptoms

Ongoing prescription of \> 4 mg lorazepam equivalents (total) daily, or morning dosing of any benzodiazepine at the time of assessment

Currently undergoing ECT, transcranial magnetic stimulation, vagal nerve stimulation, or deep brain stimulation as either an acute or maintenance treatment of depression

Any active or unstable medical condition judged by the study psychiatrist as conferring too great a level of medical risk to allow inclusion in the study

Use or abuse of methamphetamine, cocaine, cannabis, or stimulants (prescribed and illicit) within the past 12 months

Any current abuse or dependence of alcohol or drugs (excluding nicotine and caffeine) Note: Persons will be allowed to enroll in this study if their drug or alcohol abuse/dependence is in complete (not partial) and sustained (\> 1 year) remission

History of traumatic brain injury that resulted in loss of consciousness

Developmental delay, mental retardation, or intellectual disorder

Clinical or self-reported diagnosis of delirium, encephalopathy, or related clinical diagnosis within the prior 12 months

Cognitive disorder (mild and major categories, per DSM-5)

Prior participation in another study of ketamine for depression within the prior 6 months

History of either poor antidepressive response to or poor tolerability of ketamine (any route of administration) when previously administered for treating symptoms of depression

History of hypothyroidism unless taking a stable dose of thyroid medication and asymptomatic for 6 months

Significant unstable medical condition

Hepatic insufficiency (2.5 X upper limit of normal (ULN) for aspartate aminotransferase (AST) or ALT) within 1 year of consent, past liver transplant recipient, and/or clinical diagnosis of cirrhosis of the liver

Pregnancy, or nursing

Prisoners

Involuntary psychiatric hospitalization

What this study is about