The BIO-K Study: A Single-Arm, Open-Label,... — Clinical Trial Details

Participants

Ages

18 – 65

Sexes

Male & Female

BMI

Psychosis History

Ability to provide informed consent
Current psychiatric inpatient (voluntary only) or outpatient treatment
Meets DSM-5 diagnostic criteria for major depressive disorder, bipolar I disorder, or bipolar II disorder
Patient Health Questionnaire (PHQ-9) total score > 15 at screening and at baseline (just prior to first acute phase ketamine infusion)
Treatment-resistant depression, defined by failure of at least two previous antidepressant or mood stabilizing treatments within the current depressive episode
Failed treatments can include pharmacotherapy at adequate dose for ≥8 weeks or an acute series of ≥6 administrations of ECT
Ability to pass a comprehension assessment related to effects of ketamine and trial objectives and criteria

Diagnosis of schizophrenia, schizoaffective disorder, or active psychotic symptoms
Ongoing prescription of >4 mg lorazepam equivalents daily, or morning dosing of any benzodiazepine at time of assessment
Currently undergoing ECT, transcranial magnetic stimulation, vagal nerve stimulation, or deep brain stimulation as acute or maintenance depression treatment
Any active or unstable medical condition judged by study psychiatrist to confer excessive medical risk
Use or abuse of methamphetamine, cocaine, cannabis, or stimulants (prescribed or illicit) within past 12 months
Any current abuse or dependence of alcohol or drugs (excluding nicotine and caffeine); persons in complete remission >1 year allowed
History of traumatic brain injury with loss of consciousness
Developmental delay, intellectual disability, or mental retardation
Clinical or self-reported delirium, encephalopathy, or related diagnosis within prior 12 months
Cognitive disorder (mild or major, per DSM-5)
Prior participation in another ketamine study for depression within prior 6 months
History of poor antidepressant response to or poor tolerability of ketamine when previously administered for depression
History of hypothyroidism unless on stable thyroid medication and asymptomatic for 6 months
Significant unstable medical condition
Hepatic insufficiency (AST or ALT ≥2.5× ULN within 1 year), past liver transplant, or clinical cirrhosis
Pregnancy or nursing
Prisoners
Involuntary psychiatric hospitalization

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.