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.
Condition: Major Depression; Bipolar I Disorder; Bipolar II Disorder; Unipolar Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Intervention: Ketamine Hydrochloride
Intervention description: Subjects will receive three IV ketamine infusions at 0.5 mg/kg, infused over 100 minutes.
Intervention MeSH terms: Ketamine
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 75.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this research study is to find out if the medication known as ketamine can
      help the symptoms of depression. This drug is approved by the Food and Drug Administration
      (FDA) but the investigators will use it for a non-FDA approved reason (depression).
    

Eligibility criteria:

        Inclusion criteria:

          -  Ability to provide informed consent

          -  Current psychiatric inpatient (voluntary only) or outpatient treatment

          -  Meets Diagnostic and Statistical Manual of Mental Disorders (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, as defined by failure of at least two previous
             antidepressant or mood stabilizing treatments within the current depressive episode

          -  Failed antidepressant or mood stabilizing treatments can include pharmacotherapy for
             depression at an adequate dose for at least 8 weeks, or an acute series of at least 6
             administrations of electroconvulsive therapy (ECT)

          -  Ability to pass a comprehension assessment test related to effects of ketamine and
             trial objectives and criteria

        Exclusion Criteria:

          -  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