Ketamine for Depression and Suicide Risk
Condition: Depression; Suicide
MeSH terms: Depression; Depressive Disorder; Suicide
Intervention: Ketamine
Intervention description: 0.3 mg/kg/hr of ketamine infused for 100 minutes
Intervention MeSH terms: Ketamine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Depression; Unipolar; Bipolar; Suicidal

Summary:

      The purpose of this research study was to find out if the medication known as ketamine could
      help the symptoms of depression. This drug is approved by the U.S. Food and Drug
      Administration (FDA) as an anesthetic agent; however, it is not approved for use in
      depression treatment. The FDA allowed the use of this drug in this research study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Current psychiatric hospital inpatient at Mayo Clinic at time of initiation of
             treatment.

          -  Ability to provide informed consent

          -  Male/Female

          -  Age 18-65 yrs.

          -  Major Depressive Disorder or Bipolar Disorder I or Bipolar Disorder II with Patient
             Health Questionnaire-9 (PHQ 9) score ≥15 at hospital assessment

          -  Treatment resistant depression (TRD) as defined by at least two previous
             antidepressant or mood stabilizing treatments for depression in adequate dose for 8
             weeks

          -  Patient reported overall suicide risk score ≥3 on the Suicide Status Form (SSF II-R)
             or score of ≥1on Item 9 of PHQ-9 (all at admission assessment)

          -  Ability to pass comprehension assessment test related to effects of ketamine and trial
             objectives and criteria

          -  Voluntary admission

        Exclusion Criteria:

          -  Diagnosis of schizophrenia, schizoaffective disorder, or active psychosis

          -  Index episode of depression greater than 2 years

          -  Ongoing prescription of ≥4 mg lorazepam equivalents total daily or a.m. dosing of any
             benzodiazepine at time of assessment

          -  Currently undergoing electroconvulsive therapy, deep brain stimulation or transcranial
             magnetic stimulation as acute series or for maintenance

          -  Any active or unstable medical condition as judged by principal investigator

          -  Previous use or abuse of methamphetamine, cocaine, stimulants (prescribed and illicit)
             within past 12 months

          -  Any current abuse or dependence of alcohol or drugs (except nicotine) and abuse or
             dependence of drugs and alcohol only in full remission (> 1 month, < 12 months).
             Patients will be allowed to enroll if their drug and alcohol abuse / dependence is in
             full (complete, not partial) sustained (> 1 year) remission.

          -  History of traumatic brain injury

          -  Developmental delay and intellectual disorder

          -  Encephalopathy (clinical diagnosis within prior 12 months of delirium)

          -  Cognitive disorder (mild and major)

          -  Previous participation in earlier Ketamine trial

          -  Pregnancy

          -  Prisoners

          -  Involuntarily hospitalized