Ketamine as a Rapidly-Acting Antidepressant in Depressed Emergency Department Patients
Condition: Depression
MeSH terms: Emergencies; Depression
Intervention: Ketamine; Diphenhydramine
Intervention description: IV of Ketamine (.25mg/kg); Intravenous Diphenhydramine (25mg) at the time of presentation to Emergency Department
Intervention MeSH terms: Diphenhydramine; Promethazine; Ketamine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Ketamine; Ketlar; Depression; Antidepressants; Treatment; Acute

Summary:

      Investigators will conduct a trial to evaluate the use of Ketamine as an alternate treatment
      for people with Major Depressive Disorder. This study plans to explore the potential that
      Ketamine's rapid antidepressant action holds for improving outcomes in patients presenting to
      the Emergency Department with severe depression. Since this is a controlled trial we will use
      an IV of Ketamine or and equivalent volume of Diphenhydramine. Subjects will be randomly
      assigned to receive Ketamine or Benadryl. Investigators will then compare measures of mood
      pre- and post-infusion in the Emergency Department. To supplement self-reported measures of
      depressive symptoms(e.g. mood), investigators will obtain objective measures of the
      biological aspects of Major Depressive Disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Medically stable as determined by the medical physician

          -  Meets criteria for Major Depressive Disorder (MDD) based on a structured clinical
             Interview (MINI International Neuropsychiatric Interview).

          -  Reports symptoms of severe depression at the time of presentation, defined as a score
             of 24 or greater on the MADRS.

          -  Patients for whom a psychiatric evaluation and disposition decision has been made by
             emergency psychiatry staff to admit to an inpatient psychiatric unit at Bellevue
             Hospital Center or NYU Tisch Hospital.

          -  Each subject must have a level of understanding sufficient to sign an informed consent
             stating that the treatment being offered is not FDA approved for the treatment of
             depression and is being provided as an off-label option.

        Exclusion Criteria:

          -  Pregnancy

          -  Inability to read or understand English

          -  Current clinical signs of intoxication or delirium at time of study intervention

          -  Overdose, within previous 24 hours, of any agent which would impair ketamine
             metabolism

          -  Lifetime misuse/abuse of ketamine, phencyclidine (PCP),or related substances

          -  Lifetime history of psychotic spectrum illness

          -  First-degree relative with history of psychotic illness

          -  Lifetime diagnosis of borderline personality disorder, or as confirmed by assessment
             using items #90-104 of the SCID-II (for DSM-IV).

          -  Subjects with clinically significant abnormal findings as determined by medical
             history, physical examination, vital signs (blood pressure, heart rate, and
             respiration rate), O2 saturation measure, 12-lead ECG, clinical laboratory tests (CBC,
             chemistry panel, thyroid function tests), urine drug screen, and urine pregnancy test
             (for females of childbearing potential only).

          -  Clinically unstable medical, surgical or neurological conditions at ED presentation

          -  History of stroke or intracranial hypertension

          -  History of glaucoma

          -  Subjects with one or more seizures without a clear and resolved etiology

          -  Current NMDA antagonist medications (eg. Amantadine, Rimantadine, Lamotrigine,
             Memantine, Dextromethorphan)

          -  Known hypersensitivity to ketamine or amantadine

          -  Anti-psychotic medications (Typicals or Atypicals), with the exception of low-dose
             quetiapine (total daily dose of 100mg or less).

          -  Actively trying to commit suicide, even in a hospital setting

          -  Current homicide risk

          -  Unable or unwilling to give informed consent according to HIC guidelines

          -  Unable or unwilling to provide 2 contact phone numbers or be followed up per study
             protocol.

          -  Previous enrollment in this study.

          -  Concurrent enrollment in a research protocol investigating experimental pharmacologic
             treatments for depression at this or any other institution.