Ketamine For Suicidal Ideation
Condition: Suicidal Ideation
MeSH terms: Suicidal Ideation
Intervention: Ketamine; Midazolam
Intervention description: single dose IV ketamine, .5mg/kg infused over 40 minutes; single dose IV midazolam, .45mg/kg infused over 40 minutes
Intervention MeSH terms: Midazolam; Ketamine; Excitatory Amino Acid Antagonists; N-Methylaspartate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: suicidal ideation; major depression; treatment resistant; ketamine; glutamate

Summary:

      This study will examine the effects of Intravenous (IV) ketamine both in an outpatient
      population and with subjects on the inpatient unit with suicidal ideation (SI).
    

Eligibility criteria:

        Inclusion Criteria:

          -  English speaking Male or female patients, 18-80 years

          -  Patients have voluntarily admitted themselves to an inpatient psychiatric unit at MSH
             or, regarding the outpatient population, have clinically significant suicidal ideation
             without intent to harm themselves

          -  Women of childbearing potential must have a negative pregnancy test

          -  Clinically significant suicidal ideation and score of ≥4 on MADRS item 10 for
             suicidality

          -  Each subject must have a level of understanding sufficient to agree to all tests and
             examinations required by the protocol and must sign an informed consent document

        Exclusion Criteria:

          -  Lifetime history of schizophrenia or other primary psychotic disorder

          -  Current presence of psychotic symptoms

          -  Lifetime history of a clearly established psychotic episode

          -  Established diagnosis of Schizoid, Schizotypal or Paranoid personality disorder

          -  Urine toxicology screen positive for drugs of abuse on admission

          -  Substance abuse or dependence within the preceding 1 month

          -  Anticipated discharge within 7 days of study enrollment (for patients in the inpatient
             arm)

          -  Women who plan to become pregnant, are pregnant or are breast-feeding

          -  Concurrent course of electroconvulsive therapy (ECT)

          -  Any unstable medical illness including hepatic, renal, gastro-enterologic,
             respiratory, cardiovascular, endocrinologic, neurologic, immunologic, or hematologic
             disease

          -  Clinically significant abnormal findings of laboratory parameters, physical
             examination, or ECG

          -  The presence of any known or suspected contraindications to midazolam or ketamine
             including, but not limited to, known allergic reactions to these agents or acute
             intermittent porphyria

          -  Uncontrolled hypertension, defined as BP systolic >160 or BP diastolic >100 on
             medications

          -  Arrhythmia requiring medication

          -  Severe coronary artery disease, defined as Canadian Cardiovascular Status III or IV