Ketamine For Suicidal Ideation
Condition: Suicidal Ideation
MeSH terms: Suicidal Ideation
Study type: Interventional
Phase: Phase 4

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).
    

Detailed description: 
      Depression is a debilitating disorder that affects 12-20% of population and is among the top
      five leading causes of burden of disease worldwide (Kruijshaar ME 2005). Suicide associated
      with depression and other psychiatric disorders is a pervasive public health problem and
      results in almost one million deaths per year. Unfortunately, current treatments for severe
      depression have limited efficacy for suicidality, specifically due to the slow time course of
      change in suicidal thoughts. Recently ketamine, a glutamate-modulating agent, was shown to
      have antidepressant and anti-suicidal effect in outpatient depressed patients. The proposed
      study will test the ability of a single sub-anesthetic intravenous (IV) dose of the glutamate
      NMDA receptor antagonist, ketamine, to provide rapid decrease in suicidal ideation (SI) in
      patients hospitalized with SI. In this randomized parallel-arm placebo controlled trial,
      ketamine is compared to midazolam, which is expected to mimic some of the acute subjective
      effects of ketamine but not have any sustained antidepressant effects.

      Specific Aim 1: To determine feasibility and tolerability of a single low-dose IV infusion of
      ketamine in patients with prominent SI and elevated risk for suicide.

      Hypothesis 1: Ketamine administration will be feasible and well tolerated in patients
      admitted to a psychiatric hospital with SI.

      Specific Aim 2: To test the efficacy of a single IV dose of ketamine, compared to an
      anesthetic control condition (midazolam), to rapidly reduce SI in a controlled hospital
      setting.

      Hypothesis 2: Ketamine will be associated with significant and rapid reductions in SI and
      depressive symptoms within 24 hours.

      This study will test the rapid anti-suicidal effect of a single IV dose of the
      N-methyl-D-aspartate (NMDA) glutamate receptor antagonist ketamine in suicidality compared
      with the clinical response to a single IV dose of the short-acting benzodiazepine midazolam.
      Midazolam is able to induce transient neuropsychiatric effects mimicking ketamine and
      therefore is expected to protect the integrity of the blind. Participants will continue to
      receive standard treatment for their psychiatric condition throughout the trial. This unique
      "proof-of-concept" study in suicidal patients will be conducted over three-year period.
    

Intervention name(s): Ketamine; Midazolam
Intervention type(s): Drug; Drug
Intervention description(s): single dose IV ketamine, .5mg/kg infused over 40 minutes; single dose IV midazolam, .45mg/kg infused over 40 minutes
Other intervention name(s): N-methyl-D-aspartate (NMDA) glutamate receptor antagonist
Intervention MeSH terms: Midazolam; Ketamine; Excitatory Amino Acid Antagonists; N-Methylaspartate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: suicidal ideation; major depression; treatment resistant; ketamine; glutamate