Ketamine for Suicidality in Bipolar Depression
Condition: Bipolar Disorder; Major Depressive Episode; Suicidal Ideation
MeSH terms: Depression; Bipolar Disorder; Suicidal Ideation
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study is designed to compare the effectiveness of two medications, Ketamine and
      Midazolam, for rapidly relieving suicidal thoughts in people suffering from bipolar
      depression.

      The first drug, ketamine, is an experimental antidepressant that early studies have shown may
      quickly reduce suicidal thoughts, but we are not sure how well it may work. Midazolam, the
      comparison drug, is not thought to reduce depression or suicidal thoughts.
    

Detailed description: 
      Patients currently taking psychiatric medications may continue them during the study.
      However, if a patient is taking a benzodiazepine (such as Ativan, Klonopin, or Xanax), they
      will be able to take up to 2mg per day of Lorazepam during the week before the infusion, but
      none will be permitted in the 24 hours pre-infusion. Also, Zolpidem (Ambien) will not be
      permitted in the 24 hours pre-infusion. If a person chooses to participate, their dose of
      benzodiazepine may need to be reduced so that they can do without it during the 24 hours
      pre-infusion.

      Participants are randomly assigned to receive a single dose of Ketamine (0.5 mg/kg) or
      Midazolam (0.02 mg/kg), which is given slowly, in a vein, over about 40 minutes. The study is
      "double-blind," meaning patients and study staff will not know which medication is in the
      infusion.

      If a patient does not respond to the first infusion, and s/he received Midazolam, then s/he
      will be offered the option of a second infusion, this time with Ketamine (0.5 mg/kg). After
      the infusion(s), participants will have weekly research interviews for 6 weeks to monitor
      response.

      After post-infusion research measures are completed, all subjects will receive open clinical
      treatment. During open clinical treatment, medication will be changed for those patients who
      don't respond or whose response is transient.

      Participation in this study requires a brief inpatient stay, at no cost, at the New York
      State Psychiatric Institute (NYSPI).

      Eligible participants enrolled in this study will be offered medication management visits at
      no cost for a total of up to 6 months combining inpatient and outpatient treatment. At the
      end of the 6 months of treatment patients will be referred for ongoing care.
    

Intervention name(s): Ketamine; Midazolam
Intervention type(s): Drug; Drug
Intervention description(s): Single dose of 0.5 mg/kg of Ketamine given intravenously (in the vein) over 40 minutes; Single dose of 0.02 mg/kg of Midazolam given intravenously (in the vein) over 40 minutes
Other intervention name(s): Ketalar; Ketamine Hydrochloride Injection; Midazolam Injection
Intervention MeSH terms: Midazolam; Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ketamine; Midazolam; Bipolar Disorder; Major Depressive Episode; Suicidal Ideation; Suicide; Depression; Treatment; Ketamine Treatment